News updates from EMA during November and December

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)