AESGP Euro OTC News

Issue 291 | April 2017

Medicines

Regulatory News

▪ EMA facilitates reporting of alleged

improprieties by whistle-blowers 6

▪ Summary of Product Characteristics (SmPC) 6

▪ EMA Policy on Publication of clinical data 7

▪ HMA 87th Meeting Highlights 7

▪ CMDh March 2017 Meeting Report 8

▪ Documents for comments 10

Pharmacovigilance ▪ Publication of updated Inclusion/exclusion

criteria for the 'IME list' 10

▪ Good Pharmacovigilance Practices (GVP) 11

▪ Periodic Safety Update Reports (PSURs) 11

▪ Report of EMA ‘Workshop on measuring

the impact of pharmacovigilance activities’

published 12

Herbal news

▪ AESGP Annual Hearing with MLWP

– 28 March 2017 12

▪ EMA HMPC March 2017 Meeting Report 13

▪ EMA HMPC Patient Leaflet template for

the preparation of herbal teas 13

▪ Final Revised EU Monograph on Aloe

published 14

▪ Documents for comments 14

▪ New Ph. Eur. Working Party on

Pyrrolizidine Alkaloids 15

Homeopathic Medicines

▪ Publication of HMPWG Report on the

Regulatory Status of Homeopathic Medicinal

Products in EU and EFTA countries 15

More information on page 3 and on www.aesgp.eu/53

Don’t miss the occasion to attend the top event of the consumer health in-

dustry! Register now !

EFSA

▪ Call for data on green tea catechins 16

▪ Call for data on Hydroxyanthracene

derivatives 16

Health Claims

▪ Authorisation of the claim related to

creatine and resistance training on muscle

strength published 17

▪ Authorisation of the claim related to

lactitol and normal bowel function

published 17

Food addtives

▪ Chlorophylls and chlorophyllins

re-evaluation - Call for scientific and

technical data launched 17

▪ EFSA opinion on the re-evaluation of

acacia gum (E 414) as food additive 18

▪ EFSA opinion on the re-evaluation of

lecithins (E322) as food additive 19

▪ Titanium dioxide - French food safety

agency opinion on oral exposure to

nanoparticles 19

Food for special medical purposes

▪ AESGP attends the ad-hoc Working

Group meeting of the Advisory Group

on the Food Chain, Animal and Plant

Health on 12 April 2017 20

Official controls

▪ New regulation published 21

Medical devices

Medical Devices Regulation

▪ European Parliament approved Council's

Position – Final text awaiting publication

in Official Journal 22

IMDRF

▪ Consultation on the second subset of the

IMDRF Adverse Event Reporting Terminology

on "cause investigation" - until 31 May 2017 22

Food

2 AESGP Euro OTC News | Issue 291

Annual Report 2016-2017

HIGHLIGHTS OF THE YEAR

The Association of the European Self-Medication Industry is

pleased to announce the publication of its new Annual Report !

...available on the AESGP website : www.aesgp.eu

3 AESGP Euro OTC News | Issue 291

Lilian Azzopardi

Nenad Pacek

Olaf Schwabe

Thomas Senderovitz

Sabine Jülicher

Max Wellan Max Orgeldinger

Self-care in a

changing world

Hilton Vienna Stadtpark

Speakers include:

Karl Broich

4 AESGP Euro OTC News | Issue 291

Brian Ager

Andy Tisman

Bernhard Url

Ralph Ahrbeck

Christa Wirthumer-Hoche Karl Pall

Birgit Schuhbauer

Briain de Buitleir Brian McNamara

Laurent Faracci

Dirk Ossenberg-Engels Chris Slager

5 AESGP Euro OTC News | Issue 291

Fuad Sawaya

Gerhard Lötsch

Gesine Meissner

Guido Rasi

Karin Kadenbach

Jurate Svarcaite

Zaïde Frias

Helena Dalli

Hubertus Cranz

Ilaria Passarani

Jacques de Haller

For detailed information on

the meeting and registration:

aesgp.eu/53

6 AESGP Euro OTC News | Issue 291

Medicines

Regulatory News

■ EMA facilitates reporting of alleged improprieties by whistle-blowers

The EMA Management Board has adopted a new ‘Policy

on EMA’s handling of information from external sources

disclosing alleged improprieties concerning EMA activi-

ties’ which came into effect on 17 March 2017, and aims

to create an environment where individuals from out-

side the Agency feel confident to raise their concerns

on improprieties – which may include allegations of de-

partures from standards of good practices that could

have an impact on the evaluation and supervision of

medicines-in their area of work. The policy helps EMA

assess these reports and co-ordinate any further investi-

gation in a structured way, while protecting the confi-

dentiality of the reporter.

■ Summary of Product Characteristics (SmPC)

The 6-year activity report (2016) of

the EMA Summary of Product Char-

acteristics Advisory Group (SmPC

AG) was published.

The Group was established in 2010,

following the last revision of the

SmPC guideline, to promote and

facilitate the application of the

SmPC guideline. It developed into a

platform of training, experience-

sharing and support for any SmPC

issues arising within the EU regula-

tory network.

An EMA survey on information on

medicines among healthcare pro-

fessionals in Europe in 2016 has

confirmed that SmPC stands out as

the regulatory document of refer-

ence on a medicine and is used by

all Healthcare Professionals. At its

September 2016 meeting, the

Healthcare Professional Working

Party has recommended optimising

the ease of use of regulatory infor-

mation. In line with this objective,

the SmPC AG proposes to maintain

its activities as described in 2015,

including acting on any recommen-

dations of the Commission report

on "Shortcomings in the SmPCs

and the package leaflet”.

The EMA has also published a list of

adopted scientific guidelines with

SmPC recommendations.

Quality assurance of SmPCs is also

an area of work for the EMA Com-

mittee on Medicinal Products for

Human Use (CHMP) which foresees

the following activities in its 2017

Work Plan:

Maintain and develop guidance

and other tools (training materi-

al, checklist, metrics or labelling

review guide) supporting SmPC

review such as those published

on the EudraSmPC webpage and

its public interface

Generate the reports of revised

processes to ensure scientific

committees' labelling review

based on the scientific assess-

ment and to the development of

metrics

Provide support and training on

any matters related to SmPC

Prepare an annual report on the

related activities

Consider the recommendations

of the upcoming Commission

report on "Shortcomings in the

SmPCs and the package leaflet"

Monitor the need of stakeholder

involvement with regard to the

product information

Support a consistent approach

in the process of defining thera-

peutic indications to ensure their

clarity for stakeholders

Continue and monitor the pilot

on the wording of the therapeu-

tic indication

This is also of relevance for the

work undertaken by the Industry

Associations Task Force (IATF) on

eProduct Information, of which

AESGP is part. Activities of the IATF

were presented at the CMDh on 19

April 2017 and at the joint Telemat-

ics Management Board- industry

meeting on 26 April 2017.

