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HMA MAWP: Achievements and Priorities for 2018 Kristin Raudsepp Director General, State Agency of Medicines, ESTONIA

EMA Managament Board member

Lead for Priority (Availability of appropriately authorised medicines) in the HMA MAWP

Co chair of the HMA/EMA Task Force of the availability of authorised medicines (TF AAM)

TOPRA Annual Human Medicines Symposium 2017

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The presentation

• HMA • EMA/HMA Strategy to 2020 • Multi Annual Work Plan (MAWP) • 2017 • 2018

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The European medicines agencies regulatory network (EU Medicines Agencies Network Strategy to 2020) • The system is based on a network of all national

medicines regulatory authorities for both human and veterinary medicines from Member States in the European Union and European Economic Area, united in the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA), working closely together in an integrated fashion, supported by other European organisations such as the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe.

• The work of the network is coordinated by EMA and the HMA.

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HMA in Tallinn, 5-7 September 2017

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Stakeholders information after HMA I in Tallinn 5-7 Sept – hma.eu

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2017 HMA priorities from EU Presidency Member States Main • International collaboration (Malta) • Competence development programme through the EU

Network Training Centre (Malta) • Availability of appropriately authorised medicines (Estonia) • Innovation and access to new medicines (Estonia)

Additional • Antimicrobial resistance (Malta) • Implementation of the telematics strategy (Malta) • Optimisation of the regulatory operations (Estonia) • Strengthen surveillance (Estonia)

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MAWP key business priorities in 2017 1. Antimicrobial resistance • Implementation of the EU Commission Action Plan,

international collaboration, WHO plan are establisehd objectives, close interaction with the EMA agreed. Awaiting Commission’s new strategy

• Develop strategy and action plan on the feasibility of cooperating to support the retention on the market of ‘old’ veterinary antimicrobials that are critically relevant for animal health by harmonising SPCs and by fostering the generation of efficacy data - preliminary discussions on SPC harmonisation have taken place. The CVMP pilot project will report at the end of 2017.

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MAWP key business priorities in 2017 2. Availability of appropriately authorised medicines 1. HMA website – http://www.hma.eu/598.html 2. HMA/EMA Task Force on Availability of authorised medicines for human and veterinary

use (Terms of Reference adopted by the HMA in Nov 2016, presented also at the EMA MB in Dec 2016)

The Task Force is composed of EMA, HMA and EC representatives as well as the Chairs of the CMDh and CMDv. The TF is co-chaired by EMA and HMA The Task Force is composed of a Steering Committee and 3 Thematic working groups 21st June 2017, 1st Teleconference of the Steering Committee, Co-Chairs: Kristin Raudsepp (HMA), Noël Wathion (EMA) Adoption of the „Composition and working methods of HMA/EMA Task Force on

Availability of Authorised Medicines for Human and Veterinary Use“ Composition of the 3 Thematic Working Groups Adoption of Work plan

• Theme 1 Marketing of authorised medicinal products • Theme 2 Supply Chain Disruption • Theme 3 Communication

Nomination of single points of contact

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MAWP key business priorities in 2017 3. Competence development programme through the EU Network Training Centre • Training events going on • Identification of priorities for training development • The veterinary sub-curricula on efficacy adopted by the

CVMP, regulatory curricula in the human area adopted by the CMDh

• A learning needs and offers framework signed with the next steps now being to make the process operational and to put in a place a lerning identification tool

• Co-operation with non-EU agencies to offer training possibilities in scientific and regulatory training events

• The EU-IN is compiling the list of innovative products and technologies calling the EMRN to develop additional competence

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MAWP key business priorities in 2017 4. Developing an efficient, effective and collaborative approach on inspections to address sustainability • Develop coordinated initiatives to allocate sufficient resources to GxP inspections, to avoid duplication of work and to share of best practices, e.g. GMPs multinational teams, training of new GxP inspectors to increase participation in GCP/GMP international inspections and continued participation in multinational inspection teams, PIC/S, including non-EU countries members without MRA

• 2017 - Clarify the actual resources of the network to perform its tasks now and in the future in order to identify the needs and opportunities of work sharing and training. The survey has been completed and the analysis of the results will be available.

• Support ICMRA initiative on GMP inspections worldwide. • Ongoing training in Pharmaceutical Inspection Academy (PIC/S) / audit

programs e.g. JAP (EU HMA) JRP (PIC/S) and the EU Network Training centre.

• The recent creation of the MRA between the EC and the US-FDA offers opportunities for enhanced collaboration, information exchange and risk-based redeployment of inspectors to manufacturing sites of higher concern in non-MRA countries

• .

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MAWP key business priorities in 2017 5. Innovation and access to new medicines 1. The HMA/EMA Joint Task Force on Big Data had a successful kick-off meeting on 6 March 2017. Work has now commenced on the mapping/characterisation of data sources: social media/M-health data; genomics; observational data; other –omics; clinical trial data and spontaneous ADRs, as well as IT tools/data management. TFwill address the use and applicability of RWD in regulatory decision. 2. the EU-IN working group now reached 23 participating authorities and it is on track with the progress on 2017 work plan. Plan for best practices towards voluntary harmonisation is being discussed. The plan for establishment of innovation contacts points/offices in more regulatory agencies is being deployed. The plan and a template for information sharing to identify emerging science and technology is being implemented with identification of innovative products and methods in development. Methodologies of horizon scanning for HMA and EMA under discussion - drafting group established. 3. CTFG has developed a traffic light system for tracking national implementation status of the CTR in the member states. 4. HMA WG on Timely Access – compassionate use, off-label use, raw data. Taking more advantage of the EU regulatory framework to facilitate the early access of innovative products – the web content on compassionate use programmes on HMA web

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MAWP key business priorities in 2017 6. International collaboration • Coordinated involvement in networks outside

EU • Harmonization of regulatory processes with non

EU bodies (ICH, VICH, GxP, PICs, ICMRA) • ICMRA 2017 • Promote cooperation and information exchange

in the field of worldwide medicines assessment, regulation, post-marketing authorisation

• 2017 – mapping of international organisations

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• Effective use of IT systems at national and EU level to maximise efficiency and minimise burdens through taking a strategic approach across the network (EU telematics, Eudravigilance go live, e-collaboration CESSP, SPOR, CT).

