Although the EMA is currently operating under business continuity measures to safeguard core activities due to Brexit disruption, which could impact upon the implementation of important new medical device and veterinary legislation, they plan to re-examine their list of suspended activities in June 2019 and begin reintroducing them if appropriate.
With regards to Brexit-induced medicinal supply shortages, the Board were pleased to report that the number of medicines deemed to be risk were decreasing due to the proactivity of industry, and that potential exemptions to rules regarding batch testing could further decrease this number if implemented. The EMA have also published a Q&A document for patients, healthcare professionals and the general public to inform them on the work they are doing to prevent such shortages.
The Board also discussed the EMA’s 2018 Annual Report, which is due to be published between April-May 2019; despite Brexit disruption, they recommended the authorisation of 84 new medicines for human use (42 of which contained new APIs) and 10 for veterinary use (4 of which contained new APIs).
The Board were informed of progress regarding the Clinical Trials Information System (CTIS), which is due to enter agile development in June 2019.
For further information, please read the EMA’s full press release here.