Minutes of CVMP Meeting 14 – 16 June 2016 published

The EMA has posted the press release with details of the CVMP's meeting of 14 – 16 June 2016 (Link). General news relating to regulatory affairs includes:

Quality guidance

• A Questions and Answers document was adopted, on Product specific active substance information.

Safety guidance

• A draft guideline was adopted for consultation, on user safety of topically administered VMPs.

Pharmacovigilance guidance

• The latest VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to VMPs was adopted, following the yearly review and update.

ADVENT

• A new problem statement was agreed by the CVMP Ad hoc Expert Group on Novel Therapies (ADVENT) on stem cells for veterinary use, regarding specific questions on extraneous agents.

Governance

• The Committee elected Dr David Murphy from Ireland as Chair for a three-year mandate
• The Committee re-elected Dr Rory Breathnach as chair of the Scientific Advice Working Party (SAWP-V) for a three-year mandate.

The adopted documents will be published on the EMA website in the coming weeks.