AGENDA PAPERS...The ICH Secretariat will provide a brief presentation to the Assembly on the use of the online platform for Members and Observers to have access to the agenda papers

AGENDA PAPERS

5 – 6 June 2019

Amsterdam, the Netherlands

Dated 24 May 2019

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ICH ASSEMBLY MEETING

FINAL AGENDA 5 & 6 June 2019

Amsterdam, the Netherlands

Opening of the ICH Assembly Meeting

Welcoming remarks from the ICH Assembly Chair Ms. Lenita Lindström-Gommers - EC, Europe, and ICH Assembly Vice-Chair Dr. Petra Doerr - Swissmedic, Switzerland.

The Assembly is invited to note the Member Representatives and Observer Delegates appointed to the Assembly as well as Ad-Hoc Observer Delegates participating in the Amsterdam meeting.

The Ad-Hoc Observer Delegates will be invited to provide brief introductory presentations to the Assembly.

The ICH Secretariat will provide a brief presentation to the Assembly on the use of the online platform for Members and Observers to have access to the agenda papers and background documents during the meeting.

Adoption of the Agenda

The Assembly is invited to adopt the agenda for the ICH Assembly meeting.

1. 2018 Annual Report of the Association

The ICH Management Committee (MC) will present to the Assembly the 2018 Annual Report of the Association developed by the ICH Secretariat with the input of the ICH MC and MedDRA MC. The Assembly is invited to take a decision to approve the 2018 Annual Report and the discharge of the ICH

MC, MedDRA MC and the ICH Secretariat for the activities undertaken by these bodies in 2018 on behalf of the ICH Association.

2. Membership and Observership

The ICH MC will present to the Assembly its recommendation regarding any Membership and/or Observership application(s) processed by the ICH MC since the meeting in Charlotte, NC, USA in November 2018.

The Assembly is invited to take a decision regarding any applications for ICH Membership and/or Observership recommended by the ICH MC.

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3. Procedural Matters

IFPMA expert participation

IFPMA will be invited to present to the Assembly its process related to facilitating the participation of IFPMA National Association experts in Working Groups.

The Assembly is invited to share its views on the report.

General

The ICH Assembly Chair/Vice Chair will inform the Assembly on ICH MC consideration of changes to ICH procedural documents in view of recent MC and/or Assembly discussions, including on: the management of the size of ICH Working Groups in view of ICH’s growing number of Members and Observers; the definitions of the degrees of implementation of ICH Guidelines approved by the Assembly in Charlotte, NC, USA in November 2018; as well as the need identified for certain clarifications.

Articles of Association

The ICH Assembly Chair/Vice-Chair will inform the Assembly on amendments proposed to the ICH Articles of Association which were last updated and approved by the Assembly in Kobe, Japan in June 2018. The Assembly is invited to take a decision to adopt the revised Articles of Association.

Assembly Rules of Procedure

The ICH Assembly Chair/Vice-Chair will inform the Assembly on amendments proposed to the Assembly Rules of Procedures (RoP) which were last updated and approved by the Assembly in Charlotte, NC, USA in November 2018.

The Assembly is invited to take a decision to adopt the revised Assembly RoP.

ICH Management Committee Rules of Procedure

The ICH MC will inform the Assembly on updates made by the ICH MC to the ICH MC RoP which were last updated and approved by the ICH MC in Charlotte, NC, USA in November 2018.


Standard Operating Procedures of ICH Working Groups

The ICH MC will inform the Assembly on updates made by the ICH MC to the Standard Operating Procedures (SOPs) of ICH Working Groups (WGs) which were last updated and approved by the ICH MC in Charlotte, NC, USA in November 2018.


MedDRA Management Committee Rules of Procedure

The MedDRA MC Chair’s Delegate will inform the Assembly on updates made by the MedDRA MC to the MedDRA MC RoP which were last updated and approved by the MedDRA MC in Kobe, Japan in June 2018.


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4. General Operational Matters

ICH General Operational Matters

The ICH Secretariat will update the Assembly on general operational matters including:

• ICH Secretariat implementation of recent Assembly/MC decisions and current procedures, and support of WG operations;

• Participation of Member and Observer experts in ICH. The Assembly is invited to share its views on the update.

IPRP Cooperation

The Chair of the International Pharmaceutical Regulators Programme (IPRP) will be invited to provide an update on IPRP activities and ICH Secretariat’s provision of services to the IPRP and on any consideration regarding the renewal of the Memorandum of Understanding (MoU) between ICH and IPRP for the provision of Secretariat services for the year 2020.

The Assembly is invited to share its views on the update.

5. Update on MedDRA

The MedDRA MC Chair’s Delegate will provide a report on current MedDRA activities. The Assembly is invited to share its views on the report.

6. Implementation of ICH Guidelines

General

The Assembly is invited to note the status of implementation of ICH Guidelines by ICH Regulatory Members which is published on the ICH website.

Implementation survey

The ICH MC will provide an update on the outcome of the ICH-driven implementation survey for Monitoring the Adequacy of Implementation and Adherence to ICH Guidelines for Regulators and Industry which was conducted in March 2019.

The Assembly is invited to provide its views.

7. Training

The ICH MC will update the Assembly on training related activities and on considerations on the ICH training approach, including the status of work with ICH Recognised Training Programme Providers; ICH support of regional training on ICH Guidelines by ICH Regulatory Members, and outcome of the call for Expression of Interest for ICH Training Associates conducted in April/May 2019.

The Assembly is invited to share its views on the update;

The Assembly is invited to discuss possible next steps for Training activities in consideration of the results of the implementation survey for Monitoring the Adequacy of Implementation and Adherence to ICH Guidelines.

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8. Financial Matters

The ICH MC will provide an update on ICH financial matters including on the 2018 Audited Accounts and Financial Statements; updated 2019 and 2020 provisional ICH budget; preparation of the 5-year 2020-2024 ICH budget projection; and considerations on long-term plan for strategic use of ICH funds.

The MedDRA MC Chair’s Delegate will provide an update on MedDRA financial matters, including on the 2020 provisional MedDRA budget 5-year 2020-2024 MedDRA budget projection. The Assembly is invited to share its views on the update; The Assembly is invited to take a decision to approve the 2018 Audited Accounts and Financial Statements

of the ICH Association which will then be filed with the 2018 tax return of the ICH Association; The Assembly is invited to take a decision to approve any proposed updates to the 2019 ICH budget further

to its discussions in Amsterdam; The Assembly is invited to take a decision to approve the updated provisional 2020 ICH budget.

9. New Topic Process & Strategic Discussions

New Topic Proposals

The ICH MC will present its assessment of the New Topic proposals which were submitted by ICH Members in December 2018. The Assembly is invited to share its views and to take a decision to approve any New Topic proposals and

associated Concept Paper Outline. Further to any endorsement by the Assembly, the ICH Secretariat will issue a call for expression of interest from ICH Members and Observers to nominate experts.

Strategic Reflection Papers

The ICH MC will present the status of work regarding development by ICH Members of draft Reflection Papers on: Strategic Approach to International Harmonization of Technical Scientific Requirements for Pharmacoepidemiological Studies Submitted to Regulatory Agencies to Advance More Effective Utilization of Real-World Data, and on Model Informed Drug Development (MIDD). The Assembly is invited to provide its views.

Strategic Discussions

The ICH MC will inform the Assembly on its discussion regarding refinement of the process related to strategic priority planning and development of Reflection Papers. The Assembly is invited to provide its views.

10. Communication

Communication activities

The ICH MC will update the Assembly on its considerations regarding the commemorations of the 30th anniversary of ICH in 2020. The ICH Secretariat will update the Assembly on its recent activities aimed at improving ICH communication with stakeholders. The Assembly is invited to provide its views on the update.

ICH Regional Public Meetings

Assembly Members and Observers are invited to share information on any ICH Regional Public Meetings in their respective regions prior to/following the ICH meeting in Amsterdam in June 2019.

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11. WGs Meeting in Amsterdam

11.1. E2B(R3) EWG/IWG: Revision of the Electronic Submission of Individual Case Safety Reports (Rapporteur: Dr. Misu – MHLW/PMDA, Japan; Regulatory Chair: Mr. Chen – FDA, United States)

The Rapporteur will report on the outcome of the meeting of the E2B(R3) EWG/IWG, including the progress made on: the Route of Administration (RoA) term mapping between the ICH E2B code list and the EDQM Standard Terms; the planning of the publication of extracted EDQM Dose Form (DF) and RoA terminologies as ICH code lists; the development of a first draft of training materials for E2B(R3) adopters; the processing and update of Q&As; the update of the Implementation Guide package; the monitoring of regional IDMP implementation; as well as on the outcome of the joint meeting with the M2 EWG to finalize a Service Level Understanding regarding the Standard Operation Procedure to extract and post the EDQM DF and RoA terminology for E2B(R3) use.

The Assembly is invited to share its views on the report;

If Step 3 of the updated E2B(R3) Implementation Guide package is signed-off by the Regulatory TopicLeaders of the E2B(R3) EWG/IWG, the Regulatory Members of the Assembly are invited to take a decisionto adopt Step 4.

Background Document: • E2B(R3) EWG/IWG Work Plan, dated 1 February 2019.

11.2. E8(R1) EWG: Revision on General Considerations for Clinical Trials (Rapporteur: Dr. LaVange – FDA, United States; Regulatory Chair: Dr. Sweeney – EC, Europe)

Step 2b of the E8(R1) draft Guideline was reached electronically in May 2019, further to which the E8(R1) draft Guideline was issued for public consultation. The ICH Secretariat is in the process of soliciting ICH Regulatory Member feedback on their respective public consultation deadlines.