7 AESGP Euro OTC News | Issue 291

■ EMA Policy on Publication of clinical data

An update of the External guidance on the implementa-

tion of the EMA policy on the publication of clinical data

for medicinal products for human use, (‘Policy 0070’)

has been published, together with a summary of the

changes made to the previous version.

This document provides guidance to industry on practi-

cal aspects of the implementation of the Agency's poli-

cy on the publication of clinical data for medicinal prod-

ucts for human use. It covers guidance on the procedur-

al aspects of the submission of clinical reports, the

anonymisation of clinical reports and the identification

and redaction of commercially confidential information

in clinical reports. It also includes a checklist for the

'Redaction Proposal Document' package.

A Questions & Answers document on the External Guid-

ance of Policy 0070 on Clinical Data Publication (CDP) is

also available. It lists some questions that applicants/

Marketing Authorisation Holders (MAHs) may have on

the procedure for the publication of clinical data and

provides an overview of the European Medicines Agen-

cy's position on issues that are typically addressed in

discussions or meetings with applicants/MAHs. The

Q&A will be updated regularly to reflect any new guid-

ance updates during the implementation of Policy 0070.

■ HMA 87th Meeting Highlights

The Heads of Medicines Agencies (HMA) released the

highlights from their 87th

meeting held in Malta on 22-

24 February 2017 which, amongst other items, reports

on the following:

Update on the Multi-Annual Work Plan

Regarding the HMA Multi-Annual Work Plan (MAWP),

the topic of International collaboration was selected as

a key business priority for 2017 under the Maltese presi-

dency. The HMA has agreed to strengthen and promote

cooperative mechanisms to ensure that the participa-

tion in international fora is representative and that feed-

back is provided to the network and, as appropriate, to

stakeholders. Initiatives towards the convergence of

global standards are a key to facilitate timely access to

safe and effective medicines for patients worldwide.

Actions within this MAWP goal provide for the explora-

tion of mechanisms to effectively disseminate infor-

mation and input to the network of NCAs on the out-

comes of international fora, as a regular agenda point in

the HMA meetings. This will serve to coordinate HMA

views and to allow for an integrated representation in

international fora. Other actions to promote stronger

links with international regulators include fostering co-

ordinated involvement in networks outside the EU, pro-

moting convergence and harmonization of regulatory

processes with non-EU bodies in areas of common in-

terest as well as cooperation and information exchange

in the field of worldwide medicines assessment, regula-

tion, and new and post marketing authorisation.

Telematics Strategy

The eSubmission Roadmap aims at defining the way the

regulatory information on medicinal products is submit-

ted by applicants electronically and received, validated,

processed and distributed by regulatory authorities

within the Network. Implementation of the roadmap by

2020 aims at increasing efficiency through sustainable

fully end-to-end electronic processing of information,

enabling and facilitating electronic collaborative pro-

cesses and re-use of data as well as allowing infor-

mation sharing within the Network.

Outcome of the EU Clinical Trial Regulation (CTR)

Coordination group workshop

During the workshop, held on 14 February, attendees

discussed the EU portal and database progress, user

Acceptance Testing and as regards the audit, the chal-

lenges of release coinciding with the audit. Also the

functionality was discussed and the importance of mak-

ing sure inspection-related aspects are built in appropri-

ately has been stressed, together with the need to have

relevant systems on Active Pharmaceutical Ingredients

(APIs).

With regard the Voluntary Harmonisation Procedure

(VHP), the good experience for the upcoming system

! This was discussed at the EU Telematics Management Board

meeting on 26 April 2017, in which AESGP participated.

8 AESGP Euro OTC News | Issue 291

was noted. The procedure enables applicants to process

authorisations of clinical trials in several European coun-

tries simultaneously, which can reduce the time re-

quired for a multinational clinical trial to be authorised.

However, the importance of a well-established database

and well working portal functionalities was highlighted.

Discussions within the workshop on the EMA project

plan for the implementation on safety reporting and

assessment revealed large variety in status of prepared-

ness, underlining need to allocate more resources to

build up the necessary IT structure and training of as-

sessors.

Access to medicines in small EU/EEA member states

Issues of availability and access are the subject of dis-

cussion in all Member States, particularly in small coun-

tries. Causes are not always related to marketing au-

thorisation requirements and might result from short-

ages or supply chain issues or might concern products

which are authorised either centrally or nationally but

which are not marketed because of the limited number

of patients to be treated. An overview of legal tools in

place to overcome accessibility issues was provided,

particularly provisions of Directive 2001/83/EC. Malta

requested a few years ago to explore ways to improve

availability of medicines on its territory, including the

possibility of reducing the parallel distribution fees in

order to increase availability. EMA has initiated a 1 year

pilot initiative involving a fee reduction for notifications

for parallel distribution in the Maltese language. Heads

of the national competent authorities regulating medi-

cines in Europe and the EEA (NCAs) were provided with

an overview of Parallel distribution notices issued in

2016-2017 in the Maltese language.

! This issue was also subject to a session at the AESGP Conference

with the Heads of Medicines Agencies in Malta on 20-21 Febru-

ary 2017.

■ CMDh March 2017 Meeting Report

The following items from the meeting report may be

noted:

Update of Questions and Answers documents

The CMDh has agreed an update of several Questions

and Answers documents:

A new Question and Answer (Q4.20) in relation to

the submission of new or updated Certificates of

Suitability (CEPs) has been added to the Q&A-list for

the submission of variations according to Regulation

(EC) 1234/2008 (clean / track version).

The Questions and Answers on post-referral phase

(clean / track version) have been updated with re-

gard to the submission time for high quality transla-

tions following the procedure from 5 days to 7 cal-

endar days. As previously agreed in the CMDh, this

change will be introduced consistently in all CMDh

documents with the next revision of concerned doc-

uments.

Question 3 of the Q&A document on Pharmacovigi-

lance Legislation (clean / track version) has been de-

leted as considered obsolete. This is in line with the

deletion of the corresponding Q&A on variations,

which was already deleted in February.

Revision of Best Practice Guide on collaboration be-

tween Member States in relation to serious GMP

noncompliance issues

The CMDh has agreed an update of the Best Practice

Guide on collaboration between Member States in rela-

tion to serious GMP non-compliance issues. The revised

version focusses on the core tasks of the CMDh in the

process.

