25 January 2018 EMA/HMPC/18658/2018 Inspections, Human Medicines Pharmacovigilance & Committees Division

Committee on Herbal Medicinal Products (HMPC) Agenda for the meeting on 29-30 January 2018

Chair: Marisa Delbò

Vice-Chair: Emiel Van Galen

29 January 2018, 14:00 – 19:00, 2F 30 January 2018, 09:00 – 13:00, 2F

Health and safety information In accordance with the Agency’s health and safety policy, delegates are to be briefed on health, safety and emergency information and procedures prior to the start of the meeting. Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. Of note, this agenda is a working document primarily designed for HMPC members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to ongoing procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006).

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Table of contents 1.

Introduction

1.1.

Welcome and declarations of interest of members, alternates and experts ............ 4

1.2.

Adoption of agenda................................................................................................. 4

1.3.

Adoption of the minutes ......................................................................................... 4

2.

European Union herbal monographs and list entries

2.1.

Report on MLWP activities ...................................................................................... 4

2.1.1.

MLWP Mandate and Rules of Procedure - revision .......................................................... 4

2.1.2.

MLWP work plan 2018 ................................................................................................ 4

2.1.3.

New substances proposed for HMPC assessment............................................................ 4

2.1.4.

Appointment of Rapporteurs and Peer-reviewers ........................................................... 5

2.1.5.

Election of MLWP Chair ............................................................................................... 5

2.1.6.

Appointment of new MLWP member ............................................................................. 5

2.1.7.

Report from the MLWP November 2017 meeting ............................................................ 5

2.2.

Revised EU herbal monographs and list entries for final adoption .......................... 5

2.2.1.

Monograph on Uvae ursi folium ................................................................................... 5

2.3.

Revised EU herbal monographs and list entries for public consultation .................. 5

2.3.1.

Monograph on Rusci aculeati rhizoma and supporting documents .................................... 5

2.3.2.

Monograph on Hyperici herba and supporting documents................................................ 5

2.4.

EU herbal monographs, list entries and public statements for final adoption ......... 6

2.5.

EU herbal monographs, list entries and public statements for adoption for release for public consultation ............................................................................................ 6

2.5.1.

Monograph on Cisti cretici folium and supporting documents – postponed to March 2018 ... 6

3.

Referral procedures

6

4.

Guidelines and guidance documents

6

4.1.

Non-clinical/clinical safety and efficacy and multidisciplinary ................................ 6

4.2.

Quality .................................................................................................................... 6

4.3.

Regulatory .............................................................................................................. 6

4.4.

Report on HMPC Drafting Groups activities ............................................................. 6

4.4.1.

Quality DG ................................................................................................................ 6

4.4.2.

ORGAM DG ............................................................................................................... 7

5.

Organisational, regulatory and methodological matters

5.1.

Mandate and organisation of the HMPC .................................................................. 7

5.1.1.

Strategic Review and Learning Meetings ....................................................................... 7

5.1.2.

Election of Co-opted member ...................................................................................... 7

5.2.

Coordination with EMA Scientific Committees or CMDh-v ....................................... 7

5.2.1.

Scientific Coordination Board Meeting........................................................................... 7

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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4

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5.3.

Coordination with EMA Working Parties/Working Groups/Drafting Groups ........... 7

5.3.1.

Ethanol used as an excipient in medicinal products for human use ................................... 7

5.4.

Cooperation within the EU regulatory network ....................................................... 8

5.4.1.

Coordination with the European Commission ................................................................. 8

5.4.2.

Coordination with European Pharmacopoeia .................................................................. 8

5.4.3.

Coordination with EFSA .............................................................................................. 8

5.5.

Cooperation with International Regulators............................................................. 8

5.6.

Contacts of the HMPC with external parties and interaction with the Interested Parties to the Committee ........................................................................................ 8

5.6.1.

Requests by Interested Parties .................................................................................... 8

5.6.2.

Question on HMPC assessment and national monograph use ........................................... 9

5.7.

