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:
Other recent news from the EMA, outside of the CVMP meeting minutes, is summarised below.
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.
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”).
The EMAs strategic reflection on regulatory science to 2025 has now been published (Link).
Implementation of risk assessment requirements to control elemental impurities in VMPs (Link).
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).
The January report on application procedures, guidelines and related documents for VMPs has now been published (Link).
The EMA has published is annual report on MUMS, this year celebrating achievements over the last 10 years (Link).