New Executive Director and veterinary developments at the EMA

The EMA has posted the press release with details of the CVMP's meeting of 16 – 18 June 2020 (Link). General news from the CVMP plenary relating to regulatory affairs and other recent news from the EMA is summarised below.

New EMA Executive Director

The EMA announced that Emer Cooke has been nominated as its new Executive Director (Link). 

Chemistry, Manufacturing and Controls (CMC) and Good Manufacturing Practice (GMP)

The Committee adopted a new guideline on water for pharmaceutical use (Link – not yet published).

The European Commission, EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting in June, which included discussion of the expansion of the current mutual recognition agreement on GMP to veterinary medicines by July 2022 (Link).

The New Veterinary Regulation (NVR)

The Committee adopted scientific recommendations for implementing measures regarding the format of the data to be collected on antimicrobial VMPs (Link).

The EMA has also published its advice on implementing measures regarding good distribution practices (GDP) for active substances used as starting materials in VMPs (Link).

Immunological Veterinary Medicinal Products (IVMPs)

The Committee adopted Q & As on management of extraneous agents in IVMPs (Link).

Veterinary antimicrobials strategy

The Committee adopted the draft CVMP strategy on antimicrobials 2021-2025 for a period of public consultation (Link).

Pharmacovigilance - annual VeDDRA review

Following adoption at the May CVMP meeting, the latest version of the VeDDRA terms for reporting AEs to VMPs is now available (Link).

Regulatory procedures

The revised implementing rules on fees payable to the EMA have now been published (Link). A simplified explanatory note has also been issued (Link)

The EMA report for May on application procedures, guidelines and related documents for VMPs is now published. As summarised at the end of the report, so far in 2020 there has been quality guidance on elemental impurities, ecotox guidance on PBT / vPvB substances and companion animal parasiticides and several pharmacovigilance updates

The EMA pre-submission Q & As have been updated with amendments concerning (Link):

• Q1/2 - centralised procedure eligibility
• Q3 - appointment of (co)rapporteurs
• Q40 - information to be included in a marketing authorisation application regarding GMP compliance.

CVMP July 2020

The July meeting of the CVMP is taking place this week (14–16 July) and the minutes will be published in due course (Link).