EMA press release for September meeting of the CVMP
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.
