Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2018

Transcription

1 4 December 2017 EMA/CHMP/CVMP/QWP/504882/2017 Committee for Medicinal Products for Human Use (CHMP) Committee for Medicinal Products for Veterinary Use (CVMP) Work plan for the joint CHMP/ CVMP Quality Working Party (QWP) for 2018 Chairperson: Keith Pugh Status of the work plan December 2017: Final The following work plan is a joint human and veterinary plan. H - indicates a human only topic; V - indicates a veterinary only topic; H/V - indicates a joint human/veterinary topic. The activities outlined in the work plan for 2018 have been agreed considering the respective business priorities, as well as the Agency s relocation as a result of the UK s exit from the EU and its impact on the Agency s business continuity, and may be subject to further review and reprioritisation in accordance with the business continuity plan of the Agency. 1. Meetings scheduled for 2018 Face-to-face meetings are planned for the following dates: 27 February 1 March June 2018 (including QWP/ Interested Parties meeting) November 2018 Additional virtual meetings may be organised ad-hoc to respond to time-sensitive requests on products and to progress guidelines, as required. All QWP plenary meetings have participants with expertise in the quality of human and veterinary medicinal products, observers from the EDQM (European Directorate for Quality of Medicines and HealthCare), EU accession countries and occasionally from regulatory authorities outside the EU. Each 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

2 meeting is scheduled to take 2.5 days involving about 60 experts per meeting. Break-out sessions on specific subjects, involving a subset of the participants are organised during the meetings. H/V interested parties meetings (1/year); Drafting/expert groups involving, if appropriate, external experts and representatives of other working parties and/or inspectors (virtual meetings - as deemed necessary); QWP core team (11 virtual meetings/year) - specific procedures support; and H/V joint QWP/BWP/GMDP IWG EMA Process Analytical Technology team (1 x 1 day meetings + 2 virtual meetings). Additional virtual meetings may be organised ad-hoc to respond to time-sensitive requests on products, as required. 2. Guidelines and Reflection Papers 2.1. New EU Guidelines and Reflection Papers Action: Lead Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container, EMA/CHMP/CVMP/QWP/BWP/850374/2015 (H/V) Target date Final guideline to be published Q Public consultation of the draft guideline ended 13 October Contribution of BWP. Guideline on quality and equivalence of topical products (H) Target date Draft guideline to be released for 6 month public consultation Q Public consultation of the concept paper ended 22 July Contribution of PKWP. Guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product (H) Target date Draft guideline to be released for public consultation Q Public consultation of the concept paper ended 16 May Contribution of BWP. Reflection paper on quality aspects of medicines for older people (H) Target date Final reflection paper to be published Q Public consultation of the reflection paper will end 31 January Contribution of BWP. Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 EMA/CHMP/CVMP/QWP/504882/2017 Page 2/7

3 Reflection paper on risk assessment requirements to control elemental impurities in veterinary medicinal products (V) Target date Final reflection paper to be published Q Reflection paper for public consultation Q Action: Specialised input Guideline on DNA reactive impurities in veterinary medicinal products, EMA/CVMP/SWP/553001/2016 (V) CVMP SWP Target date Draft guideline to be released for public consultation Q Contribution on quality aspects. Multidisciplinary project led by SWP-V and involving QWP and EWP-V. Guideline on equivalence studies for the demonstration of therapeutic equivalence for products that are locally applied locally acting in the gastrointestinal tract as addendum to the guideline on the clinical requirements for locally applied, locally acting products containing known constituents (H) PKWP Target date Final guideline to be published Q Contribution on quality aspects. Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development (H) Target date BSWP on the reflection paper received during the public consultation will be discussed in Contribution on quality aspects. Reflection paper providing an overview of the current regulatory testing requirements for Human medicinal products and opportunities for implementation of the 3Rs, EMA/CHMP/CVMP/JEG-3Rs/742466/2015 (H) JEG 3Rs Target date Reflection paper to be finalised following consultation Q Contribution to comments arising from the public consultation on quality aspects. Reflection paper providing an overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs, EMA/CHMP/CVMP/JEG-3Rs/164002/2016 (V) Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 EMA/CHMP/CVMP/QWP/504882/2017 Page 3/7

