During 2014, several European guidance documents on biological drug substances or drug products were developed or revised. Some of these documents became effective end of 2014, for some other drafts or revisions, the deadline for comments ended. Follwing a short overview:
Note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/214/96)
Cell culture inactivated influenza vaccines - Annex to note for guidance on harmonisation of requirements for influenza vaccines (CPMP/BWP/214/96)
Points to consider on the Development of Live Attenuated Influenza Vaccines (EMEA/CPMP/BWP/2289/01)
Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure (EMA/CHMP/BWP/99698/2007 Rev. 1)
Annex I variation application(s) content for live attenuated influenza vaccines (EMA/CHMP/BWP/577998/2010)
Guideline on Dossier Structure and Content for Pandemic Influenza Vaccine Marketing Authorisation Application (EMEA/CPMP/VEG/4717/03 rev. 1)