In addition to the CVMP minutes of November (Link) and December (Link), the EMA has published updates relating to the following topics:
IMMUNOLOGICALS
- Report on the Focus Group meeting with invited stakeholders on field efficacy trials in the context of an EU authorisation for veterinary vaccines (Link)
- Recommendations from the Joint EMA/HMA Steering Group on veterinary vaccine availability (Link)
- AVC Presentation - Challenges in performing field trials to support efficacy: companion animal vaccines (Link)
REGULATORY PROCEDURES
- Procedural advice to applicants/marketing authorisation holders on re-examination of CVMP opinions (Link)
- Updated: Member states contact points for translation review (v.6.9) (Link)
- EMA-HMA BPG Measures to Improve Predictability of Submissions (Link)
- New Q & As:
- What logos / symbols can be included on the outer packaging of my VMP? (Link)
- Type II variations: Introduction of a new manufacturing site for an active substance. What changes are covered by a single type II scope (Classification category B.I.a.1)? (Link)
- Type II variations: What changes to the product information (PI) can be included as part of one type II variation? (Link)
- Type 1B variations: When applying for a new pack size, what is considered within the range/outside the range (classification category B.II.e.5)? (Link)
NOVEL THERAPIES
- ADVENT – Allogenic mesenchymal stem cell-based products for veterinary use: specific questions on tumorigenicity (Link)
PHARMACOLOGY
- Draft guideline on conduct of pharmacokinetic studies in target animal species - Revision 1 (Link)
PHARMACOVIGILANCE
- Q & A on Management and Assessment of PSURs (Link)
- Q & A on Adverse Event Reporting (Link)