4 JEG 3Rs Target date Reflection paper to be finalised following public consultation Q Contribution to comments arising from the public consultation on quality aspects EU Guidelines under revision Action: Lead Guideline on the manufacture of the finished dosage form, EMEA/CVMP/126/95 (V) Target date Draft guideline to be released for 6 month public consultation Q Public consultation of the concept paper ended 17 October Guideline on quality of water for pharmaceutical use, CPMP/QWP/158/01 (H+V) Target date Draft guideline to be released for 6 month public consultation Q Public consultation of the concept paper ended 6 June Contribution of GMP/GDP IWG, CAT, BWP, IWP. Guideline on the pharmaceutical quality of inhalation and nasal products, EMEA/CHMP/QWP/49313/2005 (H) Target date Draft guideline to be released for 6 month public consultation Q Public consultation of the concept paper ended 30 June Contribution of Respiratory DG. Action: Specialised input Guideline on the conduct of bioequivalence studies for veterinary medicinal products, EMEA/CVMP/016/00-Rev.3 (V) CVMP - EWP Target date Draft revised guideline to be finalised following public consultation Q Contribution on quality aspects to revision of existing guideline. Multidisciplinary topic led by EWP-V and involving QWP. Revision proposed as consequence of finalisation of corresponding VICH GL52. Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of Asthma and Chronic Obstructive Pulmonary Disease (COPD) in adults and for use in the treatment of asthma in children and adolescents, EMEA/CPMP/EWP/4151/00 Rev.1 (H) Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 EMA/CHMP/CVMP/QWP/504882/2017 Page 4/7

5 CHMP Respiratory Drafting Group Target date Draft guideline to be released for 6 month public consultation in Contribution on quality aspects. Annex to the European Commission Guideline (EMA/CHMP/302620/2017) Excipients in the Label and Package leaflet for Medicinal Products for Human Use (SANTE ) (H) CHMP ExcpDG Target date Revised Annex to be published Q Contribution on quality aspects. Multidisciplinary group. Revised Annex (containing updated ethanol) and public consultation of PL information for other individual excipients. GMP Guide: Annex 1 (Manufacture of Sterile Medicinal Products) Target date To provide the European Commission with a final text for publication Q Contribution on quality aspects, as needed (V)ICH Guidelines ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Target date N/A Step 1 completed. Input to the development of ICH Guideline Q12 jointly with BWP. Discussion on the Common Technical Document (ICH topic M4). VICH GL3 Annex - Stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV Target date Contribute to EU position. Step 2 ongoing. VICH GL18 Impurities: Residual solvents in new veterinary medicinal products, active substances and excipients Target date N/A Step 9 - develop revised guideline, bringing it in line with revisions made in ICH Q3C (R5) and ICH Q3C (R6). Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 EMA/CHMP/CVMP/QWP/504882/2017 Page 5/7

6 3. Medicinal Products-specific activities 3.1. Pre-Authorisation activities Contribution to the scientific advice and protocol assistance provided by the SAWPs (H or V) upon their request Contribution to Innovation Task Force 3.2. Evaluation and Supervision activities Contribution/recommendation to CHMP/CVMP marketing authorisation or post-authorisation evaluation procedures upon request of CHMP/CVMP Input on non-centrally authorised product evaluation/referral procedures upon request of CMDh/ CMDv Contribution to referral discussions upon request from CHMP/CVMP 4. Input in European activities 4.1. Training for the network and knowledge building Organise specific virtual trainings 5. Input in International activities (beyond ICH guidelines) 5.1. Activities with other regulators H/V collaboration with drug regulatory authorities outside the EU/EEA in addition to (V)ICH activities: Liaison with FDA (e.g. through the EMA PAT team), Health Canada and the Japanese Ministry of Health, Labour and Welfare, on matters of common interest Activities with international bodies H/V collaboration with EDQM on: Project for impurities: review of qualification and limits of impurities of existing medicinal products authorised on the market in the EU/EEA with regards to new or revisions of specific monographs; Review of pharmacopoeial monographs and general chapters and notices; Sampling and testing of centrally authorised products; Pharmacopoeial discussion group (PDG), through matters referred to the QWP by EDQM; Involvement in and contribution to CEP procedures; and Involvement in and contribution to quality related seminars organised by EDQM. Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 EMA/CHMP/CVMP/QWP/504882/2017 Page 6/7