Updated Best Practice Guide on collaboration be-

tween Member States in relation to serious GMP non

-compliance issues (clean / track version)

Statistics

12 mutual recognition procedures (regarding 20

products) were started in February 2017, of which 2

related to non-prescription medicinal products in the

reference Member State.

92 decentralised procedures (regarding 180 prod-

ucts) were started during that period, of which 6 re-

lated to non-prescription medicines in the reference

Member State.

9 AESGP Euro OTC News | Issue 291

MRP

DCP

10 AESGP Euro OTC News | Issue 291

■ Documents for comments

Document AESGP Deadline

for comments

European Commission Notice to Applicants Volume 2C – Excipients in the labelling and package

leaflet of medicinal products for human use 28 April 2017

WHO draft “Collaborative procedure in the assessment and accelerated national registration of

pharmaceutical products approved by stringent regulatory authorities (SRAs)” 28 April 2017

EMA Reflection paper providing an overview of the current regulatory testing requirements for

medicinal products for human use and opportunities for implementation of the 3Rs 5 May 2017

EMA Concept paper on a revision of the Guideline on the investigation of drug interactions 2 June 2017

EMA Concept paper on the need for revision of note for guidance on quality of water for pharma-

ceutical use (H+V) 23 May 2017

EMA Concept Paper on revision of the guideline on the pharmaceutical quality of inhalation and

nasal products 8 June 2017

EMA Guideline on Good Clinical Practice compliance in relation to trial master file (paper and/or

electronic) for content, management, archiving, audit and inspection of clinical trials 21 June 2017

EMA Draft guideline on multiplicity issues in clinical trials 8 September 2017

EMA Guideline on equivalence studies for the demonstration of therapeutic evidence for products

that are locally applied, locally acting in the gastrointestinal tract as an addendum to the guide-

line on the clinical requirements for locally applied, locally acting products containing known con-

stituents

8 September 2017

Pharmacovigilance

■ Publication of updated Inclusion/exclusion criteria for the 'IME list'

The EudraVigilance Expert Working Group (EV-EWG) has

coordinated the development of an Important Medical

Event Terms (IME) list aiming to facilitate the classifica-

tion of suspected adverse reactions as well as aggregat-

ed data analysis and case assessment in the frame of the

day-to-day pharmacovigilance activities of stakeholders

in the European Union. The inclusion/exclusion criteria –

and the proposed additions and deletions to the up-

versioned list – were based on the official ICH definition

of seriousness and of an “important medical event.”

The IME list is intended for guidance purposes only. In-

clusion/exclusion criteria for the “Important Medical

Events” (IME) list were developed during review of the

current list for maintenance related to MedDRA Version

12.1 and have been now updated to the current version

of MedDRA. The updated important medical event terms

list (MedDRA version 20.0) has also been uploaded.

11 AESGP Euro OTC News | Issue 291

■ Good Pharmacovigilance Practices (GVP)

The following Guidelines on Good

pharmacovigilance practices (GVP)

modules covering major pharma-

covigilance processes have been

updated:

Guideline on good pharmacovigi-

lance practices: Module II – Phar-

macovigilance system master file

(Rev. 2) (clean/tracked changes)

Module II revision 2 includes up-

dates in relation to outdated transi-

tionary guidance, the new Article 57

database and a few aspects to be

clarified regarding the pharmacovig-

ilance systems master file (PMSF).

Guideline on good pharmacovigi-

lance practices: Module V – Risk

management systems (Rev. 2)

(clean/tracked changes).

Module V rev. 2 on risk management

system is published as final, taking

into account the comments received

from the public consultation. AESGP

had actively led the industry endeav-

our towards the simplification of the

Risk Management Plan (RMP) re-

quirement.

The guidance is updated in parallel

to the second version of the RMP

template for initial marketing au-

thorisation applications which mar-

keting authorisation holders and

applicants can use for all RMP sub-

mission. Its use for all RMP submis-

sions becomes mandatory as of 31

March 2018. Marketing authorisation

holders and applicants may still use

the first revision of the template dur-

ing a transition period.

Comments received from public

consultation on good pharmacovigi-

lance practices (GVP): Module V –

Risk management systems (Rev. 2)

(which includes comments submit-

ted by AESGP) and Guidance on the

format of the risk management plan

(RMP) in the EU – in integrated for-

mat (EMA/PRAC/613102/2015 Rev.2)

accompanying GVP Module V Rev.2

have also been updated.

Guideline on good pharmacovigi-

lance practices: Module XVI – Risk

minimisation measures: selection

of tools and effectiveness indica-

tors (Rev. 2) (clean/tracked chang-

es)

Module XVI is published in its revi-

sion 2 to delete the description of

routine risk minimisation tools as

they are detailed in GVP Module V

and to give further clarifications on

some aspects on risk minimisation.

The Guidelines on good pharma-

covigilance practices (GVP): Intro-

ductory cover note has also been

updated to account for the above-

mentioned revisions.

■ Periodic Safety Update Reports (PSURs)

Following two years of experience with safety monitoring

of nationally authorised medicines via the single assess-

ment of periodic safety update reports (PSURs), the Euro-

pean Medicines Agency (EMA) has published the follow-

ing 2 new documents aimed at improving the safety in-

formation and benefit-risk assessment of medicines in the

context of the periodic safety update single assessment

(PSUSA):

An Explanatory note to GVP Module VII which ad-

dresses issues that have been raised by companies

during two years of running the single assessment

process. Ultimately, the explanatory note will serve as

the basis for the update of GVP Module VII, which will

eventually replace it.

An Assessors' questions and answers (Q&A) guidance

on PSUR single assessment (PSUSA) to guide assessors

throughout the evaluation process of PSURs to im-

prove standards and increase consistency.

The EMA plans to organise a joint training session in the

second quarter of 2017 for the pharmaceutical industry

and EU national competent authorities to support the

implementation of the optimised single assessment pro-

cess.

For its part, the CMDh Working Party on Pharmacovigi-

lance Procedures Worksharing prepared a new Best Prac-

tice Guide on (1) Introduction of substances/

combinations onto the EURD list and setting the initial

PSUR (periodic safety update report) DLP (data lock peri-

od) and frequency and (2) Assessment of PSURs of prod-

ucts where the EU Reference Date is not yet legally bind-

ing. It sets out the arrangements for introducing new sub-

stances and combinations into the List of European Union

Reference Dates (EURDs) and frequency of submission of

PSURs (EURD list) following a MRP/DCP procedure for a

new Marketing Authorisation (MA) and setting the initial

PSUR data lock point (DLP) and submission frequency.

