Minutes of the CVMP Meeting 10 -12 April 2017 published

18 April, 2017

The EMA has posted the press release with details of the CVMP's meeting of 10 -12 April 2017 (Link). General news relating to regulatory affairs are summarised below, with links to those adopted documents which are now available online:

Draft guidance released for consultation

  • EFFICACY: draft revised guideline on the conduct of bioequivalence studies for VMPs (Link)

Guidance adopted

  • IMMUNOLOGICALS: revised guideline on data requirements for immunological VMPs intended for minor use or minor species (Link), with overview of comments (Link).
  • EFFICACY: reflection paper on anthelmintic resistance (Link), with overview of comments (Link)
  • PHARMACOVIGILANCE: Updated Q & A – Serious non-fatal adverse events and reporting rules (Link)
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