Recent news from the CVMP includes developments in CMC, AMR, ERAs and regulatory submissions

Antimicrobial resistance (AMR) news from European Medicines Agency (EMA)
19 February, 2019

While the February meeting of the CVMP takes place this week, the EMA has posted the press release with details of the CVMP's meeting of 22-24 January (Link).  The press release gives overview detail on procedure outcomes for Centrally Authorised VMPs, a list of recent MUMS classifications, and updates on activities of some of the working parties. Regulatory news from the CVMP January meeting and other recent updates include the items discussed below:

Quality / Chemistry, Manufacturing and Controls (CMC)

The Committee adopted the revised mandate, objectives and rules of procedure for the joint CHMP/CVMP Quality Working Party following its adoption by CHMP in December 2018. This document is available on the EMA website via the QWP page (Link).

Environmental Risk Assessments (ERAs)

The Committee also adopted the revised mandate, objectives and rules of procedure for the Environmental Risk Assessment Working Party. The updated version is published on the ERAWP web page (Link).

Antimicrobial Resistance (AMR)

The Committee adopted a revised draft scientific advice on the categorisation of antimicrobials, in response to a request from the Commission. The advice was also adopted by CHMP at their January 2019 meeting, and is released for public consultation until 30 April 2019. The consultation and related documents are available on the EMA website (Link).

Regulatory submissions

  • The EMA has prepared a guidance document for Applicants using the variations eAF for Type IA and Type IB variation procedures.  The guidance contains annotated pages from the eAF for ease of reference (Link).
  • The latest updates to the veterinary eAFs, including bug fixes, have been implemented in version  Use of this version will become mandatory from April 4th 2019 (Link).
  • The December 2018 Monthly report from the EMA on application procedures, guidelines and related documents for veterinary medicines has been published on 6th February 2019 (Link).




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