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).

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© 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

4

4

7

Page 2/11

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

10

Page 3/11

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

Page 4/11

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

Page 5/11

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

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

Page 6/11

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

Page 7/11

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

Page 8/11



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

Page 9/11

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

Page 10/11

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

Page 11/11

HMPC agenda of the 29-30 January 2018 meeting - European ...

Jan 25, 2018 - Quality DG . ... Cooperation within the EU regulatory network ....................................................... 8 ... Cooperation with International Regulators .

152KB Sizes 1 Downloads 317 Views

Recommend Documents

HMPC Agenda 29-30 January 2018 - European Medicines Agency
Jan 25, 2018 - 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 on- going procedures for which a final decisio

CAT agenda of the 17-19 January 2018 meeting - European ...
Jan 17, 2018 - Autologous CD34+ cells derived from bone marrow ..... well as information on appointment of Rapporteurs for new ATMP applications.

HMPC agenda of the 21-22 November 2016 meeting - European ...
Nov 18, 2016 - Joint CVMP/CHMP ad hoc expert group meeting on 3Rs (JEG 3Rs ..... Documents: Email from HMPC Chair, 26 May 2016; Summary in ...

PDCO agenda of the 23-26 January 2018 meeting - European ...
Jan 23, 2018 - Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be

Minutes of the HMPC 30-31 January 2017 meeting - European ...
Send a question via our website www.ema.europa.eu/contact ... 5. 1.1. Welcome and declarations of interest of members, alternates and experts ............ 5. 1.2. ...... Report of the PCPWP/HCPWP workshop on social media – 19 Sep 2016.

HMPC agenda of the 21-22 November 2016 meeting - European ...
Nov 18, 2016 - Revised EU herbal monographs and list entries for final adoption .......................... 6. 2.2.1. ..... Any other business. 12. 6.1. .... Documents: Email from HMPC Chair, 26 May 2016; Summary in presentation; Summary of. Strategic

Agenda of January 2018 CVMP meeting - European Medicines Agency
Jan 16, 2018 - framework of Regulation (EC) No 1049/2001 on access to documents because they are subject to on- going procedures for ... Co-rapp: C. Muñoz. For decision: Need for oral explanation. For adoption: Scientific overview and list of outsta

HMPC agenda of the 20-21 November 2017 meeting - European ...
Nov 20, 2017 - Committee on Herbal Medicinal Products (HMPC). EMA/HMPC/757234/2017. Page 7/11. 4.4.3. Template update – Template on HMPC opinion ...

HMPC agenda of the 19-20 September 2016 meeting - European ...
Sep 19, 2016 - Procedure Management and Committees Support Division ..... plan 2016 – current status; HMPC work plan tracking tool 2016 ... Update of documents on EU Good Pharmacovigilance Practices (EU-GVP) ... (HCPWP) joint meeting – Workshop o

HMPC agenda of the 19-20 September 2016 meeting - European ...
Sep 19, 2016 - Revised EU herbal monographs and list entries for final adoption . ..... (HCPWP) joint meeting – Workshop on social media – 19 September ...

Minutes of the HMPC 30-31 January 2017 meeting - European ...
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 on- going procedures for which a final decision has not yet b

Agenda - HMPC agenda of the 30-31 May 2016 meeting - European ...
May 27, 2016 - Joint CVMP/CHMP ad hoc expert group meeting on 3Rs (JEG 3Rs ..... Documents: Presentations; Email from HMPC Chair, 26 May 2016; ...

Agenda - HMPC agenda of the 30-31 May 2016 meeting - European ...
May 27, 2016 - Coordination with CMDh – Addendum to the QRD templates for SmPC, Labelling and Patient. Leaflet on .... Any other business. 10. 6.1. .... Documents: Presentations; Email from HMPC Chair, 26 May 2016; Summary in.

HMPC Agenda 04-05 June 2018 - European Medicines Agency
Jun 5, 2018 - Some of the information contained in this agenda is considered ... access to documents within the framework of Regulation (EC) No 1049/2001 ...

PDCO agenda of the 20-23 March 2018 meeting - European ...
Mar 20, 2018 - 20 March 2018, 17:30- 19:00, room 3A. 21 March 2018, 08:30- 19:00, room 3A. 22 March 2018, 08:30- 19:00, room 3A. 23 March 2018, 08:30- 13:00, room 3A. Health and safety information ...... GlaxoSmithKline Trading Services Limited; Prim

Agenda - PDCO agenda of the 24-27 January 2017 meeting
Jan 27, 2017 - Opinions on Compliance Check . ...... vector encoding for the human ADA gene - Orphan - EMEA-001974-PIP01-16. Pr Bobby Gaspar; Severe ...

Agenda - PDCO agenda of the 24-27 January 2017 meeting
Jan 27, 2017 - Minutes of the PCWP/HCPWP joint meeting – 20 September 2016 (EMA/625038/2016) .... 37. 9.3.4. .... T-lymphocytes enriched leukocyte preparation depleted ex vivo of host host- .... BioCryst UK Ltd; Treatment of influenza.

Agenda - CAT agenda of the 18-20 January 2017 meeting - European ...
Jan 18, 2017 - Withdrawal of initial marketing authorisation application . ..... and 3Rs Best Practice document that were subject to public .... within the EU regulatory network and international regulators as well as direct interaction with.

HMPC agenda of the 11-12 July 2016 meeting - European Medicines ...
Jul 8, 2016 - Send a question via our website www.ema.europa.eu/contact. © European Medicines ..... Contacts of the HMPC with external parties and interaction with the Interested. Parties to the ... Any other business. 10. 6.1. Topics for ...

Minutes of the HMPC 21-22 November 2016 meeting - European ...
Jan 31, 2017 - Three tea combinations (gastrointestinal disorders, mental stress, to aid sleep) ..... HMPC Q DG to further integrate requirements on PA testing into ... Documents: Work plan 2016 – current status; HMPC work plan tracking tool 2016 .

HMPC agenda of the 11-12 July 2016 meeting - European Medicines ...
Jul 8, 2016 - Patient Leaflet template concerning advice on preparations of herbal teas ..... Documents: Email from HMPC Chair, 26 May 2016; Summary in ...

Minutes of the HMPC 21-22 November 2016 meeting - European ...
Jan 31, 2017 - Documents: Presentation; Draft procedure; Template example ... Documents: Procedure for the election of HMPC Chair; Email, 29 Sep 2016; ...

HMPC agenda of the 17-18 July 2017 meeting - European Medicines ...
Jul 14, 2017 - Any other business. 6.1. Topics for discussion. 6.1.1. Question concerning the adjustment of product to HMPC monographs. Action: for discussion. Documents: Email correspondence 11 May 2017; Draft response. 6.1.2. Follow up on Public St

PRAC draft agenda of meeting 11–14 June 2018 - European ...
3 days ago - Of note, this agenda is a working document primarily designed for PRAC members and the work the. Committee .... New signals detected from EU spontaneous reporting systems . .... Risk management plans (RMPs). 17. 5.1.