Following three years of relocation and workforce changes, the European Medicines Agency has outlined the challenges to come, in its December Management Board meeting.
A major discussion centred around the European Union (EU) cooperation on medicines’ availability. The EU single point of contact (SPOC) system was piloted to the test the usefulness of information exchange regarding important shortages of medicines between Member States (MS), EMA and the European Commission (EC). SPOC would also allow MSs to share information on alternative medicines that could be used in the event of a shortage in other MSs, helping to prevent and manage shortages. After a successful first phase, the second phase is expected to be rolled out in 2020, however, the EMA Management Board emphasised that the necessary resources must be made available by national authorities in MSs.
The meeting also included an update on the incoming Clinical Trial Regulation (CTR). The Board noted the good progress in development of the Clinical Trial Information System (CTIS), which was a key factor in the delay of CTR rollout. An audit of the system will be carried out in December 2020, which will allow enough time for the product owners to develop or fix any outstanding items.
The ongoing review into nitrosamine impurities was another key topic for discussion. The mandatory use of the international standard for reporting suspected side effects of medicines was also highlighted. Other highlights included, the HMA-EMA Joint Big Data Taskforce Report, key principles of electronic product information (ePI) and the EMA budget for 2020.
For further detail on the EMA’s focus for 2020, click here.