Guidelines effective since end of 2014

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:

Guidelines which became effective in 2014:

1. First revision of  Similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues

2. Influenza vaccines - Quality module  - This Module replaces the Quality requirements of the following guidelines:

  • 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)

3. Use of porcine trypsin used in the manufacture of human biological medicinal products

4. Guideline on the declaration of the quantitative composition / labelling of biological medicinal products that contain modified proteins as active substance

Drafts and Revisions with deadline for comments:

1. Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission

2. Viral safety of plasma-derived medicinal products with respect to hepatitis E virus

3. Revision of guideline on epidemiological data on blood transmissible infections

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