On 3 March, the European Medicines Agency (EMA) convened a meeting of its Patient and Consumer’s (PCWP) and Healthcare Professionals Working Parties (HCPWP). The meeting was attended by all eligible patient organisations and professional bodies, and was chaired by Juan Garcia Burgos (EMA), Marko Korenjak (HCPWP) and Rosa Giuliani (HCPWP). The first session was focused on the reorganisation of the EMA Working Parties into a framework that is structured around different domains: quality, non-clinical, methodology, and clinical. For example, the Central Nervous Systems Working Party, which provides specialised neurology and psychiatry input, will fall under the clinical domain.
Michel Antunes of EMA also provided an overview of the new Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), which came into force in 2021 and 2022, respectively. These regulations govern the production, marketing, and sales of medical and in vitro diagnostic devices, such as syringe drivers and X-ray machines and tests to monitor blood glucose levels. Next, Maria Filancia (EMA) spoke about the ACT-EU initiative (Accelerating Clinical Trials in the EU), which aims to develop the EU as a competitive centre for innovative clinical research. She highlighted the ACT-EU multistakeholder platform, which will be a collaborative platform for stakeholder input on clinical trial innovations.
Steffen Thirstrup and Rosa Gozalez-Quevedo then provided a report on a recent EMA workshop on medicines shortages, focusing on the use of biosimilars and interchangeability between medicines. In the last presentation of the meeting, Monika Benstetter (EMA) spoke about the EMA policy on multilingualism, in which they aim to provide equal treatment to all EU languages other than English. For example, they publish information on medicines in all EU languages, and will respond to enquiries received in any EU language, in that language. On the other hand, technical information is only provided in English, as this is viewed as the global language for international exchange used by pharmaceutical companies.
Closing the meeting, Juan Garcia-Burgos thanked all speakers and participants for their contributions, announcing that the next PCWP and HCPWP meetings will be held in June. The presentations are available on the EMA website:
