Seasonal vaccine approval - EUROPEAN UNION - Jim Robertson National Institute for Biological Standards and Control National Institute for Biological Standards and Control Assuring the quality of biological medicines
Routes for approval National Mutual Recognition procedure must have already received a marketing authorisation in one Member State; compulsory for all medicinal products to be marketed in a Member State other than that in which they were first authorised Centralised (via EMA)
Regulations and guidance European Commission Directive 2001/83 EC + amendments (mutual recognition) Regulation (EC) no 726/2004 (centralised procedure) EMA website Pre-authorisation regulatory and procedural guidance Vaccine (general) specific guidance Influenza vaccine guidance
EU Seasonal vaccines (not comprehensive) National Abbott Influvac Imuvac Baxter Preflucel Crucell Inflexal V CSL Enzira GSK Fluarix Fluarix tetra (pend.) Novartis Agrippal Fluad Omnivest Fluvalab PM-MSD Flu vaccine Centralised Medimmune Fluenz(LAIV) Novartis Optaflu(cell) SP IDflu/intanza
Annual updates National/Mutual recognition European Commission NOTICE TO APPLICANTS A GUIDELINE ON FAST TRACK PROCEDURES FOR HUMAN INFLUENZA VACCINES MAY 1999 Being revised to take into account Variations Regulations
Annual updates Centralised Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure 8 November 2010 EMA/CHMP/BWP/99698/2007 Rev. 1 Committee for Medicinal Products for Human Use (CHMP) Annex I. variation application(s) content for live attenuated influenza vaccines 21 July 2011 EMA/CHMP/BWP/577998/2010 Committee for Medicinal Products for Human Use (CHMP) Being revised to take into account Variations Regulations
Variation regulations COMMISSION REGULATION (EU) No 712/2012 of 3 August 2012 amending Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products Article 12 Article 13F Article 18 refers to mutual recognition/decentralised procedures refers to national procedures refers to centralised procedures Commission guideline on the details of the various categories of variations (2010/C 17/01)
Variations Regulations The Regulations define a Type-II variation as a major variation that may have a significant impact on the quality, safety or efficacy of a medicinal product. The Regulations and the Classification guideline set out a list of changes to be considered as Type-II variations.
New influenza guidelines 22 September 2011 EMA/CHMP/VWP/734330/2011 Committee for Medicinal Products for Human Use (CHMP) Concept paper on the revision of guidelines for influenza vaccines New guidance will replace: Pandemic guidelines Harmonisation guideline Cell culture guideline LAIV guideline, etc.
Quality issues Guideline on Influenza Vaccines Quality Module DRAFT EMA/CHMP/BWP/310834/2012 (March 2013) Vaccine Working Party and Biologics Working Party (VWP, BWP) Scope: vaccines for which experience exists - Inactivated, seasonal, pre-pandemic, pandemic Live attenuated, seasonal Annual updates
Non-clinical and Clinical Under development
Seasonal updates Note for Guidance on Harmonisation of Requirements for Influenza Vaccines (CPMP/BWP/214/96) Yearly choice of strain Labelling Potency Batch release Clinical trials Small numbers of subjects (2 x 50) Assess immunogenicity and tolerance
Novel vaccines Guidance available Recombinant DNA products Adjuvants Pre-clinical assessment Clinical assessment DNA vaccines Viral vectored vaccines
Links for guidelines and Commission documents highlighted List of EMA scientific guidelines for vaccines: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_co ntent_000407.jsp&mid=wc0b01ac058002958b Regulation (EC) No. 726/2004 for the authorisation and supervision of medicinal products: http://eurlex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2004:136:0001:0033:en:pdf Variations Regulation (EC) No. 712/2012: http://eurlex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2012:209:0004:0014:en:pdf amending Variations Regulation (EC) No. 1234/2008: http://eurlex.europa.eu/lexuriserv/lexuriserv.do?uri=oj:l:2008:334:0007:0024:en:pdf Commission guidance on categories of Variations: http://ec.europa.eu/health/files/eudralex/vol-2/c17_1/c17_1_en.pdf European Commission guideline on fast track procedures for human influenza vaccines: http://ec.europa.eu/health/files/eudralex/vol- 2/c/fast_trackfinal_may99_en.pdf Commission Directive 2001/83 EC on medicinal products for human use: http://ec.europa.eu/health/files/eudralex/vol- 1/dir_2001_83_cons/dir2001_83_cons_20081230_en.pdf