Minutes of CVMP September 2017 meeting published

The EMA has posted the press release with details of the CVMP's meeting of 5 – 7 September 2017 (Link). General news relating to regulatory affairs includes:

Draft guidance released for consultation

• IMMUNOLOGICALS: Revised guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza (AI), bluetongue (BT) and foot-and-mouth disease. The Committee also adopted Questions and Answers to address the topics raised by stakeholders that are not specifically addressed within the revised guideline itself.

Guidance adopted

• ANTIMICROBIALS: Joint ECDC, EFSA and EMA scientific opinion on a list of outcome indicators as regards surveillance of antimicrobial resistance and antimicrobial consumption in humans and food producing animals.

The adopted documents will be published on the EMA website in the coming weeks.