EU Veterinary Medicines regulatory news: Report of June CVMP meeting published

HorseMedicineEuropeNovelTherapyStemCell
22 June, 2018

The June meeting of the Committee for Veterinary Medicinal Products took place on 19th-21st June (Link to report page).

First veterinary stem cell product authorised in the EU
There were two positive opinions regarding MAAs for veterinary therapies, one of which was Arti-Cell Forte, a suspension for injection for horses intended for the reduction of mild to moderate recurrent lameness, which became the first stem cell-based veterinary medicine to be recommended for marketing authorisation in the EU.  Another stem cell product received a negative opinion.

Publications

Antimicrobials
The EMA adopted a reflection paper regarding use of aminoglycosides in animals in the EU (Link). The paper makes recommendations on how these medicines should be used in animals to maintain their effectiveness to treat infections in both humans and animals.

Pharmacovigilance
Updated Q&A document summarising queries received from stakeholders via the EudraVigilance support desk and as raised in instructional webinars, with responses from the EMA, relating to the new EudraVigilance system. The document (now version 1.5) is available to view here (Link to PDF).

Immunologicals
The EMA has drafted a guideline on veterinary vaccines containing adjuvants, on which consultation is now open until 15th January 2019 (Link).

Joint CVMP/CHMP Working Group on the application of the 3Rs (J3RsWG)

A reflection paper providing an overview of the current EU regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs has been adopted. The adopted paper and collated comments received are available on the EMA website (Link).

Combined Veterinary Dictionary for Drug Regulatory Activities (VeDDRA)

The VeDDRA list of clinical terms for reporting suspected adverse reactions to veterinary medicinal products in animals and humans has been updated. Refer to:

•    The list of changes (Link).
•    Updated document (Link).

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Will Drury Senior Business Associate
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