The EMA has published the minutes of the latest CVMP meeting (link). The following general regulatory developments are noted:
- A revised guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats was adopted for consultation (link)
- A draft reflection paper on poorly extractable and/or non-radiolabelled substances was adopted for consultation (link)
- A reflection paper on promotion of pharmacovigilance reporting was adopted (link)
- Priority topics for which guidance will be developed by ADVENT in the first instance were agreed as below and the work plan for ADVENT in 2015 was endorsed (link);
- products containing stem cells
- products containing monoclonal antibodies
- tumour vaccines intended for use in animals (yet to be confirmed)
- Two VICH guidelines were adopted following sign-off by the VICH steering committee
- VICH GL53: Guideline on electronic exchange of documents: electronic file formats, for implementation (link)
- VICH GL54: Guideline on studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD), for public consultation (link).
Published by the EMA on the same date was ESVAC's “Principles on assignment of defined daily dose for animals (DDDA) and defined course dose for animals (DCDA)” for consultation (link), for the purpose of drug consumption studies.