EMA on Brexit: Risk for Drug Shortages Decreases

Regulatory NewsRegulatory News | 22 March 2019 |  By 

As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”
The board said the risk has gone down because more companies have taken the necessary steps to ensure that their medicines can remain on the market. EMA last September said the number of centrally authorized medicines for which there are concerns of Brexit-related supply disruptions declined from 108 to 39 (25 human medicines and 14 veterinary medicines).
“Work is still ongoing with national competent authorities to verify availability and identify alternatives at national level,” EMA said.
Last month’s exemption to certain batch testing requirements for drugmakers that currently perform batch testing in the UK “may also lower the number of products currently considered as critical and at risk of supply shortages, provided that eligible companies make use of the new available measure and the exemption is granted. The Agency is currently reviewing the requests for exemptions,” EMA said.
And the agency warns that if the UK were to leave the EU without any agreement, there is is still a high risk of supply issues with some medicines.
As far as the latest on the Brexit extension the European Council explained Friday that if “the withdrawal agreement is approved by the House of Commons by 29 March 2019 at the latest, the extension will be until 22 May 2019. In the event that the withdrawal agreement is not approved by the House of Commons by 29 March 2019, the extension will be until 12 April 2019. In that event, the UK will indicate a way forward before 12 April 2019, for consideration by the European Council.”
EMA still needs time to rebuild its workforce and focus on core activities related to the evaluation and supervision of medicines, following the shift from London to Amsterdam. The agency said this work may impact its ability to implement certain pieces of legislation, such as the medical devices legislation, the veterinary legislation and the General Data Protection Regulation (GDPR).
“At its next meeting in June 2019 the Board will discuss a list of temporarily suspended or reduced activities which could be gradually restored as a priority,” EMA said.
EU Clinical Trial Regulation
EMA also gave an update on the development of its Clinical Trials Information System as part of the clinical trial regulation, noting the project plan has been revised “to improve delivery and to ensure that stakeholders can give feedback more regularly.
“The contract for the delivery of the system has been restructured, so that the code of the safety reporting can be merged with EU clinical trial portal and database system modules, key bug fixing can be carried out and the system can then enter a phase of iterative, agile development as of June 2019. This approach will support the further enhancement of the system, in close interaction with the user community, through the audit and until after the system has gone live and the Clinical Trial Regulation has entered into application,” EMA said.
EMA Management Board: Highlights of March 2019 Meeting


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Tags: Brexit, EMA, shortages

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