Highlights of Management Board – October 2021 meeting

The Management Board heard an update on recent activities in response to the pandemic. Since the last update in June, EMA has started a rolling review procedure for another vaccine for COVID-19 and approved some important labelling changes for the authorised mRNA vaccines to cover younger age groups, extra doses for people with severely weakened immune systems and boosters for the general population. New manufacturers have been approved for all authorised vaccines, enabling an increase in their supply capacity. A marketing authorisation application review procedure has started for a monoclonal antibody product and reviews are progressing well for three monoclonal antibody treatments and three immunomodulators.

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 including support for rapid research and development, rapid authorisation procedures, safety and effectiveness monitoring post-authorisation, workload and resourcing, and transparency and communication on COVID-19-related issues. 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. The Board adopted a change to its rules of procedure to allow virtual meetings of the Board also in non-emergency situations and to allow meetings in person and virtually during emergency situations. The Board endorsed similar changes to the rules of procedure for EMA’s scientific committees.

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 (454 vs 377). This is predominantly due to many developers seeking advice for their COVID-19 vaccines and treatments.

There is also an active pipeline of new advanced therapy medicines which are expected to reach the marketing authorisation application stage in the next few years. EMA received 46 requests for advanced therapy medicinal product (ATMP) classification in the first six months of 2021. Although this number is lower than the number of requests received in the first six months of 2020 (54), it is substantially higher compared to the same period in 2017, 2018 and 2019.

The number of new initial evaluation applications for human medicines received in the first half of 2021 were lower than in 2020 (49 vs 65 in the first half of 2020). In particular, applications for new orphan medicines fell (10 vs 17 in the first half of 2020). This, however, could be a normal fluctuation as applications are typically not spread out evenly over the year.

In veterinary medicines, initial evaluation applications fell from seven in the first half of 2020 to four in the first half of 2021. This downward trend could be linked to decisions of pharmaceutical companies to submit their applications only when the new provisions foreseen by the new Veterinary Medicines Regulation become effective in 2022. A substantial increase was seen in the number of variations submitted post-authorisation for veterinary medicines.

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. This follows the publication of the Commission decision on 31 July 2021 in the Official Journal of the European Union. The Board noted the progress in the development and preparations for ‘go-live’ of CTIS and the CTIS global go-live plan . The Board endorsed the joint controllership arrangement for the processing of personal data when using CTIS, that has been negotiated and agreed between representative groups of CTIS users.

The CTIS functionalities, agreed for the go-live release, have been delivered and focus is now on stabilising the system. The developer together with EMA, Member States, sponsor and Commission experts are testing the system in October to identify any potential remaining issues that would need to be resolved prior to go-live.

EMA is providing tools and support to Member States and clinical trial sponsors, and their staff, to facilitate preparations for go-live, including registration of CTIS administrators, support in Member State and sponsor organisation configuration planning, an extensive online training programme, information events and the publication of supportive documentation such as the CTIS sponsor handbook . 

CTIS is the cornerstone for application of the Clinical Trial Regulation. Clinical research and patient health in the EU will benefit from the streamlined regulatory processes that the Regulation and CTIS will bring. It is important that clinical trial sponsors and authorities prepare their staff and processes to work with CTIS and deliver the benefits of the Clinical Trial Regulation.