COVID-19 update
The Management Board heard an update from EMA on its COVID-19 activities. Boosters have become a very important tool in the response to the pandemic and EMA has now given recommendations for booster doses for the COVID-19 vaccines from Biontech/Pfizer, Janssen and Moderna. Recently, EMA and the European Centre for Disease Prevention and Control (ECDC) published findings of a review of academic and other studies on mix and match approaches in primary vaccination and for booster shots. The evidence shows that the use of two different COVID-19 vaccines for initial courses and boosters in general confers at least as much, in some cases even more, protection as when the same vaccine is used.
EMA reported on the recent extension of the COVID-19 vaccine Comirnaty to children from 5 to 11, and its ongoing evaluation of another paediatric extension for Moderna’s COVID-19 vaccine to children from 6 to 11.
The Board heard of the unprecedented efforts to increase the manufacturing capacity of COVID-19 vaccines to support distribution of vaccines in the EU and global exports. Over the last quarter of 2021, EMA has made significant progress in the approvals of treatments for COVID-19. Six medicines have now been authorised for use in the EU following the recommendation for a marketing authorisation by EMA. This includes two medicines (Kineret and Xevudy) that were recommended for approval by EMA’s human medicines committee, the CHMP, this week.
The Agency also gave an update on the status of its COVID-19 lessons learnt exercise: two workshops, one on resourcing and process optimisation and one on communication will be organised within the regulatory network in early 2022 by EMA together with national competent authorities.
The Board noted that EMA has continued to engage with other international regulators, for example through the International Coalition of Medicines Regulatory Authorities (ICMRA).
EMA has also enhanced its efforts to provide accurate and timely information to EU citizens and other stakeholders to support the response to the pandemic.
The Board was also updated on the actions taken following the COVID-19-related cyberattack detected in early December last year. EMA is dedicating resources, investing significantly to avoid cybersecurity issues and enhancing its information security systems to protect the Agency from future attacks.
EMA budget for 2022
The Board adopted EMA’s budget for 2022 and the programming document for 2022-2024. Both documents will be published on EMA’s website in Q1 2022. The 2022 budget increased by about 8.16% compared to the 2021 budget, to a total of 417 million euros. The budget includes 36 million euros to implement activities related to the reinforced role for the Agency in crisis preparedness and the management of medicine and medical device shortages. The Board also adopted a preliminary draft programming document for 2023-2025.
Preparation for go-live of Clinical Trials Information System and application of Clinical Trial Regulation on 31 January 2022
Delivery of the Clinical Trials Information System (CTIS) is on track for go-live on 31 January 2022, when the Clinical Trial Regulation (CTR) comes into application. The Board noted the CTR/CTIS Network communication strategy, the EU query management process and the high-level CTIS 2022 planning, which focuses on delivering a smooth go-live of CTIS, assisting sponsors and Member States with CTIS processes and strengthening and further developing CTIS.
As the CTIS go-live date approaches it is important that clinical trial sponsor organisations, authorities, ethics committees and other stakeholders involved in clinical trials prepare for the new ways of working in CTIS. An extensive training programme and supporting materials are available to assist organisations and users in preparations. Sponsors are reminded that they must use the coming year to build competence and experience in using CTIS since all new clinical trial applications must be submitted via CTIS as of 31 January 2023.
Planning for the implementation of the Commission Implementing Regulation on clinical trial safety and the development of solutions for safety reporting and Member State cooperation on safety assessment is also on track for go-live.
Data standardisations strategy
The Board endorsed a data standards strategy which sets out principles to guide the definition, adoption and implementation of data standards by the European Medicines Regulatory Network. The creation of the strategy will enable quicker uptake of data standards across the EU, improve data quality and enable data linkage and data analysis to support medicine regulation. The strategy, which was endorsed by the Heads of Medicines Agencies (HMA) in November, is an important deliverable of the Big Data Steering Group workplan and will help deliver the data pillar of the network strategy to 2025. It will be updated over time to reflect changes in priorities and additions of new requirements.
Accelerating Clinical Trials in the EU (ACT EU)
The Board endorsed the proposal to establish Accelerate Clinical Trials in the European Union (ACT EU), a joint initiative of the European Commission, Heads of Medicines Agencies and EMA. The implementation of ACT EU will support the operation of the Clinical Trials Regulation (CTR) and contribute to delivering the European Medicines Agencies Network Strategy to 2025 recommendation to support innovation and digitalisation in clinical trials. Some of the key priorities for 2022 and 2023 include supporting implementation of the CTR, modernising good clinical practice and clinical trial methods, developing a governance rationalisation strategy, establishing a multi-stakeholder platform including patients and supporting safety monitoring in clinical trials. Following the endorsement of the proposal, a revised Coordination Group will be established to steer ACT EU and an implementation plan will be presented at the next Management Board. EMA will communicate further on this topic in early 2022.
Preparation for the implementation of the Veterinary Medicinal Products Regulation
Delivery of the Union Product Database, the Union Pharmacovigilance Database and the Union Manufacturers and Wholesale Distributors Database is on track for go-live on 28 January 2022, when the new veterinary regulation for the authorisation, use and monitoring of veterinary medicinal products becomes applicable in the EU. An extensive training programme is ongoing and provisions are being made for enhanced support functions after the go live.
The Board acknowledged the preparations for the implementation of the regulation and endorsed the extension of the expiry date of the “Revised policy for classification and incentives for veterinary medicinal products indicated for minor use minor species (MUMS/limited market)” to 27 January 2022. This policy was introduced in September 2009 to stimulate development of veterinary medicines in Europe and the extension provides for coverage until the limited market provisions of the new regulation come into force.
The Board adopted the mandate of the future VMP-Reg Systems Improvement Advisory Group (VSIAG). The group will include representatives from the network, industry and veterinary healthcare professionals and will be in charge of proposing new functionalities and improvements to be prioritised for VMP-Reg related IT systems.
Finally, revised rules of procedure [LINK] for the Committee for Veterinary Medicinal Products (CVMP) were approved and will enter into force on 28 January 2022. The updated rules are required to implement the changes brought about by the new veterinary regulation and cover topics such as the delegation of tasks between Member States or scientific opinions for international organisations for animal health.
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