The Rapporteur will report on the outcome of the meeting of the E8(R1) EWG, including on the drafting of training materials; and the planning of the ICH E8(R1) public stakeholder meeting.


Steps 3 and 4 are expected by June 2020.

Background Document:

• E8(R1) EWG Work Plan, dated 7 January 2019.

11.3. E9(R1) EWG: Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses (Acting Rapporteur: Dr. Petavy – EC, Europe; Regulatory Chair: Dr. Ando – MHLW/PMDA, Japan)

Step 2b of the E9(R1) draft Addendum was reached electronically in August 2017, further to which the E9(R1) Step 2b draft Addendum was issued for public consultation ending in May 2018.

The Acting Rapporteur will report on the outcome of the meeting of the E9(R1) EWG, including the progress made towards addressing the comments received during the regional public consultation.


The Assembly is invited to take a decision to endorse the nomination of the current Acting Rapporteur asthe formal Rapporteur for the E9(R1) EWG in line with the Assembly RoP Section 4.2;

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If Step 3 of the E9(R1) draft Technical Document is signed-off by the Regulatory Topic Leaders of theE9(R1) EWG, the Regulatory Members of the Assembly are invited to take a decision to adopt Step 4.

Steps 3 and 4 are expected by June/September 2019.


• E9(R1) EWG Work Plan, dated 27 February 2019.

11.4. E11A EWG: Paediatric Extrapolation (Rapporteur: Dr. Yao – FDA, United States)

The E11A EWG was established further to approval of the E11A Concept Paper and Business Plan in October 2017. The E11A EWG is currently divided into 3 subgroups to work on disease similarity; modelling and simulation; and statistics.

The Rapporteur will report on the outcome of the meeting of the E11A EWG, including the progress made on the E11A draft Technical Document.


Steps 1 and 2a/b are expected by November 2020.


• E11A EWG Work Plan, dated 31 January 2019.

11.5. E14/S7B IWG: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs (Rapporteur: Dr. Strauss – FDA, United States; Regulatory Chair: Dr. Shinagawa – MHLW/PMDA, Japan)

The E14/S7B IWG was established in November 2018 further to approval of the E14/S7B Concept Paper.

The Rapporteur will report on the outcome of the meeting of the E14/S7B IWG, including the progress made on the development of the first stage of Q&As.


Finalisation of the first stage of Q&As is expected by June 2020.


• E14/S7B IWG Work Plan, dated 20 February 2019.

11.6. E17 IWG: Multi-Regional Clinical Trials (Rapporteur: Dr. Dunder – EC, Europe; Regulatory Chair: Mr. Otsubo – MHLW/PMDA, Japan)

The E17 IWG was established in February 2018 further to approval of the E17 Concept Paper.

The Rapporteur will report on the outcome of the meeting of the E17 IWG, including the progress made on the finalisation of the 7 training modules.


If finalised, the Assembly is invited to take a decision to approve the final E17 Training Materials forpublication on the ICH website.

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The finalisation of the training materials is expected by June 2019.


• E17 IWG Work Plan, dated 4 February 2019.

11.7. M2 EWG: Electronic Standards for the Transfer of Regulatory Information (ESTRI) (Co-Rapporteurs: Ms. Slack – FDA, United States / Dr. Okada – MHLW/PMDA, Japan; Regulatory Chair: Dr. Jaermann – Swissmedic, Switzerland)

The Rapporteur will report on the outcome of the meeting of the M2 EWG, including the progress made on the White Paper on the potential of the HL7 Fast Healthcare Interoperability Resources (FIHR) standard for ICH initiatives and on the outcome of the meeting with HL7’s Chief Technology Officer to discuss the White Paper; any project opportunities proposals and the joint meetings with: the E2B(R3) EWG/IWG to discuss considerations of FHIR and other technical questions, and the M11 EWG to establish a working arrangement and plan for development of a technical specification.



• M2 EWG Work Plan, dated 1 February 2019.

11.8. M7(R2) Maintenance EWG/IWG: Addendum to Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (Rapporteur: Dr. Honma – MHLW/PMDA, Japan; Regulatory Chair: N/A)

The M7(R2) Maintenance EWG/IWG initiated work in November 2018 on the development of Q&As further to the approval of its revised Concept Paper.

The Rapporteur will report on the outcome of the meeting of the M7(R2) Maintenance EWG/IWG, including the progress made on the M7(R2) revision; the work related to the second Addendum for new impurities; and on the development of the Q&As document.


If finalised, the Assembly is invited to take a decision on whether to approve the list of compounds for thesecond Addendum with consideration of the MC’s recommendation as per the Maintenance Procedureincluded in Annex 4 of the SOP;

The Assembly is invited to note that the Rapporteurship of the group should rotate amongst the FoundingRegulatory Members as per the Maintenance Procedure included in Annex 4 of the SOP of the WGs, and totake a decision to approve the transition of Rapporteurship to EC, Europe for the next two years from theend of the Amsterdam meeting.

Steps 1 and 2a/b for the revised M7(R2) draft Guideline (including the revised second Addendum) are expected by November 2019.

Steps 1 and 2a/b for M7(R2) Q&As are expected by November 2019.


• M7 Maintenance EWG/IWG Work Plan, dated 1 February 2019.

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11.9. M9 EWG: Biopharmaceutics Classification System-based Biowaivers (Rapporteur: Dr. Welink – EC, Europe; Regulatory Chair: Dr. Seo – FDA, United States)

Further to Assembly endorsement of Step 2a/b at the meeting in Kobe, Japan in June 2018, the M9 Step 2b draft Guideline underwent public regulatory consultation in the ICH Member regions until end of January 2019.

The Rapporteur will report on the outcome of the meeting of the M9 EWG, including the progress made towards addressing the comments received during the regional public consultation.


If Step 3 of M9 draft Technical Document is signed-off by the Regulatory Topic Leaders of the M9 EWG,the Regulatory Members of the Assembly are invited to take a decision to adopt Step 4.

Steps 3 and 4 are expected in June 2019.



11.10. M11 EWG: Clinical electronic Structured Harmonized Protocol (CeSHarP) (Acting Rapporteur: Ms. Combs – PhRMA; Regulatory Chair: Dr. Fitzmartin – FDA, United States)

The M11 EWG was established in November 2018 further to approval of the M11 Concept Paper and Business Plan.

The Acting Rapporteur will report on the outcome of the meeting of the M11 EWG, including the progress made on the M11 draft Technical Document.


The Assembly is invited to take a decision to endorse the nomination of the current Acting Rapporteur asthe formal Rapporteur for the M11 EWG in line with the Assembly RoP Section 4.2.

Steps 1 and 2a/b are expected by July 2020.



11.11. Q2(R2)/Q14 EWG: Analytical Procedure Development and Revision of Q2 (R1) Validation of Analytical Procedures (Rapporteur: Dr. Hiyama – MHLW/PMDA, Japan; Regulatory Chair: Dr. Keire – FDA, United States)

The Q2(R2)/Q14 EWG was established in November 2018 further to the approval of the Q2(R2)/Q14 Concept Paper and Business Plan.

The Q2(R2)/Q14 EWG is currently divided into 3 subgroups to work on the revision of the Q2(R1) Guideline, the development of the Q14 draft Technical Document, and on the coordination of the work between the two activities.

The Rapporteur will report on the outcome of the meeting of the Q2(R2)/Q14 EWG, including the progress made on the Q2(R2)/Q14 draft Technical Document, and the joint meeting with the Q12 EWG with a view to ensuring that both Guidelines are well aligned.


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Steps 1 and 2 a/b are expected by June 2020.


• Q2(R2)/Q14 EWG Work Plan, dated 15 February 2019.

11.12. Q3D(R2) Maintenance EWG: Maintenance of the Guideline for Elemental Impurities (Rapporteur: Dr. McGovern – FDA, United States; Regulatory Chair: N/A)

Steps 3 and 4 on the Q3D(R1) revision of the Cadmium Inhalation Permitted Daily Exposure (PDE) were reached electronically in March 2019.

The Rapporteur will report on the progress of the meeting of the Q3D(R2) Maintenance EWG, as the Q3D(R2) Maintenance EWG continues its work on the development of PDEs for cutaneous and transdermal Routes of Administration.

The Assembly is invited to note that the Rapporteurship of the group should rotate amongst the FoundingRegulatory Members as per the Maintenance Procedure included in Annex 4 of the SOP of the WGs, and totake a decision to approve the transition of Rapporteurship to MHLW/PMDA, Japan for the next two yearsfrom the end of the Amsterdam meeting.

Steps 1 and 2a/b of the Q3D(R2) revision for the cutaneous and transdermal products are expected by June 2019.


• Q3D(R2) Maintenance EWG Work Plan, dated 1 February 2019.

11.13. Q12 EWG: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Rapporteur: Ms. Boam – FDA, United States; Regulatory Chair: Ms. Kruse – EC, Europe)

Step 2b on the Q12 draft Guideline was reached at the meeting in Geneva, Switzerland in November 2017, further to which the Q12 Step 2b draft Guideline was issued for public consultation ending in December 2018.

The Q12 EWG held an interim meeting in Tokyo, Japan in February 2019.

The Rapporteur will report on the outcome of the meeting of the Q12 EWG, including the progress made towards addressing the comments received during the regional public consultation period, the work on the accompanying Annex, and the joint meeting with the Q2(R2)/Q14 EWG.


Steps 3 and 4 are expected by November 2019.


• Q12 EWG Work Plan, dated 25 February 2019.

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11.14. Q13 EWG: Continuous Manufacturing of Drug Substances and Drug Products (Rapporteur: Dr. Lee – FDA, United States; Regulatory Chair: Dr. Matsuda – MHLW/PMDA, Japan)

The Q13 EWG was established in November 2018 further to approval of the Q13 Concept Paper and Business Plan.