Work plan ............................................................................................................... 9

5.7.1.

HMPC work plan 2017 ................................................................................................ 9

5.7.2.

HMPC work plan 2018 ................................................................................................ 9

5.8.

Planning and reporting ........................................................................................... 9

5.9.

Legislation and regulatory affairs ........................................................................... 9

5.9.1.

Evidence on the period of traditional use ...................................................................... 9

5.9.2.

Letter to the HMPC regarding data protection and substance prioritisation ........................ 9

6.

Any other business

6.1.1.

Questions from NCAs on Public statement on pyrrolizidine alkaloid contaminations .......... 10

6.1.2.

Follow up on HMPC 2017 assessors training ................................................................ 10

6.1.3.

Saccharomyces cerevisiae CBS 5926 .......................................................................... 10

6.1.4.

User manual on CxMP/EMA external representation ..................................................... 10

6.1.5.

Submission and use of confidential data for HMPC assessment work .............................. 10

6.1.6.

Preparedness for UK’s withdrawal from the EU – postponed .......................................... 10

6.2.

Documents for information ................................................................................... 10

6.2.1.

HMPC ..................................................................................................................... 10

6.2.2.

MLWP ..................................................................................................................... 11

6.2.3.

ARSP...................................................................................................................... 11

6.2.4.

Feedback on national experiences with HMPC monographs and guidelines ...................... 11

6.2.5.

New PhV information on herbal substances relevant for HMPC assessment...................... 11

6.2.6.

Other ..................................................................................................................... 11

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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1.

Introduction

1.1.

Welcome and declarations of interest of members, alternates and experts Pre-meeting list of participants and restrictions in relation to declarations of interests applicable to the items of the agenda for the HMPC plenary session to be held on 29-30 January 2018. See January 2018 HMPC minutes (to be published post March 2018 HMPC meeting). End of memberships: Gioacchino Calapai (Italy); his membership terminated on 28 November 2017 Per Claeson (Sweden); his membership terminated on 15 January 2018 New memberships: Erika Svedlund, member (Sweden); her membership started on 20 January 2018 Katarzyna Tomaszewska, alternate (Poland); her membership started on 14 December 2017

1.2.

Adoption of agenda HMPC agenda for 29-30 January 2018 Time schedule for 29-30 January 2018

1.3.

Adoption of the minutes HMPC minutes for 20-21 November 2017

2.

European Union herbal monographs and list entries

2.1.

Report on MLWP activities

2.1.1.

MLWP Mandate and Rules of Procedure - revision Action: for adoption Document: Revised mandate/ RoP Rev. 4

2.1.2.

MLWP work plan 2018 Report: MLWP Chair Work plan 2018 Action: for adoption Documents: MLWP work plan 2018, list of monographs due for review

2.1.3.

New substances proposed for HMPC assessment Report: MLWP Chair, E. v. Galen; Action: for discussion

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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Document: inventory, presentation, proposals for HMPC assessment received: Aloysiae folium (Lippia citriodora), Combination: Rehmannia 6, Combination: Species pectorals, Ecliptae prostatae herba, Herniariea herba (in combination), Menyanthes trifoliatae folium (in combination), Pueraria lobatae radix, Salvia miltiorrhizae rhizoma, Siegesbeckia orientalis herba, Tribuli terrestris herba, proposal NL regarding public statements

2.1.4.

Appointment of Rapporteurs and Peer-reviewers Changes of Rapporteurs for Monograph revision

2.1.5.

Appointment of new Rapporteurs for new substances adopted for start HMPC assessment Election of MLWP Chair Report: HMPC Chair; Action: for adoption Document: Call for candidates from 11 January 2018

2.1.6.

Appointment of new MLWP member Report: HMPC Chair; Action: for adoption Document: Call for nominations from 04 January 2018

2.1.7.

Report from the MLWP November 2017 meeting Report: MLWP Chair; Action: for information Document: Draft minutes for the MLWP meeting on 20-23 November 2017

2.2.

