COVID-19 forces first remote CVMP plenary, but work at EMA continues with updates on the VMR, CMC, PV, eSubmissions and MUMS

The EMA has posted the press release with details of the CVMP's meeting of 18 – 20 February 2020 (Link) and the meeting of 17 – 18 March 2020, which was the first to be held entirely remotely, due to COVID-19 (Link). The February meeting discussed only product specific matters, with no new guidance adopted. General news relating to regulatory affairs from the March meeting included:

• The adoption of the 2019 annual pharmacovigilance bulletin (Link - the new report will be published here in the coming weeks).
• The EMA issued a reminder to marketing authorisation holders and Applicants that general regulatory enquiries should not be sent to the vet applications email address (vet.applications@ema.europa.eu). From April, general regulatory enquiries sent to this email address will not receive a reply and such enquiries will need to be re-submitted using the Ask EMA web form (Link).

Other recent news from the EMA, outside of the CVMP meeting minutes, is summarised below.

The new Veterinary Medicines Regulation

The European Commission has issued its mandate to the EMA for the “Implementing measures under Article 107(6) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the establishment of a list of antimicrobials, which shall not be used in accordance with Articles 112, 113 and 114 or which may be used in accordance with these articles subject to certain conditions” (Link). The EMA’s recommendation is expected after the February 2021 meeting of the CVMP.

eSubmissions

VNeeS guideline v2.7 is now available, as clean and tracked changes documents, in preparation for coming into effect 01Oct20 (Link – see under “Future Guidance”).

Regulatory Science

The EMAs strategic reflection on regulatory science to 2025 has now been published (Link).

Chemistry Manufacturing and Controls (CMC)

Implementation of risk assessment requirements to control elemental impurities in VMPs (Link).

Pharmacovigilance

Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission (Link).

The latest version of the VeDDRA list of clinical terms for reporting AEs in animals and humans to VMPs has now been published (Link).

EMA monthly report

The January report on application procedures, guidelines and related documents for VMPs has now been published (Link).

Minor Uses and Minor Species

The EMA has published is annual report on MUMS, this year celebrating achievements over the last 10 years (Link).