The Management Board heard an update on recent activities in response to the pandemic. The Board was updated on the status of the Agency’s ongoing COVID-19 lessons learned exercise. As part of this exercise, some of the measures and actions taken by EMA and the network in response to the pandemic are being discussed and reflected upon across a number of areas. Over the next few months, the Agency will discuss its findings and recommendations with the network in collaboration with the Heads of Medicines Agencies (HMA). The Board will be updated in December.
Face-to-face scientific committee meetings will be relaunched from the end of October, as a pilot, alternating on-site with remote meetings on a monthly basis.
Mid-year report 2021 adopted
The Agency’s report of activities in the first half of 2021 shows that requests for scientific advice for human medicines increased in the first six months of 2021 compared to the same period in 2020 predominantly due to many developers seeking advice for their COVID-19 vaccines and treatments. EMA received 46 requests for advanced therapy medicinal product (ATMP) classification in the first six months of 2021. Significant efforts were devoted to tackling vaccine hesitancy in the first half of 2021, including extensive public communication, webinars, and information on the EMA website on COVID-19 vaccines. The mid-year report will be published on the EMA website shortly.
Progress on EU IT systems required by the Clinical Trial Regulation
The Clinical Trial Regulation will come into application and the Clinical Trial Information System (CTIS) will go live on 31 January 2022. The Board noted the progress in the development and preparations for ‘go-live’ of CTIS and the CTIS global go-live plan. The CTIS functionalities, agreed for the go-live release, have been delivered and the focus is now on stabilising the system. EMA is providing tools and support to Member States and sponsors, and their staff, to facilitate preparations for go-live. CTIS is the cornerstone for application of the CTR. Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring.