The EMA has posted the agenda and meeting highlights from the CVMP meeting of 8-10 November. In other general news, EMA’s annual ESVAC report for 2021 shows an ongoing trend of decreasing antimicrobial use in food-producting animals in the 31 European countries; sales of antibiotics for animal use have almost halved between 2011-2021. Sales trends for each country included in the monitoring are published separately.

EMA/CVMP

CONSULTATIONS

• A draft guideline on development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy has been published for consultation. Comments are invited until 28th February, 2023.
• A draft reflection paper has been published for consultation, on the application of Regulation 2019/6 for certain categories of variations (Article 40(5) ). Comments are invited until 28th February 2023.

Pharmacovigilance

EMA has published new guidance and resources on Pharmacovigilance inspections for veterinary medicines, including:

• The Union procedure on the preparation, conduct and reporting of EU veterinary pharmacovigilance inspections;
• Union guidance on record keeping and archiving of documents obtained or resulting from pharmacovigilance inspections
• A Pharmacovigilance Inspection Report template;
• A template for collecting information on Pharmacovigilance issues for attention of inspectors and assessors.

administrative and regulatory reference documents

• The EMA has re-published the veterinary QRD product information template v.9 in all languages. The new edition will be version 9, corr. 11/2022. The templates and all related documents are available on the EMA’s updated webpage for veterinary PI;
• The submission deadlines and procedure timelines for veterinary SA procedures in 2023 are available for reference by applicants;
• The EMA has published the agenda, presentation slides and video from the webinar on VNRA submission via the UPD, that took place on 8th September. These items are available via the event page;
• An updated guide to IRIS registration and request of RPIs has been published by EMA (version 2.10);
• The Out-of-Scope for MRL list has been updated (version 56);
• The presentations and a video recording of the second Veterinary Big Data Stakeholder Forum, that took place on November 23rd, have been made available on the event page.

HMA/CMDV

The Report for Release of the CMDv meetings that took place in October and November 2022 has been published. As well as the usual updates on ongoing and completed regulatory procedures, the report also mentions discussion of the SPC Harmonisation exercise, with a product list being prepared in December and its expected adoption in final form in February 2023.

CMDv have also published a number of revised versions of key reference documents:

• A third edition of the CMDv Best Practice Guide for VNRAs was published in November;
• Clock Start dates for MRP-SRP, 2022-2023;
• Clock Start dates for DCP Phase II, 2022-2023;
• The CMDv review procedure (according to 2019/6) has been updated.