One of the big topics in the June meeting of the management board of the European Medicines Agency (EMA) was, not surprisingly, an update for the board on the agency’s preparation for the withdrawal of the United Kingdom from the European Union (EU). Preparatory work is being carried out along several work streams, including:
- Physical relocation of the EMA from London to one of the remaining 27 EU member states.
- Redistribution of the workload relating to the evaluation and monitoring of medicines to ensure the high quality of EMA’s scientific assessments and compliance with legal timelines. The board endorsed the mandates of two working groups, one focusing on human medicines and one on veterinary medicines.
- Provision of guidance and information to pharmaceutical companies to ensure they are ready to take the necessary steps to enable undisrupted supply of their medicines for the benefit of patients.
A business continuity plan on EMA Brexit preparedness was presented to the board.
Other areas of work highlighted by the board included the launch of PRIME (PRIority MEdicines), an initiative to enhance support to medicines that target unmet medical needs, the launch of a website for the proactive publication of clinical data for new medicines, the conclusion of a pilot on parallel scientific advice with health technology assessment bodies and global response to the threat of antimicrobial resistance.
In addition, the board discussed the progress made regarding the development of the EU clinical trial portal and database. Due to technical difficulties with the development of the IT systems, the portal’s go-live date has to be postponed. EMA is working closely with its IT service provider to ensure that corrective measures are implemented and will closely monitor progress.
The EU clinical trial portal and database supports the ambitious modernization of the processes for authorization and oversight of clinical trials in the EU laid down in the EU Clinical Trial Regulation. The system will provide a single portal for submission and maintenance of clinical trial applications and authorizations, and support coordinated assessment and supervision. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU, from their initial review up to the publication of their results.