Minutes of CVMP November 2017 meeting published

10 November, 2017

The EMA has posted the press release with details of the CVMP's meeting of 7 – 9 November 2017 (Link). General news relating to regulatory affairs includes:

Draft guidance released for consultation:

  • Guideline on pharmacokinetic studies in target animals

Guidance adopted:

  • Novel therapies – Questions and Answers to address the topic of tumorigenicity for the development of stem cell-based products for veterinary use
  • 3Rs – guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs, together with the overview of comments
  • Pharmacovigilance – two separate Question and Answer documents to address the topics of preparation, management and assessment of PSURs and adverse event reporting
  • Regulatory – revised procedural advice to applicants/marketing authorisation holders on the re-examination of CVMP opinions

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

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Unparalleled Expertise for EU Centralised Procedures

Cyton has a strong collaborative working relationship with Dr. Anja Holm of CVPC, former chair of the CVMP.

As well as providing unique insights into our clients' projects, our collaboration with Dr. Holm also includes regulatory training courses. Follow the links below for more information.
- Central VetPharma website
- Training event: Innovative VMPs