This guidance applies to nationally authorised products

(NAPs) approved through MRP/DCP and will usually apply

to applications for new products submitted under Article

12 AESGP Euro OTC News | Issue 291

8(3) or new combinations submitted under Article 10b of

Directive 2001/83/EC; there may however be other in-

stances where the guidance is applicable when a sub-

stance/combination is not yet included in the EURD list. In

situations where the first PSUR submission is outside the

scope of a EU Single Assessment (PSUSA) procedure, the

Member States have agreed to review this first PSUR in an

informal work sharing procedure; this guide sets out the

arrangements for such a work sharing procedure.

The Working Party also prepared an accompanying Tem-

plate for PSUR Assessment Report.

■ Report of EMA ‘Workshop on measuring the impact of pharmacovigilance activities’ published

The Report highlights that the workshop, held on 5-6 De-

cember 2016 and attended by more than 150 partici-

pants, reinforced the clear need to measure the impact of

pharmacovigilance activities based on evidence which

allows regulators and pharmaceutical industry to refocus

resources to strengthen the current pharmacovigilance

system’s capability for most efficient public health protec-

tion. There was broad consensus that all stakeholders of

pharmacovigilance have a responsibility to contribute to

measuring the impact of regulatory decisions. All partici-

pants acknowledged that depending on the outcomes of

pharmacovigilance impact assessment the future system

needs to be flexible and adapt to change.

As a way forward a modified strategy with a more sys-

tematic public health focus was discussed. Such an ap-

proach would allow regulators to determine to what ex-

tent planned regulatory action will affect public health

outcomes and inform ongoing and future decision mak-

ing. Such approach requires closer collaboration and syn-

ergies to be leveraged amongst all stakeholders of phar-

macovigilance. As a key stakeholder pharmaceutical in-

dustry expressed its commitment to contribute and share

existing data relevant for impact research and to collabo-

rate with regulators, patients and healthcare professional

organisations, and academia to generate the evidence

needed to measure impact.

The workshop also underlined several shortcomings of

traditional pharmacovigilance processes and their contri-

bution to public health protection, e.g. regulatory and

operational challenges of survey studies measuring the

effectiveness of product-specific risk minimisation and

feasibility of post-authorisation safety studies. A number

of practical and methodological challenges of impact re-

search relate to external factors (e.g. different national

healthcare policies) which influence how regulatory

measures taken at EU level are implemented locally.

These uncertainties are yet to be addressed and integrat-

ed in future decision making processes.

The presentations given at the workshop may be found

on the event’s webpage, under the ‘Documents’ tab.

Herbal news

■ AESGP Annual Hearing with MLWP – 28 March 2017

The Working Party on European

Union Monographs and European

Union List (MLWP) welcomed

AESGP representatives for a two-

hour exchange on the following

topics:

Monographs on herbal combi-

nations

Monographs on Horse-Chestnut

seed and extract

Draft Monograph on Silybi

marianae fructus

Revision of the Monograph on

Pelargonii radix

Reflection paper on Polycyclic

Aromatic Hydrocarbons in herb-

al medicinal products/traditional

herbal medicinal products

Experience concerning Mutual

Recognition and Decentralised

Procedures for herbal medicines

Proposal for simplification of

some variations specific to herb-

al medicines / Regulatory Opti-

misation Group (ROG)

Consultation on the evaluation

of Regulation (EC) No

1924/2006 on nutrition and

health claims

13 AESGP Euro OTC News | Issue 291

■ EMA HMPC March 2017 Meeting Report

Among the items mentioned in the

meeting report, the following may

be noted:

Final European Union herbal mon-

ograph adopted by the HMPC

The final European Union herbal

monograph on ‘Species diureticae’,

was adopted by the HMPC by major-

ity vote.

Quality Drafting Group (Q DG)

The Q DG informed that they, at

their February 2017 meeting:

adopted a proposal for establish-

ment of Ph. Eur. monographs for

substances assessed by HMPC

without a Ph. Eur. quality stand-

ard so far. The proposal will be

submitted to EDQM.

continued the detailed review of

the herbal specification guideline.

compiled comments on a draft

WHO guideline on Good Herbal

Processing Practice which had

been shared with HMPC and EMA

manufacturing and quality com-

pliance before submission to

WHO. Finally, other coordination

activities with EDQM and QWP

had been discussed as well as the

finalisation of a draft reflection

paper on new analytical methods.

Working Party on European Union

Monographs and European Union

List (MLWP) – Report from the

March 2017 Meeting

Finalisation of monographs:

Following public consultation, the

MLWP discussed and endorsed

the final documents on Silybi

mariani fructus for peer review

and transfer to the HMPC for

possible final adoption in May

2017.

The MLWP had a first discussion

on the comments received on the

assessment of Piperis methystici

rhizoma.

New monographs:

The MLWP discussed and en-

dorsed the documents for

Fragariae folium for peer review

and possible transfer to the

HMPC in May 2017 for release for

public consultation.

The working party continued its

assessment of Malvae folium and

Malvae silvestris flos.

Revisions:

The MLWP re-discussed and en-

dorsed the revised documents for

Pelargonii radix (after public con-

sultation and HMPC request) for

peer review and transfer to the

HMPC in May 2017 for possible

final adoption.

The MLWP further discussed and

endorsed the revised documents

for Absinthii herba (without pub-

lic consultation), Echinaceae pur-

pureae radix and Vitis viniferae

folium (after public consultation)

for peer review and possible

transfer to the HMPC in May

2017 for final adoption.

The MLWP continued the system-

atic review of Menthae piperitae

aetheroleum, Sambuci flos, Ver-

basci flos, Frangulae cortex,

Rhamni purshianae cortex, Rhei

radix, Cimicifugae rhizome, Cyna-

rae folium and Valerianae radix/

Lupuli flos and had first discus-

sions on the need for revision of

monographs on Curcumae lon-

gae rhizoma and Rusci aculeati

rhizoma.

!

Note: AESGP, via WSMI, was also con-

sulted on this WHO Guideline and sub-

mitted several comments.

■ EMA HMPC Patient Leaflet template for the preparation of herbal teas

The EMA HMPC has published a

Patient Leaflet template concerning

advice on the preparation of herbal

teas as (traditional) herbal medicinal

products by end-users which was

adopted at their meeting on 20

September 2016.

The document has been prepared

for consideration by National Com-

petent Authorities and Applicants

with the purpose of proposing a

template providing instructions to

the user on the best practice for

preparing a herbal tea (by infusion,

decoction, maceration), using

standard terminology.

This paper applies to herbal medici-

nal products (HMPs)/traditional

herbal medicinal products (THMPs)

intended to be administered in the

form of herbal teas. Instant herbal

teas as defined by the European

Pharmacopoeia monograph are not

covered by this paper, because the

preparation of the instant herbal

tea in this case consists solely of

reconstitution with water.

