14/15 February 2023
A regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 "on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices").
The regulation will apply from 1 March 2022 (with the exception of the provisions on shortages of critical medical devices, which will apply from 2 February 2023). The document also assigns several new tasks to the EMA. For example, as part of its extended mandate, EMA will be entrusted with monitoring potential crisis situations. These include, for example drug shortages and shortages of critical medicines. To this end, the EMA is to establish, maintain and manage a European medicines shortage surveillance platform by early 2025.
The EMA has also been given responsibility for coordinating several EU expert panels to advise Member States and the European Commission on high-risk medical devices and in vitro diagnostic medical devices.
The aim of the Regulation is thus to ensure the smooth functioning of the internal market for medicinal products and medical devices in crisis situations. In addition, this regulation aims to improve the quality, safety and efficacy of medicinal products for emergencies.
The aim is to clarify the respective roles and obligations of the different bodies concerned. The framework established by this Regulation should build on the solutions defined and established during the COVID 19 pandemic, but also benefit from lessons learned, best practices and examples from third countries.
In order to facilitate the monitoring and reporting of actual or potential shortages of medicinal products and medical devices, the Agency should be able to request and receive information and data from affected marketing authorisation holders, manufacturers and Member States through designated single points of contact.
To this end, EMA should then set up an IT platform called the European Shortages Monitoring Platform (ESMP). The ESMP should enable national competent authorities to submit and monitor information on shortages, including information received from marketing authorisation holders, wholesalers and other natural or legal persons. The ESMP, once operational, is to act as a single portal for marketing authorisation holders to provide information required in the event of public health emergencies and major incidents.
In relation to medicines, an Executive Steering Group (Medicine Shortages Steering Group - MSSG) is to be established within the Agency to respond accordingly and coordinate actions within the Union in relation to addressing the problems of supply of medicines. The MSSG will also draw up lists of critical medicines and be able to provide appropriate advice and recommendations. Similarly, there will be a Medical Device Shortages Steering Group - MDSSG.
Furthermore, an Emergency Task Force (ETF) will be established, which will also act in an advisory capacity. The ETF will advise on scientific issues, e.g. vaccine development and clinical trials.