Guidance documents adopted in CVMP April meeting now published

29 April, 2016

The EMA has now published the following documents adopted in the April meeting of the CVMP:

Efficacy guidance:

  • Revised reflection paper on anthelmintic resistance (Link) and the overview of comments (Link).
  • Concept paper on the revision of the guideline on the conduct of bioequivalence studies for VMPs. (Link)

Immunologicals guidance:

  • Concept paper on DNA vaccines non-amplifiable in eukaryotic cells for veterinary use (Link).

Replacement, Reduction, Refinement of animal testing (3Rs) guidance:

  • Reflection paper providing an overview of the current regulatory testing requirements for VMPs and opportunities for implementation of the 3Rs (Link).

Outstanding documents will be published on the EMA website in due course.

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