14 AESGP Euro OTC News | Issue 291

■ Final Revised EU Monograph on Aloe published

Further to its endorsement by consensus

at the EMA HMPC November 2016 meet-

ing, the final revision of the European

Union herbal monograph on Aloe barba-

densis Mill. and on Aloe (various species,

mainly Aloe ferox Mill. and its hybrids),

folii succus siccatus has been published,

together with its supporting documents,

on the ‘Aloe barbadensis / Aloe capensis’

page, under the ‘All documents’ tab.

AESGP has carried out a detailed com-

parison of the modifications made to the

previous version. For more information,

please contact us at:

AESGP-Medicines@aesgp.eu

■ Documents for comments

Document AESGP Deadline

for comments

EMA HMPC Draft revised European Union herbal monograph on Mentha x piperita L., folium 2 May 2017

EMA HMPC Draft European Union herbal monograph on Ribes nigrum L., folium 10 May 2017

EMA HMPC Draft public statement on Glycine max (L.) Merr., semen 10 May 2017

WHO Revised Draft Guidelines on good herbal processing practices (GHPP) for herbal medicines 12 May 2017

EMA HMPC Call for Data on herbal tea combinations traditionally used in the following therapeu-

tic areas:

‘nervous tension and to aid sleep’ (‘Species sedativae’)

‘loss of appetite’ (‘Species amarae’)

‘digestive disorders’ (‘Species digestivae or Species stomachicae’)

17 May 2017

EMA HMPC draft European Union herbal monograph on Melilotus officinalis (L.) Lam., herba

(Rev.1) 23 June 2017

EMA HMPC draft European Union herbal monograph on Arctostaphylos uva-ursi (L.) Spreng., foli-

um (Rev.2) 23 June 2017

15 AESGP Euro OTC News | Issue 291

■ New Ph. Eur. Working Party on Pyrrolizidine Alkaloids

The European Pharmacopoeia (Ph. Eur.) Commission, at

its 157th

Session on 18-19 March 2017, agreed to create

a new Working Party on Pyrrolizidine Alkaloids (PA WP)

which will be tasked with defining a general method for

testing Pyrrolizidine Alkaloids (2.8.26). This decision was

taken in response to demand by European regulators

and following reports in some Ph. Eur. member states

that herbal medicinal products, as well as food, were

found to be contaminated with traces of plants contain-

ing pyrrolizidine alkaloids.

AESGP also emphasised the urgent need for a harmo-

nised validated method at its last bilateral meeting with

the European Directorate for the Quality of Medicines &

Healthcare (EDQM) on 25 November 2016 and is thus

very pleased about this outcome.

i

Pyrrolizidine alkaloids (PAs) are nitrogen containing com-

pounds that occur naturally in plants such as common weeds.

The acute toxicity, genotoxicity and carcinogenic potential of

PAs have been known for decades. In January 2017, the

HMPC issued a Public Statement outlining the need to imple-

ment suitable testing procedures to ensure levels of pyrroliz-

idine alkaloids (PA) are controlled in line with agreed limits.

This is a key priority topic for the AESGP Committee on Herb-

al Medicinal Products.

Homeopathic Medicines

■ Publication of HMPWG Report on the Regulatory Status of Homeopathic Medicinal Products in EU

and EFTA countries

In 2016, the Heads of Medicines Agencies Homeopathic

Medicinal Products Working Group (HMA HMPWG) dis-

cussed the opportunity to share information on homeo-

pathic medicinal products in EU and EFTA countries. A

questionnaire was developed and circulated to HMPWG

members with the aim of obtaining information about

the regulatory status of homeopathic medicinal prod-

ucts in the EU and EFTA countries and the state of im-

plementation of Directive 2001/83/EC as amended by

Directive 2004/27/EC (‘the Directive’).

The report, which has been compiled from the data col-

lected and adopted by the HMPWG in February 2017,

consists of four sections:

Questions on the marketing of homeopathic and

anthroposophic medicinal products

Questions on implementation of Directive 2001/83/

EC as amended by Directive 2004/27/EC (the Di-

rective)

Questions on the specific national regulatory status

of homeopathic medicinal products

Questions on the national experience of registering/

authorising homeopathic medicinal products

Food

■ Call for data on green tea catechins

EFSA

16 AESGP Euro OTC News | Issue 291

EFSA has launched a call for data on new scientific infor-

mation as regards the use of green tea catechins.

Interested parties and stakeholders should provide

by 10/06/2017 the information described in the call for

data.

Interested parties and stakeholders are requested to

communicate by 8/05/2017 in writing by e-mail

to: fip@efsa.europa.eu their availability to submit the

requested information by the timeline specified above

or any proposal for a new deadline providing justified

reasons.

Depending on the replies received the final deadline will

be communicated to the interested parties and stake-

holders through e-mail and by updating the current call.

In order to facilitate the collaboration of all interested

parties to provide the data needed, please provide your

consent to disclose your personal data (name, e-mail

address and telephone number) to the other parties

that has expressed an interest to provide the requested

information.

AESGP Members interested in submitting the requested

information on green tea catechins listed below are re-

quested to communicate directly their availability to

EFSA by Friday 8 May 2017 in accordance with the in-

structions detailed in the call for data.

i In the context of Article 8 (2) of Regulation (EC) 1925/2006 on the

addition of vitamins and minerals and of other substances to foods,

the European Commission requested EFSA to assess the available

information on the safety of green tea catechins from all sources in

foods including preparations such as food supplements and infu-

sions (EFSA-Q-2017-00266).

EFSA has launched a call for data on new scientific infor-

mation as regards the use of hydroxyanthracene deriva-

tives.

Interested parties and stakeholders should provide

by 10/06/2017 the information described below.

Interested parties and stakeholders are requested to

communicate by 8/05/2017 in writing by e-mail

to: fip@efsa.europa.eu their availability to submit the

requested information by the timeline specified above

or any proposal for a new deadline providing justified

reasons.

Depending on the replies received the final deadline will

be communicated to the interested parties and stake-

holders through e-mail and by updating the current call.

In order to facilitate the collaboration of all interested

parties to provide the data needed, please provide your

consent to disclose your personal data (name, e-mail

address and telephone number) to the other parties

that has expressed an interest to provide the requested

information.

AESGP members interested in submitting the requested

information on hydroxyanthracene derivatives listed

below are requested to communicate directly their

availability to EFSA by Friday 8 May 2017 in accord-

ance with the instructions detailed in the call for data.

