Send a question via our website www.ema.europa.eu/contact. © European Medicines Agency ... for start of revision if maj
22 November 2016 EMA/HMPC/114746/2017 Inspections, Human Medicines Pharmacovigilance & Committees Division
Work plan for the HMPC Quality Drafting Group (Q DG) 2017
Chair
Status
L. Anderson
Final
1. Meetings scheduled for 2017 Meeting dates: 23-24 February (face-to-face), 20 April, 28 June, 7 September, 19 October and 7 December. One face-to-face meeting will be organised in February 2017, other meetings will be held virtually.
2. New guidance documents •
Guidance on the use of new analytical methods for the quality control of herbal medicinal products. Action: Publication of reflection paper for public consultation and proposal for follow-up such as Q&A.
•
Guidance on the control of pyrrolizidine alkaloids in herbal medicinal products. Action: Check existing guidance documents (including GACP and specification guideline) for necessary updates and initiate subsequent revisions and/or draft transitionally Q&A.
3. Update, extension or revision of existing guidance documents •
Revision of the Guideline on quality on herbal medicinal products. Action: Publication of the draft revised GL for consultation after coordination with QWP/CHMP and CVMP).
•
Revision of the Guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and HMP/THMPs.
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, 2017. Reproduction is authorised provided the source is acknowledged.
Action: Publication of the draft revised GL for consultation after coordination with QWP/CHMP and CVMP). •
Update/revision of questions & answers on quality of herbal medicinal products (EMA/HMPC/41500/2010). Action: (1) review and add new Q&A following quality assessors training 2015 (skip testing, stability, GACP/GMP, assay and markers; microbiological issues), and reflection paper on microbiological aspects; (2) check for redundant Q&A taken into revised guidelines (quality, specifications) and reduce accordingly.
•
Review and update of the Guideline on declaration of herbal substances / preparations in (T)HMP. Action: Review for necessary updates and publication of correction if minor or publish concept paper for start of revision if major.
•
Review of the Reflection paper on markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products. Action: Review for suitability vis-a-vis Ph. Eur. definitions and HMPC monographs/ assessment reports with focus on definitions for active markers and markers with known therapeutic activity (in coordination with MLWP).
4. Coordination with EDQM •
Development and review of pharmacopoeial monographs and general chapters and notices (including PAs, essential oils, assay methods). Action: On-going activity, selection and discussion of relevant topics for the HMPC via participation of an EDQM representative in Q DG meetings and Q DG Observers at Ph. Eur. expert groups 13A, 13B and TCM. Q DG observers: M. Brum or I. Chinou/HMPC (13A), B. Kroes (13B), R. Länger (TCM); EDQM observer at Q DG: M. Bald
•
Involvement in and contribution to Certification of herbal active substances in view of MA and registration procedures for (traditional) herbal medicinal products. Action: (1) Compile a list of issues in relation to the use of CEP in applications for (T)HMPs (2) Propose amendments / clarifications on the use of CEP in the existing quality guidance documents where appropriate (3) Prepare as appropriate HMPC comments on the established CEP procedure for herbal active substances with emphasis on (the suitability of) the information that is made available on a CEP. Support the development of new and the revision of existing CEP Guidance documents.
5. General •
Provide input to general quality guidelines and other guidance documents applicable to herbal substances/preparations/medicinal products. Action: On-going activity, monitor QWP activities and draft/ propose to HMPC input as necessary.
•
Provide input on quality questions for herbal medicinal products in the framework of HMPC coordination with other EMA committees/working parties (e.g. SA procedures with SAWP) if required.
Work plan for the HMPC Quality Drafting Group (Q DG) 2017 EMA/HMPC/114746/2017
Page 2/3
•
HMPC Assessors training on quality of herbal medicinal products. Action: Propose specific topic to HMPC for assessors training 2nd half 2017 and in liason with EMA secretariat identify speakers and support organisation.
Work plan for the HMPC Quality Drafting Group (Q DG) 2017 EMA/HMPC/114746/2017
Page 3/3
