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Draft guidance released for consultation: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.