• Telematics strategy 2025: in order to progress further with the development of the Telematics strategy the IT DEC proposed the creation of a think-tank on the Network’s business vision. The EU TMB agreed with the proposal and the date for the workshop is scheduled in Q4 2017.

MAWP key business priorities in 2017 7. Implementation of the telematics strategy

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MAWP key business priorities in 2017 8. Optimisation of the regulatory operations • Regulatory Optimisation Group (ROG) has provided a forum for the identification

and evaluation of business process improvements in the regulatory work for NCAs, EMA and concerned stakeholders. It focuses on both quick wins and more complex challenges. Results will be presented to the HMA via business cases. CMDh and CMDv have on a regular basis stakeholders meetings (such as CMDh with the stakeholders in September 2017

• Vet regulation – experience from network to the new regulation • BEMA IV from June 2016 till Dec 2018 • HMA/EMA Task Force on adherence to time tables – HMA adopted in September

the Best practice guide on measures improving predictability of submissions/responses and adherence to communicated submission/responses deadlines

• Timely Access Subgroup: Draft document depicting all activities related to timely access, draft document regarding compassionate use programs, draft document regarding off-label, survey to MS on their experience on reviewing and reanalysis of raw data.

• The current focus of the Taskforce on Sustainability of the Network is data gathering. This initiative relates directly to the revision of the Fee Regulation: the collected data will be used to analyse the distribution of the workload for the centralized procedure between EMA and NCAs, to be able to propose a revised fee income distribution. HMA is hamonizing also the position of the NCAs on the evaluation of the existing Fee Regulation and to interact with the Rand Corporation that was contracted by the European Commission to conduct the evaluation.

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MAWP key business priorities in 2017 9. Responding to public and animal health emergencies • Develop appropriate ways to rapidly communicate and share

information between Member States in emergency cases and new diseases status, working with the incident review network.

• Coordinate resources for assessment in the event of public health emergencies - the rapid alert (RA) notification systems in place both for pharmacovigilance and quality defect/manufacturing issues.

• the Incident Review Network (IRN) was set up within the EU Regulatory Network. The IRN is a virtual network/body which provides direction/orientation in relation to incidents, in order to prevent crises. Representatives from the European Commission, the EMA and experts from the national competent authorities participate in IRN teleconferences. It is considered that the IRN/EU incident plan for human medicines is an appropriate and extremely effective mechanism for handling all types of incident.

• The concept of exchanging medicines between Member States during health crises should be further considered.

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MAWP key business priorities in 2017 10. Strengthen surveillance • Optimising the process for veterinary phVig –

workshop in 2016, reviewing the „Reflection paper for promotion of PhVig reporting“ ongoing

• Distributon channels, incl internet market – dialogue, exchange of best practices, survey launched April 2017

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MAWP key business priorities in 2017 11. Support for better use of medicine

• Working with QRD group to ensure harmonisation in order to facilitate multilingual packages

• Improved communication tools for patients and HCPs to improve use of medicines – identifying best practices, continuing the activities carried out by SCOPE in the field of communication, analyzing which new information added to the currently provided information may promote better use of medicines

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The horizon has changed

MAWP revision - Refocusing the Multi- Annual Working Program (MAWP) in connection to the BREXIT • 4 breakout sessions scheduled at HMA 1-Tallinn to re-discuss the

HMA key business priorities of the MAWP in relation to the Brexit

• Resource planning in the network • Midterm review of the HMA MAWP to follow • Further discussion at HMA II (28.-30.11) in Tallinn during the

Estonian Presidency.

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Refocusing the MAWP in connection to the BREXIT? • the HMA MAWP has 11 priorities with more than 60

actions all together. • HMA discussed the MAWP in order to agree on

potential re-focusing of the priorities, potential delay of some activities during BREXIT phase and to ensure adequate participation and engagement from all HMA NCAs in delivering on the MAWP.

• Is it possible to find out which of the 11 MAWP priorities are the most important/urgent to focus on until BREXIT and which are the less important/urgent.

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Some discussion themes

• Dominating poistions was that the adopted working plan should be followed as it was approved without any differentiation between the priorities.

• It was pointed out that most of the priorities are horizontally and vertically integrated and connected to others via activities.

• Adjustments in prioritizing might be needed after the Brexit situation is more clear and reforming the indicators might be needed. It was also discussed if Brexit should be the top priority in the MAWP, or rather it could be involved in the business continuity plan.

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Some discussion themes (2)

• 3 priorities dominating: • availability of appropriately authorised medicines, • implementation of the telematics strategy and • optimisation of the regulatory operations

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HMA priorities for 2018 from EU Presidency Member States • Bulgaria Availability of appropriately authorized medicines Innovation and access to new medicines

• Austria Availability of appropriately authorized medicines Competence development programme through the EU-NTC

Additionally, important to all of us: • Clinical trials regulation • FMD • HMA Brexit coordination group

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Conclusions

• HMA MAWP started 2016 as planned • BREXIT making its corrections, some slowdown

and changes inevitable • HMA MAWP mid-term review on its way