EMA press release for September meeting of the CVMP

11 September, 2015

The EMA has posted the press release with details of the CVMP's meeting of 8 - 10 September 2015 (Link). General news relating to regulatory affairs includes:

  • Quality guidance: an updated Q & A on complex manufacturing processes was adopted (yet to be published)
  • ERA guidance: a guideline on the assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in VMPs was adopted (Link)
  • Immunologicals guidance:
    • ​A draft concept paper on requirements for the production and control of allergen products for use in animals was adopted for public consultation (Link)
    • A revised guideline on the procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus (BVDV) was adopted (Link)
    • A reflection paper on the use of heat treatment to inactivate endogenous retroviruses in live immunological VMPs was adopted (Link)
    • A reflection paper on the replacement of cell lines used for the production of immunological VMPs was adopted (Link)
  • Bioequivalence guidance: VICH GL52 (Bioequivalence: blood level bioequivalence study) was adopted (Link). As a consequence, the corresponding CVMP guideline will be revised accordingly.
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