The Rapporteur will report on the outcome of the meeting of the Q13 EWG, including the progress made on the development of the Q13 draft Technical Document.


Steps 1 and 2 a/b are expected by June 2020.


• Q13 EWG Work Plan, dated 21 February 2019.

11.15. S5(R3) EWG: Revision on Detection of Toxicity to Reproduction for Human Pharmaceuticals (Rapporteur: Dr. Waxenecker – EC, Europe; Regulatory Chair: N/A)

Step 2b of the S5(R3) draft Guideline was reached electronically in August 2017, further to which the S5(R3) Step 2b draft Guideline was issued for public consultation ending in March 2018.

The Rapporteur will report on the outcome of the meeting of the S5(R3) EWG, including the progress made towards addressing the comments received during the regional public consultation period, and on the proposed maintenance procedure for the S5 Annexes.


The Assembly is invited to take a decision to endorse the new area of work of the S5(R3) EWG as outlinedin the Maintenance Procedure Concept Paper.



• S5(R3) EWG Work Plan, dated 23 January 2019.

11.16. S11 EWG: Nonclinical Safety Testing in Support of Development of Paediatric Medicines (Rapporteur: Dr. Brown – FDA, United States; Regulatory Chair: Dr. van der Laan – EC, Europe)

Step 2b of the S11 draft Guideline was reached electronically in September 2018, further to which the S11 Step 2b draft Guideline was issued for public consultation ending in April 2019.

The Rapporteur will report on the outcome of the meeting of the S11 EWG, including the progress made towards addressing the comments received during the regional public consultation period.




• S11 EWG Work Plan, dated 1 February 2019.

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12. WGs Not Meeting in Amsterdam

The Assembly will note the status and the work plans of the groups not meeting.

The Coordinators will raise any items requiring discussion or decision by the Assembly.

The Assembly is invited to provide any input and take any decision as needed.

12.1. Standing Paediatric EWG (Rapporteur: Dr. Hirata – MHLW/PMDA, Japan; Regulatory Chair: Dr. Yao – FDA, United States)

The Standing Paediatric EWG was established in February 2018 to act as a continuous resource available for expert consultation and guidance to WGs charged with developing new or revised Guidance which may be of relevance to paediatric drug development.

The Standing Paediatric EWG did not receive any request for paediatric advice and remains available for expert consultation and guidance to WGs charged with developing new or revised guidance which may be of relevance to paediatric drug development.

12.2. E19 EWG: Optimization of Safety Data Collection (Rapporteur: Dr. Thanh Hai – FDA, United States; Regulatory Chair: Dr. Mol - EC, Europe)

Step 2b on the E19 draft Guideline was reached electronically in April 2019, further to which the E19 Step 2b draft Guideline was issued for public consultation. The ICH Secretariat is in the process of soliciting ICH Regulatory Member feedback on their respective public consultation deadlines.

The E19 draft Guideline is currently undergoing public regulatory consultation in the ICH Member regions.

Steps 3 and 4 are expected by June 2021.


• E19 EWG Work Plan, dated 31 January 2019.

12.3. E20 informal Working Group: Adaptive Clinical Trials (Informal Working Group Lead and Regulatory Chair to be determined)

The Assembly adopted the E20 Concept Paper outline at its meeting in Kobe, Japan in June 2018 with a delayed starting timeframe, and the MC confirmed in Charlotte, NC, USA in November 2018 that the E20 informal WG would begin work on the E20 Concept Paper and Business Plan in June/July 2019.

The E20 informal WG will shortly initiate work on the development of the E20 Concept Paper and Business Plan.

The Assembly is invited to note that PhRMA, as the Member who proposed the topic, has agreed to lead theinformal WG (as per section 1.2 of the SOP).

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12.4. M1 PtC WG: MedDRA Points to Consider (Rapporteur: Dr. Winter – EFPIA; Regulatory Chair: Dr. Brajovic – FDA, United States)

The “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents, updated for MedDRA Version 22.0, were released in March 2019.

The M1 PtC WG continues its work on the updating with each MedDRA release of the MedDRA Term Selection: Points to Consider and MedDRA Data Retrieval and Presentation: Points to Consider documents.

Release of next versions of the “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider documents” (updated for MedDRA Version 22.1) is expected in September 2019.



12.5. M4Q(R1) IWG: (CTD-Quality) IWG: Addressing CTD-Q-Related Questions (Rapporteur: Dr. Schmuff – FDA, United States; Regulatory Chair: N/A)

The M4Q(R1) IWG remains in a dormant state since the ICH meeting in Osaka, Japan, in November 2016 in case questions are received which would need to be addressed by the M4Q(R1) IWG following the implementation of the revised M4 Granularity Document.

No questions were so far received following the implementation of the revised M4 Granularity Document which would need to be addressed by the M4Q(R1) IWG.

12.6. M8 EWG/IWG: The Electronic Common Technical Document (eCTD) (Rapporteur: Mr. Gray – FDA, United States; Regulatory Chair: Ms. Puusaari – EC, Europe)

The eCTD v4.0 Q&As and Specification Change Request Document v1.2, as well as the eCTD v3.2.2 Q&As and Specification Change Request Document v1.31 reached Steps 3 and 4 at the meeting in Kobe, Japan, in June 2018.

No Change Requests were received since the meeting in Kobe, Japan, in June 2018. The M8 EWG/IWG held a teleconference with the M2 EWG in April 2019 to discuss implications of HL7 FHIR and potential paths forward for eCTD.


• M8 EWG/IWG Work Plan, dated 14 February 2019.

12.7. M10 EWG: Bioanalytical Method Validation (Rapporteur: Dr. Ishii-Watabe – MHLW/PMDA, Japan; Regulatory Chair: Dr. Booth – FDA, United States)

Step 2b on the M10 draft Guideline was reached electronically in February 2019, further to which the M10 Step 2b draft Guideline was issued for public consultation. The ICH Secretariat is in the process of soliciting ICH Regulatory Member feedback on their respective public consultation deadlines.

The M10 Step 2b draft Guideline is currently undergoing public regulatory consultation in the ICH Member regions.



• M10 EWG Work Plan, dated 30 January 2019.

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12.8. M12 informal Working Group: Drug Interaction Studies (Informal Working Group Lead and Regulatory Chair to be determined)

The Assembly adopted the M12 Concept Paper outline at its meeting in Kobe, Japan in June 2018, and the MC approved in Charlotte, NC, USA in November 2018 the establishment of the M12 informal WG with a delayed timeframe such that the group will begin work on the M12 Concept Paper and Business Plan in June/July 2019.

The M12 informal WG will shortly initiate work on the development of the M12 Concept Paper and Business Plan.

The Assembly is invited to note that FDA, United States, as the Member who proposed the topic, has agreedto lead the informal WG (as per section 1.2 of the SOP).

12.9. Q3C(R8) Maintenance EWG: Maintenance of the Guideline for Residual Solvents (Rapporteur: Dr. McGovern – FDA, United States; Regulatory Chair: N/A)

In October 2018, the ICH Q3C(R7) Guideline was published further to an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol.

The Q3C(R8) Maintenance EWG continues to work on the development of Permitted Daily Exposure (PDE) levels for the solvents 2-methyltetrahydrofuran, cyclopentylmethylether and tert-butanol.

The Assembly is invited to note that although the Rapporteurship of the group should rotate amongst theFounding Regulatory Members as per the Maintenance Procedure included in Annex 4 of the SOP of theWGs, the Founding Regulatory Members were supportive that the Rapporteurship of Q3C(R8) should remainwith FDA, United States for the next two years, and to take a decision to approve the continuedRapporteurship by FDA, United States for the next two years.

Steps 1 and 2a/b are expected by Mid-2019.


• Q3C(R8) Maintenance EWG Work Plan, dated 1 February 2019.

12.10. Q11 IWG: Q&As on Selection and Justification of Starting Materials for the Manufacture of Drug Substances (Rapporteur: Mr. McDonald – EC, Europe; Regulatory Chair: Dr. Condran – Health Canada, Canada)

The Assembly is invited to note that the Q11 IWG was disbanded in May 2019, following the publication ofthe Q11 training materials on the ICH public website and the completion of the Q11 IWG work.

12.11. S1(R1) EWG: Revision of the Rodent Carcinogenicity Studies for Human Pharmaceuticals Guideline (Rapporteur: Dr. Sistare – PhRMA; Regulatory Chair: Dr. Van der Laan – EC, Europe)

The S1(R1) EWG continues its work on the review of confidential Carcinogenicity Assessment Documents (CADs) and final Study Reports (FSRs), and on drafting the revisions to the S1B Guideline.

Steps 1 and 2a/b are expected by November 2019.


• S1(R1) EWG Work Plan, dated 18 February 2019.

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12.12. Informal Generic drug Discussion Group (IGDG) (Rapporteur: Dr. Tampal – FDA, United States; Regulatory Chair: Dr. Welink – EC, Europe)

Further to the Assembly endorsement of the Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs in November 2018, and the MC endorsement of the IGDG remit document in January 2019, the IGDG was established in April 2019.

The IGDG continues its work as per the IGDG remit.

12.13. Informal Quality Discussion Group (IQDG) (Rapporteur: Mr. Nosal – PhRMA; Regulatory Chair: Ms. Kruse – EC, Europe)

The IQDG was established in February 2019 further to the Assembly’s endorsement of the Reflection Paper on Advancing Biopharmaceutical Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches at its meeting in Kobe, Japan in June 2018, and to the MC approval of the IQDG remit document at its meeting in Charlotte, NC, USA in November 2018.

