The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 January 2016 (Link). General news relating to regulatory affairs includes:
- Community referral (Article 35): the Committee started a procedure for all VMPs containing gentamycin presented as solutions for injection for cattle and pigs, due to concerns relating to withdrawal periods.
- Four draft revised guidelines on data requirements for VMPs intended for MUMS/limited market (quality, safety, efficacy and immunologicals) were adopted for consultation.
- A draft concept paper for the revision of the guideline for the conduct of pharmacokinetic studies in target animal species was adopted for consultation.
- A revised guideline for the demonstration of efficacy for VMPs containing antimicrobial substances was adopted for consultation.
The above guidance documents will be published on the website of the EMA in due course.