EMA Management Board: highlights of March 2022 meeting
Lorraine Nolan elected as new Chair of the Management Board
At its 16-17 March meeting, the European Medicines Agency’s (EMA) Management Board elected Dr Lorraine Nolan, Chief Executive of the Irish Health Products Regulatory Authority (HPRA), as chair of the Board for a three-year period. She takes over from Dr Christa Wirthumer-Hoche, whose second three-year mandate has come to an end. For further information, please see a separate news announcement.
Regulatory and coordinating actions arising from the war in Ukraine
The Board heard an update on the Agency’s regulatory and coordinating activities to prepare for potential medicine-related consequences arising from the Russian invasion in Ukraine. This includes the monitoring of possible shortages of medicines in the European Union (EU) driven by changes in demand and in supply, as well as a proactive assessment of the availability of suitable alternatives in the EU for essential medicines used in the Ukraine to make sure that refugees can continue their treatment uninterrupted, if needed.
An overview of recent COVID-19 related activities was presented. Since the last meeting of the Board, EMA’s human medicines committee (CHMP) has recommended a conditional marketing authorisation for Nuvaxovid, the fifth COVID-19 vaccine authorised in the EU for preventing COVID-19. In February 2022, the CHMP recommended extending the use of Spikevax to children aged 6 to 11. In December 2021, the Committee gave a recommendation for the use of Comirnaty as a booster in adolescents from 12 years of age. The CHMP also gave a positive opinion for the first oral antiviral. Paxlovid is authorised for adults who are at increased risk of hospitalisation and death from COVID-19.
EMA extended mandate
The Board was informed on plans for implementing the new EU regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices, which became applicable on 1 March 2022. It adopted the composition of the new Emergency Task Force (ETF), which will take over the activities of the current COVID-19 EMA pandemic Task Force (COVID-ETF). The new ETF is expected to become fully operational by mid-April, once the Management Board and European Commission have given a positive opinion on its Rules of Procedure. The ETF will provide scientific advice on medicines with the potential to address public health emergencies and will also support EMA’s committees in the evaluation and safety monitoring of such medicines. The Board also discussed the draft Rules of Procedure of the Medicines Shortages Steering Group (MSSG), which will be tasked with monitoring and mitigating shortages of medicinal products in certain crisis situations. Members were also informed on initial plans to implement the new tasks for shortages of medical devices, which will become applicable in February 2023, and on first experiences supporting the Expert Panels on medical devices, which were successfully transferred from the European Commission to EMA on 1 March 2022.
Clinical Trials Regulation
The Board welcomed the successful launch of the Clinical Trials Information System (CTIS) and the Clinical Trials website on 31 January 2022, when the Clinical Trials Regulation (CTR) and the EC Implementing Regulation (IR) on the cooperation of Member States in the safety assessment of clinical trials entered into application. Sponsors can now use CTIS to submit new clinical trial applications and to transfer trials from the Clinical Trials Directive to the Clinical Trials Regulation. As of 17 March 2022, over 5,000 logins to CTIS had been recorded and sponsors had submitted 14 clinical trial applications for assessment by the relevant regulatory authorities. To support Member States’ cooperation in the safety assessment of clinical trials, EMA, the EC and the Member States delivered new IT systems including a dedicated clinical trials safety monitoring dashboard, a document repository and a system to facilitate communication.
The Board was also informed about the current state of play of the initiative to Accelerate Clinical Trials in the EU (ACT EU). The ACT EU Steering Group has been established, with a mandate to monitor the implementation of the Clinical Trials Regulation, to enhance the EU environment for innovative, clinical research, to act as a decision-making body on further development and activities related to the CTIS, and to ensure the successful delivery of the ACT EU work programme.
Veterinary Medicinal Products Regulation
The Board also welcomed the launch of the IT systems for the Veterinary Medicinal Products Regulation on 28 January 2022, when the new legislation came into application. The Union Product Database, the Union Pharmacovigilance Database, and the Manufacturing and Wholesale Distribution Database support the simplification of many regulatory procedures. The Veterinary Medicines information website is also live and allows the public to search for information on all veterinary medicines authorised in the EU/EEA. Thanks to the effort and collaboration between national competent authorities and EMA, a high proportion of product data have now been uploaded into the Union Product Database. Since the launch of the systems, national regulators and EMA have continued to complete and enrich the information on products authorised before 28 January, which will allow marketing authorisation holders to perform regulatory procedures in the Union Product Database, such as the submission of variations not requiring assessment.
12th annual report: MUMS/limited markets scheme for veterinary medicines
The Board endorsed the twelfth and final report on the minor uses / minor species (MUMS) and limited markets scheme for veterinary medicines. The scheme is now superseded by the legal provisions to boost the development of new medicines for limited markets introduced by the new Veterinary Regulation. The report concludes that the scheme has helped to make new veterinary medicines available to treat minor animal species and uncommon diseases in major animal species.
EMA annual report 2021
The Board adopted EMA’s annual report for 2021, a year during which the Agency again focused on the response to the COVID-19 pandemic but also increased its regulatory activities overall. EMA recommended 92 medicines for marketing authorisation for human use, 54 of which contained new active substances, including a first-in-class treatment for an aggressive form of breast cancer and the first cell-based gene therapy to treat multiple myeloma. In the veterinary medicine area, EMA recommended 12 medicines for marketing authorisation, including 5 vaccines, such as a new vaccine for pigs which has the potential to reduce the need for antimicrobial treatment in animals and could limit the development of antimicrobial resistance. Publication of the 2021 report, including an interactive digital version, is planned for May 2022.
2021 EMA annual report on independence
The Board endorsed the EMA’s annual report on independence for 2021. The report is published since 2016 as an extra transparency measure on the implementation of the policies applied by the Agency to ensure the independence of scientific experts, Management Board members and EMA staff. The report provides facts and figures on controls performed in 2021 and identifies recommendations for further improvement. In addition, it describes planned initiatives for 2022, which include amendments of the existing policies on the handling of competing interests in line with the new tasks of Regulation EU 2022/123.