The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 February 2016 (Link). General news relating to regulatory affairs includes: - The Committee started a procedure for all orally administered VMPs containing zinc oxide for food producing species, due to concerns related to potential risk to the environment and increase of prevalence of antibiotic resistant bacteria
- In response to the EC’s request for updated advice regarding the use of colistin in animals, the Committee agreed a timetable for the update
- The Committee adopted a revised draft guideline for consultation, on the conduct of efficacy studies for intramammary products for use in cattle
- The Committee adopted a new reflection paper for consultation, on the authorisation of VMPs containing (potential) Persistent Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) substances
- The Committee adopted a draft guideline for consultation, on the sterilisation of the medicinal product, active substance, excipient and primary container
- The Committee adopted a new reflection paper for consultation, on the chemical structure and properties criteria to be considered for the evaluation of New Active Substance (NAS) status of chemical substances
- The Committee adopted Questions and Answers (Q&A) on the following quality and efficacy/antimicrobials topics:
- On the data requirements for sterilisation processes of primary packaging material subsequently used in an aseptic manufacturing process
- A new Question and Answer relating to the SPC guideline for antimicrobials, in regard to suitable pack sizes for antimicrobials
- The Committee agreed for the release of two problem statements prepared by ADVENT on novel therapy topics for consultation. The problem statements provide the basis for development of guidance on the following novel therapy topics:
- Monoclonal antibodies intended for veterinary use
- Sterility in relation to stem cell products intended for veterinary use
- The Committee adopted two revised VICH guidelines for consultation:
- VICH GL50: Revised guideline on Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use
- VICH GL55: Revised guideline on Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use
The adopted documents will published on the EMA website in the coming weeks. |
