The October 2020 meeting of the Management Board focused in particular on the Agency’s activities in response to the COVID-19 pandemic. The meeting was Guido Rasi’s final Board meeting as EMA’s Executive Director before Emer Cooke takes the helm in mid-November.
Update on COVID-19 activities
The Management Board was updated that the first ‘rolling review’ of data on a COVID-19 vaccine started.
The safeguards to secure the robustness and independence of the scientific review process for marketing authorisation applications for COVID-19 therapeutics and vaccines were discussed by the Board. This was also subject to a recent enquiry from the European Ombudsman. The importance of addressing perceptions of potential bias in the context of the unprecedented efforts that are being made to develop vaccine candidates was raised by EMA. Measures have been introduced to ensure that the scientific review process of marketing authorisation applications for COVID-19 vaccines and the EU vaccine purchasing procedure under the Advance Purchasing Agreements (APAs) remain separate processes. This means, for instance, that scientific committee members and experts involved in the licensing procedures cannot take part in the EU advance purchasing procedures and vice versa.
The Board heard that there is a need to prepare for a sharp rise in marketing authorisation applications for COVID-19 therapeutics and vaccines in Q4 2020 and Q1 and Q2 2021. The Agency has invoked its business continuity plan (BCP) to cope with the initial wave of COVID-19-related work which will impact on other activities performed by the Agency. The Board will be informed at its December meeting on the consequences for 2021. In addition, in the longer term, the unprecedented increase in volume of work for post-authorisation follow-up of COVID-19 therapeutics and vaccines will also have to be carefully considered. EMA is already diverting resources away from other important European public health activities, e.g. drafting guidelines for product development. Additional resources are also required for communication activities and engagement with stakeholders on vaccines. The Board stressed that it is critical that extra resources are urgently made available to EMA to allow the Agency to fulfil its public health mandate and respond to patient needs in all disease areas.
Mid-year report 2020 adopted
The Agency’s report of activities in the first half of 2020 shows that the number of new initial evaluation applications for human medicines received in the first half of 2020 remained at a similarly high level as in 2019 (65 in the first half of 2020 compared to 63 in the first half of 2019) despite the disruptions caused by the COVID-19 pandemic.
In veterinary medicines, initial evaluation applications fell by 50% in the first half of 2020 compared to the first half of 2019. This is in line with the annual forecast as most applications are expected in the second half of 2020.
Requests for advanced-therapy medicinal product (ATMP) classification saw a notable increase, with twice the number of requests compared to the past three years (54 in the first six months of 2020 compared to 27 in the first six months of 2017, 2018 and 2019), which indicates an active pipeline of new advanced therapy medicines which are expected to reach the marketing authorisation application stage.
The mid-year report will be published on the EMA website shortly.
Update on the presence of nitrosamine impurities in medicines
In June 2020 the Agency published the report on lessons learnt from the presence of N-nitrosamine impurities in sartan medicines. The Board today endorsed a plan for the implementation of the recommended actions aimed at ensuring that regulators are better prepared to manage future cases of unexpected impurities. The plan is currently being reviewed by the Heads of Medicines Agencies (HMA). A table outlining the recommendations from the exercise, the lead/responsible party and the timeline for implementation will be published shortly. The Board will be informed of progress on an annual basis.
EU IT systems required by the Clinical Trial Regulation
The Board noted the progress in the development of the Clinical Trial Information System (CTIS) audit version which is on schedule for audit starting in November 2020. The first meetings with the independent audit team have taken place in preparation for the audit.
The group responsible for prioritising all outstanding issues to the CTIS governance and matching the items remaining after the audit to the capacity available before and after go-live has been established and has made good progress. This group includes representatives from Member States and sponsors, as well as EMA and the European Commission. For the purpose of the prioritisation exercise, as a working assumption, the go-live date of CTIS remains December 2021.
Update on the European Medicines Agencies Network Strategy to 2025
The Board heard an update on the extensive and encouraging feedback received from stakeholders as part of the public consultation on the European Medicines Agencies Network Strategy to 2025. Over 175 comments were received from a broad range of stakeholder groups. This feedback is currently being incorporated into the strategy, which is due to be finalised in November.
Review of activities of EMA’s working parties
A review of EMA’s working party activities is ongoing. The aim of the revision is to introduce a rational architecture and governance model that serves the expertise needs of the European medicines regulatory network in its public and animal health mission with sufficient agility and adaptability to respond to future scientific and technological strategic challenges.
Having adopted a set of high-level guiding principles and core recommendations at its March 2020 meeting, the Board was informed of steps taken to implement changes both in the veterinary and human areas. These include developing three-year workplans in line with EMA’s Regulatory Science Strategy to 2025, a reflection on the expertise needs and consequent revision of the architecture and composition of various working parties, together with the establishment of five principal ‘domains’ to govern the revised organisation of the working parties, i.e. quality, safety, methodology, clinical and veterinary. The topic will be discussed further at EMA’s December 2020 Board meeting.
Update on DARWIN EU (Data Analytics and Real World Interrogation Network)
The Board discussed plans to implement DARWIN EU, the EU platform for accessing and analysing healthcare data from across the EU. The Board noted that discussions were ongoing on funding the project phase from Commission programmes and the long-term maintenance through EMA fees. The Board will discuss more detailed project planning, including resourcing, at its December 2020 meeting.
Other updates
The October 2020 meeting of the Management Board was Guido Rasi’s final Board meeting as EMA’s Executive Director before the end of his mandate. The Chair of the Board, Dr Christa Wirthumer-Hoche, thanked Professor Rasi on behalf of the Board for his leadership of the Agency over the last nine years and for successfully charting the Agency’s course through the challenges of the past few years. Guido Rasi will remain in his role until 15 November after which Emer Cooke will become the Agency’s new Executive Director.
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