■ Call for data on Hydroxyanthracene derivatives

In the context of Article 8 (2) of Regulation (EC) 1925/2006 on the

addition of vitamins and minerals and of other substances to

foods, the European Commission requested EFSA to assess the

available information on the safety in use of hydroxyanthracene

derivatives from all sources in foods including preparations such

as food supplements and infusions. EFSA has identified rhubarb,

cassia, cascara, frangula and aloe as the main botanical sources of

hydroxyanthracene derivatives in foods.

i

17 AESGP Euro OTC News | Issue 291

Health Claims

■ Authorisation of the claim related to creatine and resistance training on muscle strength published

Following adoption by the Standing Committee in

March 2017, Commission implementing Regulation (EU)

2017/672 authorising the following health claim has

been published in EU Official Journal: Daily creatine

consumption can enhance the effect of resistance train-

ing on muscle strength in adults over the age of 55.

Information shall be provided to the consumer that:

the claim is targeting adults over the age of 55, who

are engaged in regular resistance training

the beneficial effect is obtained with a daily intake of

3 g of creatine in conjunction with resistance train-

ing, which allows an increase in the workload over

time and which should be performed at least three

times per week for several weeks, at an intensity of at

least 65 %-75 % of one repetition maximum load

The claim may be used only for foods targeting adults

over the age of 55, who are engaged in regular re-

sistance training.

■ Authorisation of the claim related to lactitol and normal bowel function published

Following adoption by the Standing Committee in

March 2017, Commission implementing Regulation (EU)

2017/676 authorising the following health claim has

been published in EU Official Journal: Lactitol contrib-

utes to normal bowel function by increasing stool fre-

quency.

The claim may be used only for food supplements

which contain 10 g of lactitol in a single daily quantified

portion. In order to bear the claim, information shall be

given to the consumer that the beneficial effect is ob-

tained by consuming 10 g of lactitol in one daily dose.

The claim shall not be used for foods targeting children.

Food additives

■ Chlorophylls and chlorophyllins re-evaluation - Call for scientific and technical data launched

The Commission has launched its

Call for scientific and technical da-

ta on the permitted food additives

chlorophylls (E 140(i)), chlorophyl-

lins (E 140(ii)), copper complexes of

chlorophylls (E 141(i)) and copper

complexes of chlorophyllins (E 141

(ii)). The details of this call are pre-

sented here.

The first two steps of the process

are as follows:

Step 1: Registration of the con-

tact details of business opera-

tors interested in submitting

data must be completed by

10/05/2017. The list of interest-

ed business operators will be

available after completion of

step 1.

Step 2: Confirmation of data

submission, deadlines and mile-

stones will then be required by

10/10/2017. The list of data that

will be submitted, deadlines and

milestones will be available after

completion of step 2.

AESGP members interested in the

use of chlorophylls (E 140(i)), chlo-

rophyllins (E 140(ii)), copper com-

plexes of chlorophylls (E 141(i))

and/or copper complexes of chlo-

rophyllins (E 141(ii)) in food supple-

ments are requested to express

their interest to AESGP at their ear-

liest convenience by Friday 21 April

2017.

NB: Unlike for iron oxides and hy-

droxides (E 172), there is no request

for data on actual use levels of chlo-

rophylls and chlorophyllins in food

therefore AESGP does not intend to

express interest under Step 1 to sub-

mit data.

The data required to address the

various issues identified by EFSA in

the re-evaluation of chlorophylls (E

140(i)), chlorophyllins (E 140(ii)),

copper complexes of chlorophylls

(E 141(i)) and copper complexes of

chlorophyllins (E 141(ii)) as food

additives are detailed here.

18 AESGP Euro OTC News | Issue 291

■ EFSA opinion on the re-evaluation of acacia gum (E 414) as food additive

EFSA published its Opinion re-evaluating the Safety of

acacia gum (E 414) as a food additive.

The Panel concluded that there is no need for a numeri-

cal ADI for acacia gum (E 414), and there is no safety

concern for the general population at the refined expo-

sure assessment of acacia gum (E 414) as a food addi-

tive.

According to the conceptual framework for the risk as-

sessment of certain food additives re-evaluated under

Commission Regulation (EU) No 257/2 010 (EFSA ANS

Panel, 2014) and given that:

the safety assessment carried out by the Panel is lim-

ited to the use and use levels in 31 out of76 food

categories in which acacia gum (E 414) is authorised

(refined exposure assessment scenario);

an indicative high refined exposure assessment up to

719 mg/kg bw per day has been calculated in tod-

dlers at the 95th percentile (non-brand loyal scenar-

io) for the general population;

an indicative high refined exposure assessment up to

626 mg/kg bw per day has been calculated in tod-

dlers at the 95th percentile in the brand loyal scenar-

io for the population consuming FSMPs;

acacia gum is unlikely to be absorbed intact and is

slightly fermented by intestinal microbiota;•sufficient

toxicity data were available;

there is no concern with respect to the genotoxicity;

no carcinogenic effects were reported in carcinogen-

icity studies in mice and rats at the doses up to 7,500

mg and 2,500 mg acacia gum/kg bw per day, respec-

tively, the highest doses tested;

oral daily intake of a large amount of acacia gum up

to 30,000 mg acacia gum/person per day

(approximately equivalent 430 mg acacia gum/kg bw

per day) for up to 18 days was well tolerated in

adults but some individuals experienced flatulence. A

dose of 53,000 mg acacia gum/person per day

(equivalent to 760 mg acacia gum/kg bw per day)

induced mild flatulence, which was considered by the

Panel as undesirable but not adverse,

Recommendations:

The Panel noted that currently detected levels of these

toxic elements (lead, cadmium, mercury and arsenic)

were far below those defined in the EC specifications for

acacia gum, and therefore, the current limits should be

lowered in order to ensure that acacia gum (E 414) as a

food additive will not be a significant source of expo-

sure to those toxic elements in food, in particular for

infants and children. The Panel also recommended that

limits for aluminium should be included in the EC

specifications.

The Panel recommended to harmonise the microbiolog-

ical specifications for polysaccharidic thickening agents,

such as gums, and to include criteria for TAMC and

TYMC into the EU specifications of acacia gum.

The Panel recommended that the oxidases and peroxi-

dases in acacia gum should be inactivated during the

manufacturing process to avoid any oxidative degrada-

tion of components in preparations to which acacia

gum is added. The Panel further recommended limits

for residual enzymatic activities and for protein content

in the EC specifications.

Due to the discrepancies observed between the data

reported from industry and the Mintel database, where

acacia gum (E 414) is labelled in more products than in

food categories for which data were reported from in-

dustry, the Panel recommended collection of data of

usage and use levels of acacia gum (E 414) in order to

perform a more realistic exposure assessment.

