The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 April 2016 (Link). General news relating to regulatory affairs includes:
- Positive opinion adopted for Elanco’s Clynav, the first DNA vaccine for Salmon (Link).
- The Article 35 referral for colistin combination products to be administered orally to food-producing species has concluded with a negative opinion, the CVMP recommending that all products concerned should be withdrawn from the market.
Quality guidance:
- The Committee adopted a draft reflection paper for consultation on the dissolution specification for generic oral immediate release products.
Efficacy guidance:
- The Committee adopted a revised reflection paper, for a second consultation, on anthelmintic resistance.
- Following the finalisation of VICH GL52, the Committee adopted a concept paper for consultation on the revision of the guideline on the conduct of bioequivalence studies for VMPs.
Immunologicals guidance:
- The Committee adopted a new concept paper for consultation on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use.
Replacement, Reduction, Refinement of animal testing (3Rs) guidance:
- The Committee adopted a reflection paper for consultation providing an overview of the current regulatory testing requirements for VMPs and opportunities for implementation of the 3Rs.
The adopted documents will published on the EMA website in the coming weeks.