7 6. Contribution to dialogue and engagement with stakeholders and external parties Organisation of the annual meeting with pharmaceutical industry representatives on issues of joint interest: June Continue dialogue on new technologies and approaches (e.g. consultation on QWP concept papers and guidelines, through workshops with interested parties on topics of common interest). In addition to the actions identified above, the working party can be involved in any other activities foreseen in its mandate: pdf Work plan for the joint CHMP/ CVMP Quality Working Party for 2018 EMA/CHMP/CVMP/QWP/504882/2017 Page 7/7

8 14 December 2017 EMA/CHMP/SWP/420217/2017 Work plan for the Safety Working Party (SWP) for 2018 Chairperson: Jan Willem van der Laan Status of the work plan: Adopted The activities outlined in the work plan for 2018 have been agreed considering the respective business priorities, as well as the Agency s relocation as a result of the UK s exit from the EU and its impact on the Agency s business continuity, and may be subject to further review and reprioritisation in accordance with the business continuity plan of the Agency. 1. Meetings scheduled for 2018 Face-to-face meetings and virtual meetings (VM) are planned for the following dates: 16 January 2018 (VM) February 2018 (F2F) 13 March 2018 (VM 17 April 2018 (VM) 23 May 2018 (VM) 19 June 2018 (VM) 17 July 2018 (VM) 21 August 2018 (VM) 11 September 2018 (VM) 9-10 October 2018 (F2F) 6 November 2018 (VM) 4 December 2018 (VM) The above mentioned dates may be modified as needed. Additional virtual meetings may be organised ad-hoc to respond to time-sensitive requests on products and to progress guidelines, as required. 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0) Facsimile +44 (0) Send a question via our website An agency of the European Union European Medicines Agency, Reproduction is authorised provided the source is acknowledged.

9 2. Guidelines 2.1. New EU Guidelines Action: Lead Guideline on the non-clinical evaluation of radiopharmaceuticals Target date Draft to be published for consultation Q None Reflection paper on the qualification of non-genotoxic impurities Target date Draft to be published for consultation Q None Reflection paper on non-clinical requirements for plasma-derived replacement therapies Target date Draft to be published for consultation Q None Action: Specialised input Implementation of risk based prevention of cross contamination in production, and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/SWP/169430/2012) Question and answer document GMP Inspectors WG Target date Final Q&A document to be published Q None Reflection paper providing an overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs (EMA/CHMP/CVMP/JEG 3Rs/742466/2015) J3RsWG Target date Final reflection paper to be adopted in Q Published for 6-month consultation in November 2016 Work plan for the Safety Working Party (SWP) for 2018 EMA/CHMP/SWP/420217/2017 Page 2/6

10 Review and update of EMA guidelines to implement best practice with regard to 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products Report on actions taken (EMA/CHMP/CVMP/JEG-3Rs/677407/2015) J3RsWG Target date Final report to be adopted in Q Public consultation until 31 October EU Guidelines under revision Action: Lead Environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00) Target date Draft guideline to be released for public consultation in Q Concept paper published Q Drafting group involving SWP members and specialised ERA assessors Action: Specialised input Annex to the EC Guideline (EMA/CHMP/302620/2017) Excipients in the Labelling and Package leaflet for Medicinal Products for Human Use (SANTE ) CHMP Excipients Drafting Group Target date Revised Annex to be published Q Multidisciplinary group. Revised Annex (containing updated ethanol) and public consultation of PL information for other individual excipients 2.3. ICH Guidelines ICH S1: Rodent Carcinogenicity Studies for Human Pharmaceuticals - Regulatory Notice Document Target date Step 2a/b planned for Q Regulatory review of Carcinogenicity Assessment Documents (CAD) and Carcinogenicity Study Summaries ongoing ICH S5 (R3): Detection of Toxicity to Reproduction for Medicinal Products and male fertility- Revision Target date Step 4 planned for Q Step 3 documents under public consultation until 28 th February 2018 ICH S9 Q&A: Nonclinical Evaluation for Anticancer Pharmaceuticals Questions and Answers Target date Step 4 planned for Q Ongoing drafting work to address public comments received Work plan for the Safety Working Party (SWP) for 2018 EMA/CHMP/SWP/420217/2017 Page 3/6

