seasonal vaccine approval -european union - … vaccine approval-european union - jim robertson...
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National Institute for Biological Standards and Control
Assuring the quality of biological medicines
Seasonal vaccine approval
- EUROPEAN UNION -
Jim Robertson
National Institute for Biological
Standards and Control
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 refers to mutual recognition/decentralised proceduresArticle 13F refers to national proceduresArticle 18 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.
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.
New influenza guidelines
Guideline on Influenza Vaccines –
Quality ModuleDRAFT
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
Quality issues
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://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:EN:PDF
• Variations Regulation (EC) No. 712/2012: http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:209:0004:0014:EN:PDF
• amending Variations Regulation (EC) No. 1234/2008: http://eur-
lex.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