EMA adopts new VICH guidance as Veterinary Medicines Division welcomes new head of Surveillance and Regulatory Support

Committee for Medicinal Products for Veterinary Use (CVMP) March meeting

The EMA has posted the press release with details of the CVMP's meeting of 19 – 21 March 2019 (Link). General news relating to regulatory affairs includes the following.

Chemistry, Manufacturing and Controls

A new Q & A document was adopted on the use of peptone in the manufacture of active substances via fermentation process, following adoption by the CHMP. This is not yet published, but will be made available in the coming weeks.

MRLs and Consumer Safety

VICH guidance has been adopted by CVMP for publication and implementation, relating to consumer safety:

• GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species (Link).
• GL36(R2) on microbiological ADI: VICH GL36 (R2) on general approach to establish a microbiological ADI (Link).

Also in March and April, there have been a number of other developments at the EMA, as discussed below.

eSubmissions and electronic Application Forms (eAFs)

Following release of the latest versions of the eAFs, issues were identified with the forms and fixes were implemented, taking the current version to v1.23.1.2. Subsequently, further notes were published on the eSubmissions website regarding the correct use of the eAFs (Link).

Latest EMA Brexit updates

The EMA Brexit landing page has been updated, with advice to industry to continue making the necessary preparations for Brexit, ready for the new withdrawal date of 31 October 2019 (Link). Prior to the news of the delayed withdrawal date, a new Q & A document was also published, regarding EU actions to prevent medicine shortages due to Brexit (Link).

Other Regulatory Updates and Reports

• The latest monthly report (for January 2019) on application procedures, guidelines and related documents for veterinary medicines has been published (Link).
• The 9^th Annual Report on MUMS/limited market scheme for veterinary medicines is now available (Link). This includes an overview of changes in the guidance and policy for MUMS / limited market products.
• A new webpage “Search Tips” has been published to help navigate the EMA website more effectively (Link).
• The Veterinary Medicines Division has updated its organisation chart, following the start of Barbara Freischem as head of the “Surveillance and Regulatory Support Department” (Link).