EMA Management Board: highlights of October 2022 meeting

News 07/10/2022

At its 6 October 2022 meeting in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to the response to COVID-19, focusing on the recent reviews of the adapted mRNA vaccines. A total of six vaccines, three adapted booster vaccines and eight treatments have been authorised for use in the European Union (EU) since the start of the pandemic.

Mid-year report 2022

EMA presented the report of activities for the first half of 2022. For human medicines, the total scientific advice and protocol assistance requests confirmed a five-year trend for growth with 470 requests received (454 in 2021). The initial evaluation of COVID-19 related products decreased; five applications received in the first half of 2022 vs 14 in 2021. For the veterinary medicine activities, the total figure for initial evaluation doubled (four in the first half of 2021 vs nine in the first six months of 2022). In addition, the Agency revised and finalised 12 guidelines and procedural advice for the application of the new veterinary legislation.

The 2022 mid-year report will be published on the EMA website shortly.

EMA extended mandate

The Board heard an update about the implementation of the EU regulation that reinforces EMA’s role in crisis preparedness and management for medicinal products and medical devices. In addition to the activities on COVID-19, EMA initiated a series of actions to respond to the ongoing monkeypox outbreak, the first public health emergency that has been declared since the regulation became applicable on March 2022. This includes the creation of a list of critical medicines produced and maintained by the Medicines Shortages Steering Group (MSSG). Also, the mandate of the Emergency Task Force (ETF), has been formally extended to cover monkeypox, in addition to its activities in relation to COVID-19.

The Board received an update on the activities carried out by the expert panels on medical devices from the 1st of March 2022, when EMA took over responsibility for the secretariat of these panels as part of its extended mandate.

Revision of independence policies

The Board was informed about the proposed revision of EMA’s independence policies for competing interests of Scientific Committee members, Experts and Management Board members. This review follows the entry into application of the recent changes to EMA’s mandate and the new Medical Device and in vitro Medical Device Regulations, which increase EMA’s role in the MD/IVD area. The general principles for the revision of the policies were endorsed and the revised independence policies will be submitted for Management Board approval via written procedure later this year. Once adopted they will be published on EMA’s website.

Revision of rules of procedure for EMA committees

The Board gave a favourable opinion to revise of the rules of procedure of two scientific committees of EMA: the Committee for Advanced Therapies (CAT) and the Committee for Medicinal Products for Human Use (CHMP).

Following the entry into force of the regulations on Medical Devices and In-Vitro Diagnostic Devices, changes to the rules of procedure of the CAT and the CHMP are required to make the legislative provisions related to the work of EMA in the area of medical devices fully reflected in their mandates. In addition, the CHMP’s rules of procedure now also outline the interaction with the Emergency Task Force (ETF). The revised rules of procedure will apply as of 20 October 2022.

Review of activities of EMA Working Parties

An update on the implementation plan of the new operational model of the working parties of EMA was presented to the Board. The first phase of the project concluded in September 2022 and focused on the reorganisation of the working parties for the non-clinical, methodology and clinical domains. In addition, the pilot phase of the European Specialised Expert Community (ESEC) started in the second quarter of 2022. In preparation for the second phase of the implementation plan, the methodology and timelines of the quality domain were discussed considering the fundamental dependencies with the core business.

Operation of CTIS and implementation of the Clinical Trials Regulation

The Board heard an update on the implementation of the Clinical Trials Regulation (CTR) and the recent actions to improve the user experience of the Clinical Trials Information System (CTIS). While most clinical trials submitted via CTIS have been approved successfully, the Management Board noted that a number of technical issues have resulted in a small number of users requiring intensive support.

Member States were reminded of the need to work with stakeholders to prepare for the mandatory use of CTIS as of 31 January 2023 and to use all available resources to this effect. The Board noted that EMA is investing additional contractor and staff resources. The Board welcomed EMA’s commitment to intensively collaborate with sponsors and Member States to ensure an improved CTIS user experience for core CTIS processes by the time of compulsory use of the system for all new applications.

Update on the implementation of Veterinary Medicinal Products Regulation

The Board noted the continued efforts and collaboration between national competent authorities and EMA to finalise the upload of product data into the Union Product Database. Since the launch of the IT systems for the Veterinary Medicinal Products Regulation in January 2022, EMA has continued to provide releases offering new and improved functionalities. The Board welcomed the commitment that this work will continue in 2023 after the transition of the programme into the Agency’s agile governance model by the end of 2022.

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