The EMA has posted the press release with details of the CVMP's meeting of 12 – 14 July 2016 (Link). General news relating to regulatory affairs includes:
Governance
- The Committee elected Helen Jukes from UK as its vice-chair for a 3-year mandate.
Community referrals
- Finland initiated an Article 35 referral for VMPs containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp, due to concerns relating to efficacy.
Draft guidance released for consultation
- QUALITY: Draft reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances.
- SAFETY: Draft guideline on approach towards harmonisation of withdrawal periods.
- ERAs: Draft guideline on the higher tier testing of VMPs to dung fauna
- EFFICACY: concept paper for the revision of the Guideline on anticoccidials for the therapy of coccidiosis in chickens, turkeys and geese
- AMR: concept paper for revision of the current guideline on the summary of product characteristics for antimicrobial products
- Replacement, refinement, reduction of animal testing (3Rs): draft guideline for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs
Guidance adopted
- ERAs: revision of the Q & A document in support of the guidance on the implementation of CVMP Guideline on Environmental Impact Assessment for VMPs in support of VICH GL6 (Phase I) and GL38 (Phase II)
- EFFICACY: revised guideline on the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats and the overview of comments
- AMR: updated advice on the use of colistin in animals within the EU (EMA/231573/2016) prepared by the AMEG
- PHARMACOVIGILANCE: Q & A on “Expressing the frequency of adverse reactions within the product information”
- NOVEL THERAPIES: two problem statements prepared by ADVENT on stem cell-based products for veterinary use
- Specific questions on tumorigenicity
- Specific questions on target animal safety
- PRODUCT INFORMATION: Q & A on mentioning solvents in the product information of centrally authorised VMPs
The adopted documents will be published on the EMA website in the coming weeks.
Also published by the EMA this week was updated guidance for requesting MUMS classification (Link) and for requesting scientific advice (Link), together with an updated template letter of intent to request scientific advice (Link).