The data AESGP submitted in response to the call for

data (Batch 3) of March 2014 (cf. email below) have

been taken into account by EFSA in its exposure assess-

ment.

i In the EU, acacia gum has not been formally evaluated by the

Scientific Committee for Food (SCF), and therefore, no accepta-

ble daily intake (ADI) has been allocated. However, it was accept-

ed for use in weaning food (SCF, 1991). In 1999, the SCF consid-

ered ‘that the use of acacia gum/gum arabic in coatings for nu-

trient preparations containing trace elements is acceptable pro-

vided carry-over levels in infant formulae, follow-on formulae or

FSMP do not exceed 10 mg/kg’. Acacia gum was evaluated by

JECFA in 1982 and 1990 and the specifications were amended in

1998. Based on the lack of adverse effects in the available toxicity

studies, an ADI ‘not specified’ was allocated. Following the con-

ceptual framework for the risk assessment of certain food addi-

tives re-evaluated under Commission Regulation (EU)

No 257/2010, the Panel considered that adequate exposure and

toxicity data were available.

■ EFSA opinion on the re-evaluation of lecithins (E322) as food additive

EFSA has published its Opinion re-evaluating the Safety

of lecithins (E 322) as a food additive.

The Panel concluded that:

there is no need for a numerical ADI for lecithins

(E322), and there is no safety concern for the general

population from more than 1 year of age at the re-

fined exposure assessment of lecithins (E322) as a

food additive.

there is no safety concern for the exposure to the

choline from lecithins (E 322) as a food additive at

use and use levels reported by industry.

For infants and young children consuming foods for

special medical purposes, there is no safety concern

with respect to the refined exposure assessment for

the reported uses of lecithins (E 322) as a food addi-

tive and for exposure to choline resulting from these

uses of lecithins (E 322).

Recommendations:

The Panel recommended that the maximum limits for

the impurities of toxic elements (lead, mercury and arse-

nic) in the EU specification for lecithins (E 322) should

be revised in order to ensure that lecithins (E 322) as a

food additive will not be a significant source of expo-

sure to those toxic elements in food. The Panel recom-

mended that the limit for cadmium should be included

in the specifications.

The Panel noted some case reports of hypersensitivity

reactions associated with soya and egg lecithins (see

Section 3.5.7). The Panel agree with the opinion from

EFSA NDA Panel (2014) that this hypersensitivity is due

to the residual proteins in lecithins (E 322) and therefore

their content should be reduced as much as possible.

Regarding the results of the inadequate neurobehav-

ioural studies, to clarify the relevance of the data, a

study with lecithins (E 322) in compliance with the cur-

rent OECD TG 426 would be warranted.

In case the food additive lecithins (E 322) is used in in-

fant formulae and follow-on formulae supplemented

with choline or choline salts (see Section 1.2), the Panel

recommended that the intake of choline from all

sources including the use of the food additive lecithins

(E 322) via infant formulae (category 13.1.1), follow-on

formulae (category 13.1.2) or other food should be in

the order of the AIs defined by the EFSA NDA Panel

(2016).

Due to the discrepancies observed between the data

reported from industry and the Mintel database, where

lecithins (E 322) is labelled in more products than in

food categories for which data were reported from in-

dustry, the Panel recommended collection of data of

usage and use levels of lecithins (E 322) in order to per-

form a more realistic exposure assessment.

The data AESGP submitted in response to the call for

data (Batch 3) of March 2014 have been taken into ac-

count by EFSA in its exposure assessment.

Lecithins (E 322) is an authorised food additive in the EU accord-

ing to Annex II and Annex III to Regulation (EC) No 1333/2008 on

food additives, and have been previously evaluated by JECFA in

1973 and by the SCF in 1982. Among lecithins, phosphatidylcho-

line is hydrolysed in choline in the cytidine-5-diphosphate-

choline pathway in all cells of the body.

i

■ Titanium dioxide - French food safety agency opinion on oral exposure to nanoparticles

Further to the publication by the French National Insti-

tute for Agricultural Research (INRA) of a study on the

effects of oral exposure to titanium dioxide (Bettini et

al., 2017 – cf. published in January 2017), the French

food safety agency, ANSES, was mandated to issue an

opinion on oral exposure to titanium dioxide nanoparti-

cles (E 171) by:

carrying out a detailed study of the Bettini et al. pub-

lication to determine whether this sole study could

challenge the EFSA conclusions of 2016 on titanium

dioxide (cf. emails below)

as appropriate, making recommendations on priority

work streams for the characterisation and toxicity of

titanium dioxide

AESGP Euro OTC News | Issue 291 19

In its opinion, ANSES concludes that the Bettini et al.

study shows effects which had not been previously

identified – notably the potential promoter effects of

carcinogenesis of titanium dioxide. At this stage, the

findings of the Bettini et al. study do not challenge the

EFSA evaluation, but ANSES recommends that further

studies are carried out to better characterise the danger

associated with titanium dioxide.

A related press release is also available.

Food for special medical purposes

■ AESGP attends the ad-hoc Working Group meeting of the Advisory Group on the Food Chain, Animal

and Plant Health on 12 April 2017

AESGP attended the Working Group meeting of the Ad-

visory Group on the Food Chain, Animal and Plant

Health on 12 April 2017. At the meeting, the Commis-

sion presented to the stakeholders the draft Guidelines

on the Classification of Food for Special Medical Pur-

poses (FSMP).

The Commission representatives reminded that this

document had been designed to give guidance to Na-

tional Competent Authorities (NCAs) as to what is FSMP.

Food business operators are also encouraged to refer to

it prior to the placing on the market of FSMP. The text

will not be legally binding, but the Commission deemed

it important to have a common interpretation of the

definition of FSMP as there currently are discrepancies

among the Member States as to the acceptance of

FSMPs.

The draft Guidelines were scrolled through section by

section and some comments were expressed by industry

representatives around the table. However, most of

these comments were dismissed as they did not purely

concern the definition of FSMPs. The following points

raised during the discussion may be outlined:

Food business operators can currently place a prod-

uct as FSMP on the market without prior authorisa-

tion from the authorities. This document will not

modify this but the Commission representatives in-

sisted on the fact that it will help NCAs verify wheth-

er a product placed on the market as FSMP really is

FSMP. The intention of these guidelines is not to pro-

vide criteria as to whether a product is an FSMP re-

garding its composition, intended use, etc. in a scien-

tific or technical sense. It is a purely legal instrument

aiming at preventing divergent interpretations. If this

is not sufficient, an Article 3 procedure can be resort-

ed to.