The IQDG continues its work on the development of an Assessment Process establishing criteria to review/triage existing Quality and other relevant Multidisciplinary ICH Guidelines, ICH Guidelines in progress, and newly proposed Quality topics.


• IQDG Work Plan, dated 8 April 2019.

13. Q4B Maintenance

The ICH Secretariat will provide a short update on considerations on the timeframe for the next steps regarding the revision of the Q4B Guideline and Annexes, as described in Annex 5 of the SOP of the WGs, further to the Assembly’s decision in November 2018 to revise the maintenance process for Q4B Annexes.


14. Appointment of ICH Assembly Vice Chair

In view of the current Assembly Vice Chair needing to step down after the Amsterdam meeting, the Assembly will note the nomination(s) received for a new Assembly Vice-Chair who would serve the remaining 6 months of the term until November 2019.

The Assembly Members will be invited to vote via secret ballot on the appointment from the end of themeeting of the new Assembly Vice-Chair from amongst the eligible applicants in line with the AssemblyRules of Procedure Section 3.1.

15. Organisation of Next Meetings

The Assembly will receive an update on the organisation of next ICH meetings with the new schedule where the Assembly meets on Tuesday and Wednesday morning, as well as on 2020 and 2021 selected dates and locations.

Page 15 of 15

Any Other Business

The Assembly is invited to raise any other business for discussion.

Summary of Assembly Decisions in Amsterdam

The ICH Secretariat will provide a summary of Assembly decisions taken during the meeting.

The Assembly is invited to provide any comments on the summary of Assembly decisions.

Press Release

The Assembly will be informed on the development and publication of the ICH Press Release for the meeting.

WGs Meeting in Amsterdam

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ICH E2B(R3) EWG/IWG Work Plan February 01, 2019

Topic Adoption date: July 2013

Rapporteur: Dr. Takashi Misu - MHLW/PMDA, Japan

Regulatory Chair: Mr. Ta-Jen Chen – FDA, United States

Last Face-to-Face Meeting: Kobe, Japan, June 2018

1. Key milestones

1.a. Current status of key milestones

Past completion date Milestone

Jun. 2018 Step 4 sign-off of the revised E2B(R3) Q&A document Endorsement of the common template of core data elements and business rules

Sep. 2018 Published the updated IG package (ver. 1.07) and the updated Q&A document (ver. 2.2)

Dec. 2018 Made a decision about the Route of Administration (RoA) terminology mapping between the ICH E2B code list and EDQM standard terms

1.b. Future anticipated key milestones

Expected future completion date Milestone

Jun. 2019 Finalize a service level understanding (SLU) with M2 regarding the SOP to extract and post the EDQM dose form (DF) and RoA terminology lists for E2B(R3) use

Jun. 2019 Plan the publication of extracted EDQM DF and RoA terminologies as ICH code lists

Jun. 2019 Complete the RoA term mapping table between the ICH E2B code list and EDQM standard terms

Jun. 2019 Update IG package: revise the Appendix I(B) Backwards and Forwards Compatibility (BFC) Recommendations and the Appendix I(G) Technical Information for EDQM terminology use in E2B(R3) messages

Jun. 2019 Process and update Q&As as needed

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Jun. 2019 Develop first draft training materials for E2B(R3) adopters

Jun. 2019 Develop business requirement for EDQM Application Programming Interface (API) for use of E2B(R3)

2. Timeline for specific tasks

Beginning date

End date Task / Activity Details

Jul. 2018 Jun. 2019 Finalize a SLU with M2 regarding the SOP to extract and post the EDQM DF and RoA terminology lists for E2B(R3) use

Review the draft SLU developed by M2 and provide feedback to M2

Finalize the SLU with M2

Jul. 2018 Jun. 2019 Plan the publication of extracted EDQM DF and RoA terminologies as ICH code lists

Consult with M2 about technical issues of the publication

Make a plan of the publication of the DF and RoA terminologies as ICH code lists

Dec. 2018 Jun. 2019 RoA term mapping between the ICH code list and EDQM standard terms

Develop a mapping table based on the E2B decision regarding the five EDQM proposals

Dec. 2018 Jun. 2019 Developing first draft training materials for E2B(R3) adopters

Draft the plan for developing training materials

Consider contents depending on the target of training materials

Develop first draft of the training materials

Dec. 2018 Jun. 2019 Update IG package: revise the Appendix I(B) Backwards and Forwards Compatibility Recommendations and the Appendix I(G) Technical Information for EDQM terminology use in E2B(R3) messages

Revise the BFC recommendation and the Technical Information

Update the IG package

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Dec. 2018 Jul. 2019 Process and update Q&As as needed

Monitor and discuss any comments submitted to the ICH mail box and/or from E2B experts

Add new Q&As to the document if applicable

Dec. 2018 Jun. 2019 Develop business requirement for EDQM API for use of E2B(R3)

Evaluate the functions of EDQM API

Consider business requirements for dynamic refresh of EDQM DF and RoA term list by each party

Gather requirements from all parties for dynamic refresh of EDQM DF and RoA term lists

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ICH E8(R1) EWG Work Plan 07 January 2019

Topic Adoption date: November 2017

Rapporteur: Dr. Lisa LaVange, FDA, United States

Regulatory Chair: Dr. Fergus Sweeney, EC, Europe

Last Face-to-Face Meeting: Charlotte, NC, USA - November 2018

1. Key milestones



Nov. 2017 Concept Paper endorsement, Business Plan endorsement

Jan. 2019 Feedback from internal ICH Stakeholders, including webinar



Feb. 2019 Step 1. All experts Sign-off on the technical Document (electronically)

Mar. 2019 Step 2a and 2b: Endorsement of draft Guideline by Members and by Regulatory Members of the Assembly (electronically)

Oct. 2019 End of Public Consultation Period

After Oct. 2019 Public Meeting with Stakeholders

Jun. 2020 Step 4: Adoption of an ICH Harmonised Guideline

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Beginning date


Jan. 2019 Jan. 2019 EWG teleconference Revise and Clarify Document Remove redundancy

Feb. 2019 Feb. 2019 EWG teleconference Revise and Clarify Document Remove redundancy

Mar. 2019 Mar. 2019 EWG teleconference Plan presentation at DIA, draft training materials/examples

Apr. 2019 Apr. 2019 EWG teleconference Draft training materials/examples

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ICH E9(R1) EWG Work Plan 27 February 2019

Topic Adoption date: October 2014

Rapporteur: Dr. Franck Petavy, EC, Europe

Regulatory Chair: Dr. Yuki Ando, MHLW/PMDA, Japan

Last Face-to-Face Meeting: Charlotte, NC, USA, November 2018

1. Key milestones



Oct. 2014 Concept Paper endorsement by the ICH Steering Committee.

2017

Step 1 and Step 2a/b - Finalisation of the Technical Document (draft addendum), sign-off by Topic Leaders and adoption by Assembly Members and by Assembly Regulatory Members.

Aug. 2017 Step 3 - Draft addendum published.

Apr. 2018 Step 3 - Public comments received in all ICH regions.

Aug. 2018 Publication of Step 2b training material slide decks on the ICH website



2019 Step 3 - Discuss comments received during the public consultation period and consolidate the draft addendum.

2019 Organise and participate to trainings and scientific meetings, within ICH parties and at international congresses.

2019 Step 3 and Step 4 - Finalisation of the addendum and sign-off by topic leaders of the ICH Regulatory Parties and by the ICH Regulatory Parties.

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Beginning date

End Date Task / Activity Details

Dec. 2017 Early 2019 Step 3 Organise or participate at meetings at a global or regional level to promote awareness and comments on the addendum. Discuss regional consultation comments and modify the addendum and accompanying documents, based on comments received. Outline plans for further progress towards finalisation.

Jan. 2018 Early 2019 In parallel with Step 3

Discuss methodological issues related with estimands and sensitivity analysis in clinical trials. Consider the relationship of ICH E9(R1) with other ICH documents.

Jun. 2019 Sep. 2019 Step 3 and Step 4 Finalise the addendum and any accompanying documents. Once all documents are finalised, engage the sign-off process. Step 3: Sign-off by topics leaders of Regulatory ICH Parties. Step 4: Adoption by ICH Assembly Regulatory Members. Plan for training and implementation activities, including the update of E9(R1) Step 2 slides.

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ICH E11A EWG Work Plan 31 January 2019

Topic Adoption date: 17 October 2017

Rapporteur: Dr. Lynne Yao - FDA, United States

Regulatory Chair: N/A


1. Key milestones



Oct. 2017 Concept Paper endorsed by Management Committee

Oct. 2017 Business Plan endorsed by Management Committee

Jun. 2018 Completed review of global literature on pediatric extrapolation

Jun. 2018 Completed review of pediatric extrapolation issues from E11(A) public comments

Nov. 2018 Completed draft Table of Contents Outline of Guideline



Nov. 2020 Step 1 Consensus Building, Drafting of Technical Document

Nov. 2020 Step 2a and 2b Endorsement of Draft Guideline by Assembly Members and Assembly Regulatory Members

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Beginning date


Jun. 2018 Ongoing Creation and Continued work of EWG Subgroups

Three subgroups were created to lead specific topics within the ICH guideline: Disease Similarity Sub-group; Modeling and Simulation Subgroup; Statistics Subgroup

Jun. 2018 ongoing Develop key items for inclusion in the guideline using concept paper as basis

The EWG agreed that the concept paper should be used as the basis for the guideline. Therefore, the EWG is using the concept paper as the framework for the purposes of beginning the outline for the guideline. The EWG is continuing to use these key terms in the development of each subsection

Nov. 2018 Jan. 2019 Identification of EWG Subgroup Subject Matter Experts (SMEs)

Each Subgroup lead will review list of SMEs nominated by E11A member groups and vote on a list of SMEs to serve as proposed by subgroup leads. This work was completed in January 2019.