Revised EU herbal monographs and list entries for final adoption

2.2.1.

Monograph on Uvae ursi folium Action: for adoption Documents: MO, AR, LoR, OoC; References: 111/111

2.3.

Revised EU herbal monographs and list entries for public consultation

2.3.1.

Monograph on Rusci aculeati rhizoma and supporting documents Action: for adoption Documents: Draft MO, AR, LoR; References: 10/57

2.3.2.

Monograph on Hyperici herba and supporting documents Action: for adoption Documents: Draft MO, AR, LoR; References: 236/236

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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2.4.

EU herbal monographs, list entries and public statements for final adoption None

2.5.

EU herbal monographs, list entries and public statements for adoption for release for public consultation

2.5.1.

Monograph on Cisti cretici folium and supporting documents – postponed to March 2018

3.

Referral procedures None

4.

Guidelines and guidance documents

4.1.

Non-clinical/clinical safety and efficacy and multidisciplinary None

4.2.

Quality None

4.3.

Regulatory None

4.4.

Report on HMPC Drafting Groups activities

4.4.1.

Quality DG Report: QDG Chair •

Meeting report from Q DG virtual meeting held on 07 Dec 2017 Action: for adoption Document: Meeting report



Meeting report from Q DG face to face meeting held on 14-15 Dec 2017 Action: for adoption Document: Meeting report



Draft agenda for the Q DG face-to-face meeting to be held 22 Feb 2018 Action: for information Document: Draft agenda



Work Plan 2018 Action: for adoption Documents: Draft work plan; QDG 2018 meeting dates

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4.4.2.

ORGAM DG Report: ORGAM DG Chair •

Meeting report from ORGAM virtual meeting held on 05 Dec 2017 Action: for adoption Document: Meeting report from ORGAM DG meeting held on 05 Dec 2017



Draft agenda for the ORGAM DG meeting to be held on 20 Feb 2018 Action: for information Document: Draft agenda



Work Plan 2018 Action: for adoption Documents: Draft work plan; ORGAM DG 2018 meeting dates

5.

Organisational, regulatory and methodological matters

5.1.

Mandate and organisation of the HMPC

5.1.1.

Strategic Review and Learning Meetings Report: HMPC Chair, HMPC Vice-chair; Estonia Presidency meeting – Bucharest, 11-12 Oct 2017 – follow up Action: for discussion Documents: presentations; Follow-up discussion paper

5.1.2.

Election of Co-opted member Report: HMPC Chair Action: for adoption Documents: Expertise of HMPC members; Call for nominations from 04 Jan 2018;

5.2.

Coordination with EMA Scientific Committees or CMDh-v

5.2.1.

Scientific Coordination Board Meeting Report: HMPC Chair; Action: for information Documents: Agenda 11 Dec 2017

5.3.

Coordination with EMA Working Parties/Working Groups/Drafting Groups

5.3.1.

Ethanol used as an excipient in medicinal products for human use Action: for discussion Documents: Ethanol PIL comparison, Q&A, email dated 11 January 2018

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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5.4.

Cooperation within the EU regulatory network

5.4.1.

Coordination with the European Commission •

Update on List entries Action: for information



Update on workshop “Complementary and alternative therapies for patients today and tomorrow” held at EP, Brussels, 16 October 2017 Action: for information Document: summary report, REFIT Platform Opinion on the submission by businesses on the THMP Directive

5.4.2.

Coordination with European Pharmacopoeia •

EDQM 13A expert group meeting to be held on 6-7 March 2018 Action: for information



EDQM 13B expert group meeting held on 23-24 January 2018 Action: for information Document: Draft agenda



EDQM TCM expert group meeting to be held on 24-25 January 2018 Action: for information Document: Draft agenda



5.4.3.

