How is the current situation with The EMA?
This is the first meeting of the Board since the General Affairs Council (Art.50) of 20 November and the decision of the EU 27 Member States to relocate the Agency to Amsterdam. EMA now has just over 15 months to prepare for the move and take up its new seat in Amsterdam by 30 March 2019 at the latest.
EMA’s collaboration with the Netherlands commenced promptly and agreement has been reached on the joint governance structure with plans to progress activities within five work streams relating to the temporary and permanent premises, staff relocation, financial and legal aspects, and external communication.
The EU27 Member States and EMA have developed a methodology for the redistribution of the work currently carried out by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD). The joint redistribution plan reflects the strengthened capacity of the European medicines regulatory network. The risk-based methodology takes into account the diverse expertise in the network and the workload associated with the medicines. EMA will communicate details of the methodology and next steps in early 2018.
What will be the 2018 work programme and budget for the EMA?
The EMA is preparing the UK’s withdrawal from the EU an what will be the impact on the activities of the Agency. This became clear in the discussion on the Agency’s work programme and the budget for 2018-2019.
The Board adopted a budget of 337 million euros for 2018, a 2% increase over the previous year, driven primarily by an increase in fee-generating activities. The budget for 2018 includes provisions for Brexit-related costs such as IT-related relocation expenses and costs of the physical relocation of the Agency staff and assets. As the relocation process evolves, the budget will need to be monitored carefully and any additional costs that cannot be absorbed should be discussed with the European Commission.
How is going the development of the EU clinical trial portal and database for the EU Clinical Trial Regulation?
The development of the EU Portal and Database is making important progress. A partially-completed version of the system has been subjected to user acceptance testing by representatives of the European Commission, Member States, academia, pharmaceutical industry and contract research organisation (CRO) associations throughout November, while technical testing and further development continue in parallel.
This is the most ambitious IT development project so far required by the EU pharmaceutical legislation. The Agency is working hard in collaboration with Member States, stakeholders and the developers to deliver a good, functional system to support the needs of EU clinical research, and to have the Clinical Trial Regulation enter in operation as soon as practicable.