Nov. 2018 ongoing Refinement and initial drafting of E11A guideline

Each subgroup will meet via conference call to begin work to refine the table of contents outline and begin drafting of specific sections of the guideline

Nov. 2018 Ongoing Review progress of document drafting

E11A will meet via montly conference call to review ongoing work of each subgroup.

May 2019 Jun. 2019 Preparation of presentations for face to face meeting

Each subgroup will provide an update and presentation on work accomplished to date

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ICH E14/S7B IWG Work Plan 20 February 2019

Topic Adoption date: 15 November 2018

Rapporteur: Dr. David Strauss - FDA, United States

Regulatory Chair: Dr. Kaori Shinagawa - MHLW/PMDA, Japan

Last Face-to-Face Meeting: Charlotte, NC, USA – November 2018

1. Key milestones



Dec. 2015 Finalized E14 Q&A regarding concentration-QTc analysis as an alternative analysis endpoint for QTc evaluation.

Dec. 2017 Publication of a white paper article to describe in more detail the steps involved in appropriate concentration-QTc analysis. (https://doi.org/10.1007/s10928-017-9558-5)

June 2018 A recommendation (a concept paper proposed through FDA) to ICH Assembly to reconstitute a WG at this time for the ICH E14 / S7B topic for clarification of the ICH S7B guideline through Q&As.

Aug. 2018 Revised concept paper for submission to the MC.

Nov. 2018 E14/S7B Discussion Group (DG) met in person and revised the concept paper to develop Q&As to both ICH S7B and E14. The concept paper describes a two-stage approach where Q&As will be written for both S7B and E14 in each stage. The concept paper was endorsed by the ICH Assembly and an Implementation Working Group (IWG) was formed.



June 2020 Steps 3 and 4 for first stage Q&As for ICH S7B and E14

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Beginning date


Nov. 2018 Nov. 2018 Create Concept Paper for MC and Assembly

Create Concept Paper regarding updating ICH E14 and S7B with Q&As. Develop work plan.

Nov. 2018 Nov. 2018 Finalize Concept Paper and work plan for IWG

Finalize a detailed plan on the timelines to write the proposed Q&As for S7B and E14.

Dec. 2018 June 2019 Scope first stage Q&As for S7B and E14 and develop draft text

In regular teleconferences discuss scope and detail of potential Q&As for ICH S7B and E14.

Dec. 2018 Jan. 2019 Establish six sub-groups to discuss specific topics and draft Q&As

Establish four sub-groups to draft stage 1 Q&As (Best practices for in vitro assay; Considerations for S7B in vivo core battery assay; Principles for proarrhythmia models; Integrated risk assessment that combines S7B & E14). Establish two sub-groups to discuss related topics (Additional drugs/data required for advancing Stage 2; Large molecule threshold)

June 2019 June 2019 Meet face-to-face at ICH Meeting

Discuss the potential Q&As on best practices for ICH S7B assays, and criteria for robust proarrhythmia prediction model. Discuss the potential Q&As for E14 in clinical implementation scenarios.

June 2019 June 2020 Finalize first stage Q&As for S7B and E14

In regular teleconferences draft the Q&A text in preparation for the face-to-face meeting and Q&A finalization.

June 2020 June 2020 Meet face-to-face at ICH Meeting

Finalize first stage Q&As.

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Jan. 2020 June 2020 Discuss potential second stage Q&As for S7B and E14 and generate any data needed

In regular teleconferences discuss the potential second stage Q&As focusing on data needs and gaps. In face-to-face meetings discuss data needs and timelines. A detailed timeline to finalize Q&As will be developed.

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ICH E17 IWG Work Plan 04 February 2019

Topic Adoption date: February 2018

Rapporteur: Dr. Kristina Dunder - EC, Europe

Regulatory Chair: Mr. Yasuto Otsubo - MHLW/PMDA, Japan


1. Key milestones



Feb. 2018 Concept Paper endorsement

Nov. 2018 Face to face meeting in Charlotte. Drafting of training material consisting of 7 separate modules reflecting different parts of the E17 guideline



January – May 2019

Monthly teleconferences; updates and finalization of training materials

Jun. 2019 Face to face meeting in Amsterdam to finalize training modules

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Beginning date


Mar. 2018 Mar. 2018 Establishment of IWG Nominate and assign IWG members

Mar. 2018 Nov. 2018 Web-conference or teleconference

Discuss contents of training materials

Nov. 2018 Nov. 2018 Face-to-face IWG Meeting

Finalize first set of training materials

Jan. 2019 May. 2019 Finalization of draft training material

Jun. 2019 Jun. 2019 Finalization, Editing and Publication

Editing of some of the modules at the FDA studios and publication of training materials on ICH website.

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ICH M2 EWG Work Plan February 01, 2019

Topic Adoption date: 1994

Co-Rapporteurs: Ms. Mary Ann Slack - FDA, United States Dr. Mihoko Okada - MHLW/PMDA, Japan

Regulatory Chair: Dr. Stephan Jaermann - Swissmedic, Switzerland


1. Key milestones



June 2018 The M2-identified Clinical electronic Structured Harmonized Protocol (CeSHarP) proposal was accepted as a new ICH topic.

June 2018 The M2-identified Common Clinical Trial Submission (eCCTS) was finalized and presented to the MC and assembly. WSMI submitted it as an ICH new topic proposal

Nov. 2018 Met with HL7 leadership to discuss HL7 standards portfolio strategy and FHIR growth to understand implications to ICH adopted standards. Reviewed material from HL7 CTO regarding FHIR and FHIR uptake.

Dec. 2018 Implement ICH internal terminology list management process

Dec. 2018 TMF/eTMF opportunity proposal was submitted by JPMA

Dec. 2018 Defined and confirmed Liaison approach with ISO TC215 WG6

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March 2019 Joint meeting with M8 to discuss implications HL7 FHIR and potential paths forward for eCTD.

April-May 2019

Revised draft white paper on the potential impacts and benefits of the HL7 FHIR standard for ICH initiatives

June 2019 Face to Face working meeting with HL7 CTO on plan for ICH-adopted HL7 V3 messages potential transition to FHIR, as well as considerations for new work

June 2019 Present considerations to MC regarding new standards and potential future transition of existing ICH adopted HL7 v3 standards to HL7 FHIR standard.

June 2019 Identify project opportunity for MC and Assembly review

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(note – periodic administrative activities such as SDO liaison activities are not included)

Beginning date End date Task / Activity Details

Project Opportunity Proposal

Oct 2018 May 2019 Assess HL7 FHIR implications for ICH

Based on knowledge gained to date from face to face interactions with HL7, available material and experiences, refine white paper on the potential impacts and benefits of HL7 FHIR for ICH implications, and draft considerations for existing and future ICH exchange standards.

Oct 2018 June 2019 Validate FHIR assumptions and recommendations

Work with HL7 CTO to validate assumptions made in the white paper, refine considerations and potential migration strategy, and address more specific questions regarding any transition.

Apr. 2018 Jun. 2019 Develop opportunity proposals

Develop a project opportunity proposal on standardized quality data for internal discussion and presentation of the concept to the MC.

May 2019 May 2019 Evaluate new ICH topics for technical risks and opportunities – stage 1

Talk with topic experts in each EWG at Step 1 to explore potential technological risks or opportunities

May 2019 June 2019 Evaluate ICH topics for technical risks and opportunities – stage 2

Review Step 3-4 documents for technical risks and opportunities; aggregate and discuss at next F2F meeting; discuss findings with EWG Rapporteurs

May 2019 June 2019 Execute working relation and discuss technical specification development with the CeSHarP EWG

Discuss working arrangements and plan for the development of a technical specification with the CeSHarP EWG

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ESTRI Recommendation

Jan 2019 June 2019 Update M2 web content

Review, revise and organize M2 and ESTRI web content for usability and currency

Supportive Activities

Sep. 2018 Jun. 2019 Implement SLU with E2B

Confirm jointly developed Service Level Understanding (SLU) with E2B for terminology list management. Discussion with E2B Co-Rapporteurs

Aug. 2018 Standard practice for technical artifacts used

Develop a standard practice for managing and maintaining technical artifacts used to support standards, such as EDQM controlled vocabulary extraction script for E2B(r3) Deferred until EMA transition is competed

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ICH M7 (R2) Maintenance IWG/EWG Work Plan February 01, 2019

Topic Adoption date: June 2017

Rapporteur: Dr. Masamitsu Honma – MHLW/PMDA, Japan



1. Key milestones



Jun. 2014 ICH-M7 was issued as Step4.

Mar. 2017 ICH-M7 (R1) was issued as Step 4. It contains Appendix 3 (Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes).

Jul. 2018 The concept paper of ICH-M7 (R2) is proposed; Maintenance of ICH-M7 with the 2nd addendum (application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes) and Q&A topics proposed based on experience through implementation of ICH-M7.

Nov. 2018 The Face-to Face meeting of ICH-M7 (R2) was held in Charlotte.

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Jun. 2019 Revising M7 main document, and drafting guideline of addendum and Q&A

Nov. 2019 Step 1 and 2a/b, revised M7 document, draft guideline of addendum and Q&A

Jun. 2020 Step 3 Public Consultation.

Nov 2020 Discussions of public comments, if feasible, reach Step 4


Beginning date


Nov. 2018 Jan. 2019 Listing items for the 2nd addendum and the Q&A by E-mail.

For the development of the 2nd addendum, additional compounds can be submitted. For the development of the Q&A, additional questions can be submitted.

Feb. 2019 Feb. 2019 Whole EWG WebEx

Discussion about a list of compounds in the 2nd addendum and items in the Q&A.