EDQM PA working party

Coordination with EFSA •

Safety assessment of hydroxyanthracene derivatives - update Action: for discussion Document: email communication, comments, EFSA draft opinion



Safety assessment of green tea - update Action: for discussion Document: email communication, EFSA draft opinion, draft comments

5.5.

Cooperation with International Regulators None

5.6.

Contacts of the HMPC with external parties and interaction with the Interested Parties to the Committee

5.6.1.

Requests by Interested Parties •

Requests for hearing by EUROCAM Report: HMPC Chair; Action: for discussion Documents: email communication

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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Request for IP status by ECHAMP Report: HMPC Chair; Action: for discussion Documents: Request dated 18 Jan 2018

5.6.2.

Question on HMPC assessment and national monograph use Report: HMPC Chair Action: for discussion Document: Request dated 21 December 2017, Draft HMPC response

5.7.

Work plan

5.7.1.

HMPC work plan 2017 •

Report: HMPC Chair Action: for discussion Document: Work plan 2017 – implementation status



Project 2.1.1. Patients involvement in assessment work Action: for discussion Documents: Presentation



Project 2.1.2. Coordination on safety assessments of herbal constituents – postponed



Project 2.1.3. Cooperation with Academia - postponed Report: MLWP Chair;

5.7.2.

HMPC work plan 2018 •

Report: HMPC Chair Action: for adoption Documents: Draft Work plan 2018

5.8.

Planning and reporting None

5.9.

Legislation and regulatory affairs

5.9.1.

Evidence on the period of traditional use Action: for discussion

5.9.2.

Documents: Request to EC, draft response Jan 2017; presentationsLetter to the HMPC regarding data protection and substance prioritisation Report: HMPC Chair Action: for information Document: Letter dated 28 Sept 2017, EMA response dated 22 Jan 2018

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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6.

Any other business

6.1.1.

Questions from NCAs on Public statement on pyrrolizidine alkaloid contaminations Action: for discussion Documents: Response to questions from BE & NL received in May 2017; Literature

6.1.2.

Follow up on HMPC 2017 assessors training Report: QDG Chair Action: for discussion Documents: agenda, presentations

6.1.3.

Saccharomyces cerevisiae CBS 5926 Action: for discussion Documents: draft letter dated 22 Jan 2018 rev HMPC Chair; table status in MS

6.1.4.

User manual on CxMP/EMA external representation Action: for discussion Documents: Presentation; User manual

6.1.5.

Submission and use of confidential data for HMPC assessment work Action: for discussion Documents: information received during public consultations

6.1.6.

Preparedness for UK’s withdrawal from the EU – postponed

6.2.

Documents for information

6.2.1.

HMPC Table of Decisions from HMPC meeting held on 20-21 November 2017 Overview of expertise of members HMPC and subgroups Meeting report from HMPC meeting held on 20-21 November 2017 Overview of status of HMPC assessment work – priority list Inventory of herbal substances for assessment work Abbreviations in HMPC agendas/minutes Common names of herbal substances in all languages

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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6.2.2.

MLWP •

Overview of status of HMPC/MLWP assessment work



Draft agenda of MLWP meeting to be held on 30 January-1 February 2018

6.2.3.

ARSP •

English template



English summaries for publication:

6.2.4.



Hederae helicis folium



Meliloti herba



Ribis nigri folium

Feedback on national experiences with HMPC monographs and guidelines

6.2.5.



draft template



summary feedback, examples feedback received

New PhV information on herbal substances relevant for HMPC assessment summary of available PSURs



6.2.6.

Other •

PCWP/HCPWP meetings:



Meeting summary of the PCWP meeting with all eligible organisations held on 22 November 2017 (EMA/757232/2017): for information



Anticipated PMDA/MHLW Recommendations for Regulatory Action



EU herbal monographs, list entries and public statements post adoption: for information 

Publication delays 2016/2017 updates



Remaining publication delays: o

Allii sativi bulbus

o

Pistacia lentiscus (mastix)

Committee on Herbal Medicinal Products (HMPC) EMA/HMPC/18658/2018

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