11 ICH S11: Nonclinical Safety Testing in Support of Development of Paediatric Medicines Target date Step 2b to be released for consultation Q None ICH M7 (R2) Addendum: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Target date Step 2a/b document to be released for consultation Q None ICH Q3C (R6) Impurities: Guideline for Residual Solvents Target date Step 2a/b document to be released for public consultation Q Work ongoing on 2-methyltetrahydrofuran, cyclopentylmethylether and tertbutanol ICH Q3D Impurities: Guideline for Elemental Impurities Target date Step 2a/b document planned by June 2018 Definition of PDEs for dermal route of administration for 26 elemental impurities 3. Medicinal Products-specific activities 3.1. Pre-Authorisation activities Contribution to Scientific Advice and Protocol Assistance activities, discussed at monthly SWP virtual meetings (15/year) Expert contribution to Innovation Task Force (ITF) (5/year) 3.2. Evaluation and supervision activities Requests from CHMP for input on evaluation activities (5/year) Expert contribution to the Non-clinical Working Group of the PDCO (monthly teleconferences with individual SWP members) Contribution to product-related assessment post-authorisation following specific CHMP request (4/year) Other requests from other Scientific committees (e.g. PRAC, CAT, CVMP, HMPC) and working parties (e.g. QWP, BWP, etc.) on product-related issues (6/year) Work plan for the Safety Working Party (SWP) for 2018 EMA/CHMP/SWP/420217/2017 Page 4/6

12 4. Input in European activities 4.1. Training for the network and knowledge building Contribution to annual pre-clinical assessor meeting. Date and location to be defined Contribution to GMP Inspectors training on Implementation of risk based prevention of cross contamination in production, and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/SWP/169430/2012), date to be defined Contribution to EU NTC training activities in non-clinical area upon request Activities to promote network awareness of novel reproductive toxicity evaluation framework (see ICH S5(R3) 4.2. Other input in European activities Contribution and involvement in non-clinical safety projects of the Innovative Medicines Initiative (IMI), such as: TRANSQST, SafeSciMET Contribution to Horizon 2020 research projects: EU-ToxRisk Contribution to other EU Institutions (EC, EU Agencies) and Initiatives as required: EMCDDA risk assessment activities; EPAA (European Partnership for Alternative Approaches to Animal Testing); etc. 5. Input in International activities (beyond ICH guidelines) Quarterly virtual meetings with FDA on non-clinical development of oncology products Health and Environmental Sciences Institute part of International Life Sciences Institute (ILSI- HESI): - Translational Biomarkers of Neurotoxicity (NeuTox) - Framework for intelligent non-animal alternative methods project - Technical Commission on emerging issues - Developmental and Reproductive Toxicology Working Group - CT-TRACS (Cell-therapy TRAcking, Circulation, & Safety) 6. Contribution to dialogue and engagement with stakeholders and external parties Annual SWP Interested parties meeting (12 February 2018) Brainstorming sessions on emerging non-clinical safety topics with EFPIA in the margins of the annual pre-clinical assessors meeting Work plan for the Safety Working Party (SWP) for 2018 EMA/CHMP/SWP/420217/2017 Page 5/6

13 Meeting with interested parties as needed e.g. learned societies, public health stakeholders (public health professionals, patients organisations), and pharmaceutical industry representatives upon request In addition to the actions identified above, the working party can be involved in any other activities foreseen in its mandate: Work plan for the Safety Working Party (SWP) for 2018 EMA/CHMP/SWP/420217/2017 Page 6/6