Mar. 2019 Mar. 2019 Safety EWG WebEx

Discussion about safety issues in the Q&A.

Mar. 2019 Mar. 2019 Quality EWG WebEx

Discussion about quality issues in the Q&A.

Apr. 2019 Apr. 2019 Whole EWG WebEx

Discussion about a list of compounds in the 2nd addendum and confirmation of the progress of Q&A documents.

May. 2019 May. 2019 Safety EWG WebEx

Discussion about safety issues in the Q&A (continued).

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May. 2019 May. 2019 Quality EWG WebEx

Discussion about quality issues in the Q&A (continued).

May. 2019 May. 2019 Whole EWG WebEx

Discussion about a list of compounds in the 2nd addendum and confirmation of the progress of Q&A documents (continued).

Jun. 2019 Jun. 2019 EWG Face-to Face meeting / Drafting the 2nd addendum and Q&A.

Drafting the 2nd addendum and Q&A document. Finalizing M7 (R2) main text after confirmation in EWG.

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ICH M9 EWG Work Plan 11 February 2019

Topic Adoption date: 14 June 2016

Rapporteur: Dr. Jan Welink – EC, Europe

Regulatory Chair: Dr. Paul Seo – FDA, United States


1. Key milestones



Nov. 2016 Concept Paper endorsement

Nov. 2016 Business Plan endorsement

Jun. 2018 Reaching Step 1 on document

Jun. 2018 Reaching Step 2a/b on document



Jul. 2018 Public consultation period

Feb. 2019 Ending public consultation period

Jun. 2019 Steps 3 and 4 adoption of the Final Guideline

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Beginning date


Feb. 2019 Feb. 2019 Review of comments received during public consultation

Compilation of all the comments

Mar. 2019 Mar. 2019 Teleconference Discussion on the comments received during public consultation. Incorporation of the comments in the guideline.

Apr. 2019 Apr. 2019 Teleconference Discussion on the comments received during public consultation. Incorporation of the comments in the guideline.

May. 2019 May. 2019 Teleconference Discussion on the comments received during public consultation. Update guideline.

Jun. 2019 Jun. 2019 Face to face meeting Amsterdam if needed and Adoption of the Final Guideline

Finalisation of the guideline.

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ICH M11 EWG Work Plan February 01, 2019


Rapporteur: Ms. Vivian Combs - PhRMA

Regulatory Chair: Dr. Ron Fitzmartin - FDA, United States


1. Key milestones



Jun. 2018 Concept Paper Outline endorsed at Kobe meeting

Sep. 2018 Establishment of Informal Working Group

Nov. 2018 Endorsement of Final Concept Paper, Business Plan, and Work Plan

Nov. 2018 Establishment of formal Expert Working Group (EWG)



Jun. 2020 Step 1 Sign-off of Technical Document (guideline, template, technical specification)

Jul. 2020 Step 2a / 2b endorsement of Technical Document

Jul. 2021 Step 3 End of Public Consultation Period

Nov. 2021 Step 3 Signoff of Technical Document

Nov. 2021 Step 4 Adoption of Technical Document

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Beginning date


Feb. 2019 Mar. 2019 Refine Table of Contents of the template

Review and refine draft TOC as proposed by working subgroup

Feb. 2019 May. 2019 Define Strategy for Development of Technical Specification

Consult informally with representatives from the M2 EWG to define goals, explore options, and team approach to development of a technical specification

Feb. 2019 Mar 2019 Define Strategy for Coordination with other EWG’s

Complete assessment of areas/points of overlap with other ICH EWGs and determine contact expert names, type and timing of connection needed, and team members responsible for this informal connectivity.

Mar. 2019 Apr. 2019 Establish Content Development Strategy

Prioritize sections for content development; identify relevant reference or source materials by section; assign preparation of first drafts by section among team volunteers; establish timeline for content development and review

Mar 2019 May 2019 Make contact with other EWGs as defined in Coordination Strategy

Establish contact with other EWGs, as appropriate, to ensure alignment; confirm whether subsequent or periodic check-ins are necessary and discuss appropriate timing

Apr. 2019 May. 2019 Preliminary Content Development- draft template content

Preparation of draft template content; conventions and guiding principles will be captured as they are developed

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ICH Q2(R2)/Q14 EWG Work Plan 15 February 2019 Topic Adoption date: November 2018

Rapporteur: Dr. Yukio Hiyama - MHLW/PMDA, Japan

Regulatory Chair: Dr. David Keire - FDA, United States


1. Key milestones



Nov. 2018 Concept Paper and Business Plan endorsements



June 2019 First draft

June 2020 Step 1 sign-off, Step2a/b endorsement

Q4 2020 Public consultation period

Q2 2021 Step 3 sign-off, Step 4 adoption by regulatory Members of the Assembly


Beginning date


Nov. 2018 May 2019 10 EWG meetings via teleconference

Write structured texts for Q2(R2) and Q14. Identify key issues. This will be done mostly by the sub team communication.

Jan.2019 May 2019 Communication with related ICH topics, i.e. Q12 and Q13

Make sure that Q2(R2)/Q14 is consistent with the ongoing related topics.

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ICH Q3D(R1/R2) EWG Work Plan 01 February 2019

Topic Adoption date: October 2009 (Maintenance for Cutaneous and Transdermal Routes approved September 2016)

Rapporteur: Dr. Timothy McGovern - FDA, United States


Last Face-to-Face Meeting: Geneva, Switzerland - November 2017

1. Key milestones


Past

completion date Milestone

Q1 2018 Achieve consensus on revision to Cadmium Inhalation PDE

Q3 2018 Publish Step 2 version for public comment on Cadmium Inhalation PDE

Q4 2018 Receive and review public comments on Step 2 document.



Q1 2019 Finalize Step 3/4 revision to Q3D(R1) - Cadmium Inhalation PDE following review of public comments

Q2 2019 Finalize Step 2 Q3D(R2) cutaneous and transdermal PDEs document

Publish for public comment Step 2 cutaneous and transdermal PDEs document

Q4 2019 Review public comments, revise document and finalize Step 4 document for Q3D(R2) cutaneous and transdermal PDEs

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Beginning date


Nov. 2017 July 2019 EWG holds monthly teleconferences; subgroups work on key action items identified at 2017 F2F meeting

Sub-groups address key issues including bioavailability assumptions; potential skin toxicity; applicability of limit for nickel; treatment of platinoids. Report back on progress at monthly calls. Initiate drafting of document.

Jun. 2018

Finalize PDE revision to Cadmium Inhalation PDE

Sign off on Step 2 document; prepare for release for public comment

Sep. 2018 Jan. 2019 Review public comments on Cadmium PDE revision

Gain agreement on Step 3/4 version

Feb. 2019 Finalize Cadmium Inhalation PDE revision

July 2019 Finalize Step 2 PDEs for cutaneous and transdermal route of administration.

Initiate procedure to publish for public comment.

PDEs to be published for public comment.

August 2019 November 2019

Step 3 Internal/external consultation in ICH regions for cutaneous and transdermal route of administration

Dec. 2019 Mar. 2020 EWG telecon/e-mail consultation

Reviewing and resolving comments received from consultation process; preparing Step 3/4 document

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April 2020 Step 3 signoff Postal signoff Step 3 by the Regulatory Experts.

May 2020 Step 4 Adoption by the Regulatory Members of the Assembly.

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ICH Q12 EWG Work Plan February 25, 2019

Topic Adoption date: September 2014

Rapporteur: Ms. Ashley Boam – FDA, United States

Regulatory Chair: Ms. Nanna Kruse – EC, Europe

Last Face-to-Face Meeting: Tokyo, Japan, February 2019 (Q12 interim meeting)

1. Key milestones



Sep. 2014 Concept Paper endorsement

Jun. 2017 Step 1 for Q12 Technical Document, consisting of Core Guideline and associated Annex

Nov. 2017 Steps 2a and 2b reached

Dec. 2018 End of public consultation period



Jun. 2019 Step 3 Experts Sign-off

Second half 2019 Step 4 adoption

Second half 2019 Initiation of training activities

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Beginning date


Mar. 2019 Mar. 2019 EWG meeting via teleconference and exchange of proposed text revisions via email

Continue discussion of any significant public comments not addressed at interim F2F meeting, discuss proposed text revisions developed by subgroups and plans for training.

Mar. 2019 Apr. 2019 Continue to exchange proposed text revisions via email

Where possible, agree upon revised text to address minor comments.

May. 2019 May. 2019 EWG meeting via teleconference to discuss proposed text revisions and plan agenda for June F2F meeting

Continue discussion of proposed revisions developed by subgroups. Plan agenda for June F2F meeting

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ICH Q13 EWG Work Plan February 21, 2019


Rapporteur: Dr. Sau (Larry) Lee – FDA, United States

Regulatory Chair: Dr. Yoshihiro Matsuda - MHLW/PMDA, Japan


1. Key milestones



Nov. 2018 Concept Paper and Business Plan Endorsement

Nov. 2018 Initiation of consensus building



Jun. 2020 Step 1 sign-off and Step2 a/b endorsement, and initiate public consultation

Nov. 2021 Step3 sign-off and Step 4 adoption of final guideline

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Beginning date


Nov. 2018 May. 2019 Multiple EWG Meetings via Teleconference

Develop outline for technical document; initiate drafting process; identify sub-teams if required; identify potential sites for visits; discuss plans for face-to-face meeting

Jun. 2019 Jun. 2019 Face-to-Face EWG Meeting

Continue progress on drafting of technical document and consensus building; presentations on technical approaches/perspectives

Jun. 2019 Nov. 2019 Multiple EWG Meetings via Teleconference

Share and revise draft text for technical document; sub-team reports, if appropriate; discuss plans for next face-to-face meeting

Nov. 2019 Nov. 2019 Face-to-Face EWG Meeting

Continue progress on drafting of technical document and consensus building; discuss identified regional and/or technical concerns identified between face-to-face meetings

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ICH S5(R3) EWG Work Plan 23 January 2019

Topic Adoption date: April 2014

Rapporteur: Dr. Günter Waxenecker - EC, Europe


Last Face-to-Face Meeting: Charlotte, USA, November 2018

1. Key milestones



Mar. 2015 Topic endorsed by the ICH Steering Committee.

