EMA updates on PV, stem cells, eSubmissions, the new VMR, GMP and CMC.

The EMA has posted the press release with details of the Committee for Medicinal Products for Veterinary use - CVMP - meeting of 14 – 16 July 2020 (Link). General news from the plenary meeting and other updates from the EMA relating to regulatory affairs  are summarised below, with links to all the source document, where available.

Pharmacovigilance (PV)

The Committee adopted an update to Q & As on adverse event reporting, with additional guidance on identifiable sources for social media reports - see Q10. (Link).

Novel therapies

The CVMP adopted Q & As on the evaluation of target animal safety for stem cell products for veterinary use (Link).

eSubmission

The EMA has issued a reminder that Version 1.24.0.0 of all electronic Application Forms is planned for release in September 2020 with mandatory use from November 2020 (Link).

The new Veterinary Medicines Regulation (EU) 2019/6

• The first of the Veterinary Medicines Regulation (VMR) highlights newsletters, to be published quarterly going forwards, provides key updates on the implementation of the VMR (Link).
• The CVMP adopted a "scientific problem analysis and recommendations to ensure a safe and efficient oral administration of VMP via routes other than medicated feed" (not yet published).
• The CVMP adopted a concept paper for a reflection paper on criteria for the application of Article 40(5) of the VMR for consultation, regarding additional protection of technical documentation (Link). 
• The draft Union Product Database (UPD) Access Policy has been published for consultation until 18th September (Link).

Good Manufacturing Practices (GMP)

The EMA’s pre-submission guidance for VMPs has been updated with a new Q & A concerning information to be provided with the marketing authorisation application regarding GMP compliance (Link – Q40).

Chemistry, Manufacturing and Controls (CMC)

Quality of water for pharmaceutical use – updated guidance and overview of comments now published (Link).

Monthly reports

• June 2020 report on application procedures, guidelines and related documents for VMPs (Link).
• July 2020 update of the PV regulatory recommendations for centrally authorised VMPs, tracking the PV actions, such as SPC changes (Link).