Food business operators sometimes tended to reply

to an NCA which questioned the FSMP classification

that other Member States had accepted it as FSMP,

and that due to the mutual recognition principle, the

NCA also had to accept it as FSMP. But the mutual

recognition principle does not apply in these classifi-

cation cases as they do not arise from national tech-

nical rules but from harmonised EU rules.

It was clarified that if a substance is placed on the

market as a novel food ingredient for use in FSMP, it

does not automatically classify all products contain-

ing that substance as FSMPs.

The Commission representatives insisted on the fact

that FSMPs are food, therefore not medicines. Some

Member States reported that some claims which had

been rejected for food supplements were presented

again for FSMPs. It was explained that a product aim-

ing at treating a disease could not be FSMP.

The Commission representatives mentioned that to

them, FSMP was intended for feeding patients suffer-

ing from a disease/disorder/medical condition the

dietary management of which “cannot be achieved by

modification of the normal diet alone”. These patients

have to be given FSMPs, they do not choose to con-

sume them like one would choose to consume vita-

mins or minerals (in which case those would be food

supplements). Comments were expressed that the

section on the concept of “dietary management”

should clarify that some diseases may be treated by

normal diet at first, but then by FSMP (e.g. cancer).

The Commission replied that this was really a case-by

-case judgement by the authorities, but any sugges-

tion for language improvement is welcome.

AESGP Euro OTC News | Issue 291 20

21 AESGP Euro OTC News | Issue 291

It was clarified that food supplements or fortified

foods were to be considered as included in the con-

cept of “modification of the normal diet” in the sen-

tence defining FSMP as “food (…)I intended for the

exclusive or partial feeding of patients (…) whose die-

tary management cannot be achieved by modification

of the normal diet alone”. It was added that the safety

and practicability of a product must be taken into

account when assessing whether the dietary man-

agement of the patients concerned “cannot be

achieved by modification of the normal diet alone”.

Some nutrients may already be available on the mar-

ket as fortified food or food supplements; however,

patients suffering from certain diseases would need

to consume dozens of supplements to satisfy their

nutritional requirements, which is unrealistic.

The Commission specified that food business opera-

tors should have data establishing that the product

satisfies the definition of FSMP (the term “prove” as

used in section 6. Was deemed inappropriate and

will be modified).

At the end of the document, examples of products

on which there is consensus among Member States

with respect to their FSMP status are given. The

Commission representatives reckoned that it might

be useful to insert these examples in the different

sections to illustrate the points they want to explain.

This suggestion was overall appreciated as it was

mentioned that having such a list of examples at the

end of the document might be counterproductive. It

was also proposed to have very generic terms (e.g. a

disease that prevents you to…) rather than being too

precise.

A consolidated draft final version of the guidelines will

be shared for an exchange of views with Member

States. As soon as the final draft is completed, the inter-

nal process will be launched: it will go first to the Com-

mission’s legal services, and if approved, the document

will go for adoption by the Commission. It is for the mo-

ment difficult to give a precise timeline, but the Com-

mission representatives stated they hoped to have it

finished sometime around the summer, and if not, be-

fore the end of the year.

Official controls

■ New regulation published

Regulation (EU) 2017/625 of the European Parliament

and of the Council of 15 March 2017 on official controls

and other official activities performed to ensure the ap-

plication of food and feed law, rules on animal health

and welfare, plant health and plant protection products

has been published in the Official Journal (L95/1).

A specific document containing "Questions & answers"

has been published and the Commission’s webpage

related to the Official Control Regulation has been up-

dated.

Hubertus Cranz , AESGP Director General

(left), met Walter Ricciardi, President for the

Italian National Institute of Health (right), on

30 March 2017 in his offices in Rome to dis-

cuss the implementation of the new medical

device legislation and how to provide suffi-

cient capacities within notified bodies for the

assessment of substance based medical de-

vices.

Medical devices

Medical Devices Regulation

22 AESGP Euro OTC News | Issue 291

■ European Parliament approved Council's Position – Final text awaiting publication in Official Journal

On 5 April 2017, the European Par-

liament adopted in Plenary the leg-

islative resolution approving the

Council's 1st reading position on

the adoption of the Medical Devices

Regulation (MDR) without amend-

ment (early 2nd reading agree-

ment). Now that the MDR has been

formally adopted, it is to be pub-

lished in the EU Official Journal.

The publication is expected to take

place in the first week of May 2017.

The text will then:

enter into force on the 20th day

following that of its publication,

i.e. end of May 2017 (date to be

confirmed after publication).

be applicable (= actually put the

requirements into daily practice)

from the end of May 2020 (date

to be confirmed after publica-

tion).

The Commission has now a new

webpage on the MDR (and IVDR)

that has been put online just after

the vote.

All the speeches made during the

plenary debate the day before the

vote are now available here.

An update on the most relevant

changes in the regulatory frame-

work for self-care medical devices

will be provided at the AESGP 53rd

AESGP Annual Meeting in Vienna

on 1 June 2017. AESGP is also or-

ganizing a Conference in Brussels

on 10 and 11 October 2017 around

regulatory issues related to con-

sumer health products with a focus

on the implementation of the new

medical devices regulation.

IMDRF

■ Consultation on the second subset of the IMDRF Adverse Event Reporting Terminology on "cause

investigation" - until 31 May 2017

The International Medical Devices

Regulators forum (IMRDF) has

launched a public consultation on

the second subset of the IMDRF

Adverse Event (AE) Reporting Ter-

minology on "cause investigation"

which will close on 31 May 2017.

This subset will be the future Annex

B of the IMDRF guideline document

on AE reporting. The cause investi-

gation subset is structured in three

sections:

Type of investigation

Investigation results

Investigation conclusions

Should AESGP members have any

comments on the IMDRF docu-

ment, they can send them to the

IMDRF working group chair ishika-

wa-hiroshi@pmda.go.jp by the end

of the consultation period.

Please be informed that the Com-

mission indicated in relation to this

document, based on feedback and

discussions with stakeholders, that:

The term 'adverse event' when

used in the pre-market / clinical

context (see definition ISO

14155 based on the original ICH

E6(R1) document) has a more

restricted meaning focusing on

adversity happening at subject

level (patients, users etc.) as

compared to the term 'adverse

event' in the postmarket context

which has a broader scope (see

decision logic in GHTF docu-

ment GHTF/SG2/N54R8:2006).

The terms 'adverse event' (in its

broader postmarket meaning,

see above) and 'incident' can be

used interchangeably.

i The IMDRF is a voluntary group of

medical device regulators from Aus-

tralia, Brazil, Canada, China, Europe,

Japan, and the United States of Ameri-

ca, who have come together to accel-

erate international medical device

regulatory harmonization and conver-

gence.