Jul. 2017 Step 1 sign-off; Experts sign-off to confirm all Members agreement with the document.

Aug. 2017 Step 2a/b document sign-off; Plan for a ≤ 6-month public review

Oct. 2017 Explanatory slides agreed by EWG members went online

March 2018 Public comment period closed



Q1 2019 Revised document ready for internal stakeholder review.

Jun. 2019 Face to Face meeting to discuss comments from internal stakeholders and edit Step 2a/b document.

Nov. 2019 Step 3 experts sign-off / Step 4 adoption: Face-to-face meeting to finalize Step 3, sign-off and to request adoption at Step 4 of the ICH process.

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Beginning date


Sep. 2017 Nov. 2019 ICH S5(R3) EWG Teleconferences

Initiate review of the ICH Reference compounds currently in the list and those submitted through the public notification, as they become available, to double check data, ensure accessibility to source data and identify data gaps. Formation of an ICH S5(R3) EWG subgroup to work on details.

Nov. 2018 December 2018

Revise Step 2a/b document

EWG agreed on reorganization and performed line by line editing of revised step 2a/b document.

January 2019 May 2019 Monthly ICH S5(R3) EWG and regional Teleconferences

Discuss progress of revisions and internal stakeholder comments.

November 2018

March 2019 Draft distributed to internal stakeholders

A revised draft of the Step 2a/b document will be provided to internal stakeholders for comment.

November 2018

March 2019 Concept paper for maintenance procedure submitted

EWG will provide the concept paper for the maintenance procedure of the annex to the MC.

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ICH S11 EWG Work Plan 01 February 2019

Topic Adoption date: 10 November 2014

Rapporteur: Dr. Paul C. Brown - FDA, United States

Regulatory Chair: Dr. Jan Willem van der Laan - EC, Europe


1. Key milestones



Jun. 2018 EWG agreement on Step 1 document

Sep. 2018 Endorsement by the Members/Regulatory Members of the ICH Assembly under Step 2a/b and release for public consultation



Mar-Jun 2019 Monthly TCs to review and discuss comments

Jun. 2019 Face-to-face meeting to discuss comments and revise document

Jun-Nov. 2019 Monthly TCs to prepare final document

Nov. 2019 Face-to-face meeting to finalize Step 4 Guideline

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Beginning date


Mar. 2019 Apr. 2019 Collation and sharing of submitted comments

Collate and organize comments. Remove redundant comments. Share comments electronically.

Mar. 2019 Jun. 2019 Review comments. Begin editing document.

Detailed review of all comments. Teleconferences to discuss comments, prioritization of comments and possible edits. Prepare for June 2019 meeting.

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WGs NOT Meeting in Amsterdam

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ICH E19 EWG Work Plan 31 January 2019

Topic Adoption date: September 2016

Rapporteur: Dr. Mary Thanh Hai - FDA, United States

Regulatory Chair: Dr. Peter Mol - EC, Europe


1. Key milestones



Jul. 2017 Final concept paper endorsed by ICH Management Committee



Feb. 2019 Finalise the technical document and Step 1 Experts sign-off

Mar. 2019 Step 2a/b Endorsement of the Draft Guideline

Jun. 2021 Finalise Step 3/Step 4 Adoption of the Final Guideline

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Beginning date


Nov. 2017 Jun. 2018 E-mail consultation within EWG

Tasks distributed among members (action plan) as identified during the face to face meeting

Continue to work on technical document

Feb. 2018 Apr. 2018 Teleconference Discuss draft of the technical document

Jun. 2018

Jun. 2018 Face-to-Face meeting (Kobe, Japan)

Face-to-Face meeting to discuss resolve issues and draft as a group (achieve close to a final version of the technical document)

Jun. 2018 Aug. 2018 EWG Editorial team to edit technical document

Document clean-up and edit to create a consistent style and format

Aug. 2018 Sept. 2018 E-mail consultation within EWG


Generate high-level comments on the draft technical document

Sept. 2018 Sept. 2018 Teleconference via WebEx

Discuss comments generated to the draft technical document

Sep. 2018 Nov. 2018 E-mail consultation within EWG


Schedule teleconference(s) as needed

Nov. 2018

Nov. 2018 Face-to-face meeting (Charlotte, NC, USA)

Complete near draft final technical document

Nov. 2018 Jan. 2019 E-mail and Teleconference via WebEx consultation within EWG

Monthly teleconferences , e-mail, and document sharing to revise draft technical document

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Feb. 2019 Feb. 2019 Step 1 expert sign-off Finalise technical document and electronic Step 1 Experts sign-off

Feb. 2019 Mar. 2019 E-mail consultation within EWG and Assembly

Electronic Step 2a/b Endorsement of Draft Guideline by Assembly Members and by Assembly Regulatory Members

Apr. 2019 Apr. 2019 Start of Step 3- Regional public comment period

Start of regional public comments period

range between 30 days to 6 months depending on regional requirements

Oct. 2019 Oct. 2019 End of regional public comment period

Receive public comments from all regions

Review regional public comments

Nov. 2019 Nov. 2019 Face-to-face meeting (TBD)

Revise technical document to address public comments

Jun. 2020 Jun. 2020 Face-to-face meeting (TBD)


Nov. 2020 Nov. 2020 Face-to-face meeting (TBD)


Jun. 2021 Jun. 2021 Face-to-face meeting (TBD)

Finalise Step 3/Step 4 Adoption

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ICH M1 PtC EWG/IWG Work Plan January 18, 2019

Topic Adoption date: 1999 (Approximately)

This working group develops and maintains the MedDRA Points to consider (PtC) documents. As new areas of MedDRA are developed, the documents require refinement and updating twice a year in line with new MedDRA versions. This working group has also developed a Companion Document. The first version, released in June 2018, provides additional guidance on high level topics pertaining to the use of MedDRA (e.g. data quality issues and detailed examples for medication errors). Examples for product quality issues are planned for a later version. This WG also provides guidance on ICH MedDRA initiatives when requested by the MedDRA Management Committee.

Rapporteur: Dr. Christina Winter - EFPIA

Regulatory Chair: Dr. Sonja Brajovic - FDA, United States

Last Face-to-Face Meeting: Geneva, Switzerland, November 2017

1. Key milestones



Jun. 2018 Release of ‘Companion Document’ version 1.0

Sep. 2018 Release of “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents (updated for MedDRA Version 21.1)

Nov. 2018 Release of Condensed Versions of “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” into all MedDRA languages (except English and Japanese)

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Feb. 2019 Collation of user comments, discussion of potential changes to the ‘Companion document’

Mar. 2019 Release of “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents (updated for MedDRA Version 22.0)

Sep. 2019 Release of “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents (updated for MedDRA Version 22.1)


Beginning date


Jul. 2018 Feb. 2019 “MedDRA Points to Consider, Companion document”

Collation of user comments, discussion of potential changes to the ‘Companion document’

Sep. 2018 Feb. 2019 “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents

Discuss user feedback and update both documents for MedDRA version 22.0 (planned release Mar2019).

Mar. 2019 Aug. 2019 “MedDRA Term Selection: Points to Consider” and “MedDRA Data Retrieval and Presentation: Points to Consider” documents

Discuss user feedback and update both documents for MedDRA version 22.1 (planned release Sep2019).

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ICH M8 EWG/IWG Work Plan 14 January 2019


Rapporteur: Mr. Mark Gray – FDA, United States

Regulatory Chair: Ms. Kristiina Puusaari – EC, Europe

Last Face-to-Face Meeting: Kobe, Japan – June 2018

1. Key milestones



Jun. 2018 Step 4 eCTD v3 Questions and Answers and Specification Change Request Document v1.31

Jun. 2018 Step 4 eCTD v4 Implementation Package v1.3

Jun. 2018 Step 4 Specification for Submission Formats for CTD v1.2

Jun. 2018 Step 4 eCTD v4 Questions and Answers and Specification Change Request Document v1.2



Jun. 2019

Step 4 eCTD v3 Questions and Answers and Specification Change Request Document v1.32 (if Change Requests are received)

Jun. 2019

Step 4 eCTD v4 Questions and Answers and Specification Change Request Document v1.3 (if Change Requests are received)

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Beginning date


Nov. 2018 Jun. 2019 Update v3.2.2 v1.32 and v4.0 Q&A to v1.3

• Discuss change requests (if any) • Update and agree to the Q&As (if

needed)

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ICH M10 EWG Work Plan January 30, 2019

Topic Adoption date: June 2016

Rapporteur: Dr. Akiko Ishii-Watabe - MHLW/PMDA, Japan

Regulatory Chair: Dr. Brian Booth - FDA, United States


1. Key milestones



Oct. 2016 Concept Paper endorsement

Oct. 2016 Business Plan endorsement

Jan. 23, 2019 Step1 sign-off



Feb. 2019 Step 2a, 2b endorsement

Mar. 2019 Public consultation (~Aug. 2019)

Nov. 2020 Step 3 sign-off and Step 4 adoption

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Beginning date


Mar. 2019 Aug. 2019 Public consultation period

Regional regulatory consultation of M10 draft guideline is conducted in each Regulatory Member

Sep. 2019

Sep. 2019

E mail consultations Comments obtained through the public consultation in each Member are shared within EWG members.

