Following the agreement between the United Kingdom (UK) and the European Union (EU) to extend the Brexit deadline, during the European Medicines Agency’s (EMA) Management Board meeting in Amsterdam they stated that the prospect for centrally authorised products to be at risk of shortage “continues to decrease”. However, the agency has warned that if the UK were to leave the EU with no-deal, then there is still a high risk of supply issues with some medicines.
The Management Board explained that the risk has decreased because a greater number of companies have taken the necessary steps to ensure that their medicines can remain on the market. The EMA have said that “work is still ongoing with national competent authorities to verify availability and identify alternatives at national level”. In September 2018, the EMA stated that the number of centrally authorised medicines for which there are concerns of Brexit-related supply disruptions had decreased from 108 to 39 (25 human medicines and 14 veterinary medicines).
The announcement of the exemption to certain batch testing requirements for drug manufacturers 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.”
The latest on the Brexit extension is that if the withdrawal agreement is approved by the House of Commons by 29th March 2019 at the latest, the extension will be until 22nd May 2019. However, if the withdrawal agreement is not approved by the House of Commons by 29th March 2019, then the extension will be until 12th April 2019. In this case, the UK will indicate a way forward before 12th April 2019 for consideration by the European Council.
The EMA have stated that they still need time to rebuild their workforce and are focusing on core activities related to the evaluation and supervision of medicines, following the move from London to Amsterdam. The work may impact the EMA’s ability to implement several legislations, such as the medical devices legislation and General Data Protection Regulation (GDPR).
At the Management Board meeting, the EMA also discussed the EU Clinical Trial Regulation and the development of their Clinical Trials Information System. The EMA have stated that 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.”
To read the highlights of the March 2019 EMA Management Board meeting, please click here.