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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.
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.
VICH guidance has been adopted by CVMP for publication and implementation, relating to consumer safety:
Also in March and April, there have been a number of other developments at the EMA, as discussed below.
Following release of the latest versions of the eAFs, issues were identified with the forms and fixes were implemented, taking the current version to v18.104.22.168. Subsequently, further notes were published on the eSubmissions website regarding the correct use of the eAFs (Link).
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).