Oct. 2019 Oct. 2019 Teleconferences Topics to be discussed in face-to-face meeting are selected and discussed.

Nov. 2019 Nov. 2019 Face-to-Face meeting The draft guideline is revised by reflecting the comments obtained via public consultation.

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ICH Q3C(R8) EWG Work Plan 1 February 2019

Topic Adoption date: February 2017

Rapporteur: Dr. Timothy McGovern - FDA, United States


Last Face-to-Face Meeting: none (written procedure)

1. Key milestones



May 2017 Achieved consensus on three solvents develop PDEs to include tert-butanol, 2-methyltetrahydrofuran, cyclopentylmethylether.

November 2018 Finalisation of Q3C(R7) – error correction for ethylene glycol PDE.



Q1 2019 Step 2a/b Endorsement of the Draft Guideline

Q3 2019 Step 4 Adoption of the final Guideline

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Beginning date


Apr. 2019 Approval by the Assembly under Step 2

Release for public consultation

Apr. 2019 Oct. 2019 Step 3 Internal/external consultation in ICH regions

Oct. 2019 Nov. 2019 EWG telecon/e-mail consultation

Reviewing and resolving comments received from consultation process; preparing Step 3/4 document

Q4 2019 Step 3 signoff Electronic signoff Step 3 by the Regulatory Experts.

Feb. 2020 Step 4 Adoption by the Regulatory Members of the Assembly.

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ICH S1(R1) EWG Work Plan 18 February 2019

Topic Adoption date: May 2012

Rapporteur: Dr. Frank D. Sistare - PhRMA

Regulatory Chair: Dr. Jan Willem van der Laan - EC, Europe


1. Key milestones



Aug. 2013 Regulatory Notice Document (RND) posted to ICH Website, formally launching the Prospective Evaluation Period (PEP) and calling upon the pharmaceutical industry to submit 50 Carcinogenicity Assessment Documents (CADs) and Final Study Reports (FSRs).

Jan. 2016 Substantially revised RND posted to ICH Website that redefined the target to 20 Category 3 CADs/FSRs, and extending the PEP for 2 yrs and setting a milestone of Dec 2017 for the 20 Category 3 CADs

Jun. 2017 Dec. 2017 Nov. 2018

Alignment reached on interpretation of 14 FSRs/CADs and the favorable results supported initiating the drafting of an ICHS1B Addendum 48 CADs total with 24 Category 3 received, so PEP agreed to be successfully terminated. Status Report posted to the ICH Website in Feb 2018 providing a public view to the strong progress. With 14 additional to reach a total set of 28 matching FSRs/CADs we have confirmation of favorable results, and several additional topics have been raised for discussion in anticipation of preparing for step 1 in Nov 2019.



November 2019 Step 2 Guideline

November 2020 Step 4 Guideline

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Beginning date


Nov. 2018 Nov. 2019 EWG members to meet every other month by telecon. DRA members to meet separately to review all new CADs and FSRs. DRAs to draft updated PEP Status Report to ICH Website disseminating insights to evaluations of summary reports. Drafting of modifications to S1B to continue.

EWG to review progress, feedback, on CAD submissions and align on plans for meeting face-to-face in November 2019 to review regulatory member conclusions from all FSRs received and reviewed; and to continue drafting revisions to S1B and review and align on new proposed guidance that reflects the experience and value of the CADs/ FSRs during the prospective evaluation.

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ICH IQDG Work Plan

April 08, 2019


Rapporteur: Mr. Roger Nosal - PhRMA

Regulatory Chair: Ms. Nanna Abby Kruse - EC, Europe

Last Face-to-Face Meeting: NA

1. Key milestones


Past


Oct. 2018 Remit of the Informal Quality Discussion Group (IQDG)

Nov. 2018 IQDG Remit endorsement by Management Committee

Mar. 2019 First IQDG telecon


Expected future


Mar. 2019 IQDG draft Workplan

Apr. 2019 IQDG prioritization and recommendations for new ICH Guideline topic

proposals (i.e. Q5A, Extractables and Leachables (E&L), Q9,

Oligonucleotides...)

Apr. 2019 IQDG Work Plan for MC consideration

Jun. 2019 Agree IQDG Assessment Process establishing criteria to review/triage

existing ICH Q & relevant M Guidelines, ICH Guidelines in progress (Steps 1-

3) & newly proposed ICH Q topics/Guidelines.

Jun. 2019 Preliminary report to MC on:

• IQDG future vision for integration & scope ICH Quality Guidelines

• Plans for assessment & prioritization of existing ICH Quality Guidelines

that warrant possible revision, updates, annexures, clarifications, Q & A,

a potential new guideline, implementation plans &/or training in

accordance with the ICH Quality Vision.

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Oct. 2019 Assessment of any other new/revised ICH Quality topic proposals & priority

recommendations to the MC for consideration & disposition.

Nov. 2019 IQDG Status report to MC on assessment & prioritization of existing ICH

Quality guidelines that warrant possible revision, updates, annexures,

clarifications, Q & A, a potential new guideline, implementation plans &/or

training in accordance with the ICH Quality Vision

Jun. 2020 IQDG Status report to MC on assessment & prioritization of existing ICH

Quality guidelines that warrant possible revision, updates, annexures,

clarifications, Q & A, a potential new guideline, implementation plans &/or

training in accordance with the ICH Quality Vision

Nov. 2020 IQDG Recommendation & Prioritization Report on assessment of ICH Q &

relevant M Guidelines that warrant revision, updates, annexures,

clarifications, Q & A, a new potential guideline, implementation plans &/or

training in accordance with the ICH Quality Vision.


Beginning

date End

date Task / Activity Details

Feb. 2019 Feb. 2019 Inaugural Meeting • Review of Reflection Paper and

Remit

• Assess & prioritize proposals for

new ICH Q topics

• Develop list of priorities for

subsequent IQDG assessment

Feb. 2019 Mar. 2019 Draft workplan.

Teleconference to meet

and align on workplan

Align on tasks necessary to meet

milestone activities.

Mar. 2019 Apr. 2019 Submit workplan to MC

for consideration

NA

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Mar. 2019 Apr. 2019 Teleconferences –

• Agree to Process

• Advise on the newly

proposed ICH

quality topics

(Q5A, Oligonucleotide,

E&L, Q9, M4Q(R1), BE

for IR dosage forms)

• Develop process / develop

criteria to review/triage the

existing ICH Q and M Guidelines,

new guidelines under review and

newly proposed

topics/guidelines

• Consider new ICH Quality Topic

proposals envisioned under the

ICH Quality Vision that have not

been endorsed by the ICH with

the goal of assessing how the

proposal could be strengthened

for reconsideration.

• Prioritize and understand

linkages/relationships to existing

ICH Guidelines.

Apr. 2019 Apr. 2019 Provide final

recommendations for

newly proposed ICH

quality Topics

Provide the IQDG’s final

recommendations to ICH MC on the

assessment and prioritisation of newly

proposed 2018/2019 Quality topics

(Q5A, Oligonucleotide, E&L, Q9,

M4Q(R1), BE for IR dosage forms)

Apr. 2019 Jul. 2019 Teleconferences –

Assessment of ongoing

ICH quality Topics

In Step 2: M9, Q3D(R1),

In step 4: Q12, M7(R2),

Q3C(R8), Q3D(R2)

Other :

M4Q(R1), Q13-,

Q2(R2)/Q14

• Assess impact of ongoing ICH

Quality Topics on future ICH

Quality harmonization work

envisioned under the ICH Quality

Vision.

• Identify gaps: what guidelines

require further evaluation

/updating and why?

• Understand linkages/

relationships to other ICH

Guidelines.

• If relevant, suggest procedure

/mechanism to update, i.e.

Maintenance procedure

(preferred as allows opening

single chapters), Q&A,

additional training

• Update and compare activities,

prioritizations, and progress with

guideline evaluations.

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Jun. 2019 Jun. 2019 Discuss proposal for ICH

new topics process for

2019/2020 with MC

• Discuss ICH new topics process with

MC for 2019/2020, i.e. all new Q

topics should be progressed via the

mechanism of the IQDG.

Jul. 2019 Nov. 2019 Monthly

Teleconferences

Evaluate current ICH

Quality and

Multidisciplinary

Guidelines

ICH Q1 – Q11

• Assess impact of current ICH

Quality Guidelines on future ICH

Quality harmonization work (I.e.

Q12) envisioned under the ICH

Quality Vision.



/updating and why?



Guidelines.



Maintenance procedure, Q&A,

additional training

• Update and compare activities,

prioritizations, and progress

with guideline evaluations

Nov. 2019 Nov. 2019 Teleconference with

Informal Generic Drug

Discussion Group

• Provide feedback on the Informal

Generics Drug Discussion group

plan.

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Nov. 2019 Nov. 2019 If requested and

approved, attend F2F

ICH meeting.

• Provide update of IQDG

activities and progress to ICH

MC and ICH Assembly at f2f

meeting:

o Update ICH Quality vision

o Propose prioritised list of

new guidelines and

guideline updates

o Provide recommendation

to the training

subcommittee

Nov. 2019 Nov. 2020 Monthly

Teleconferences

Continue tasks to

complete assessment

and attend f2f ICH

meetings to present

final recommendations

on any proposed

revisions to ICH

Guidelines.

• Assess impact of all ICH Quality

Guidelines on future ICH Quality

harmonization work envisioned

under the ICH Quality Vision.



/updating and why?



Guidelines.



Maintenance procedure, Q&A,

additional training

• Prioritize and triage

recommendations.

• Provide update of IQDG

activities and final

recommendations to ICH MC

and ICH Assembly at f2f meeting

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