IPOPI’s involvement at the European Medicines Agency
IPOPI is closely following and contributing to the work of the European Medicines Agency in many different areas. We are pleased to share key activities that have taken place in the past three months:
Jose Drabwell, IPOPI Board Member, provided a presentation on being a delegate on the ETF (Emergency Task Force), an advisory and support body that handles regulatory activities in preparation for, and during, a public-health emergency, such as a pandemic. Jose Drabwell was chosen as one of the two patient representatives contributing to the work of this advisory body and she reported back on her activities to the Patients and Consumers Working Party (PCWP) during a meeting held on September 19-20, 2023.
The Patients and Consumers Working Party met with the Working Party of Healthcare Professionals on September 19-20, to discuss many items of relevance to the PID community:
The development of a European list of critical medicines, based on the therapeutic importance and on the availability of alternative medicines. The methodology allows Member States to list medicines in 3 categories: 1. “critical medicine”, 2. “at-risk medicine”, or 3. “other medicine”. A first phase started on August 1, 2023, in which national regulatory authorities, in collaboration with ministries of health, are currently categorising medicines until October. The first version of the list will be available by the end of 2023.
The EMA is also working on preparedness activities, following the COVID-19 pandemic. In that sense, this is a close monitoring of events and preparedness for public health emergencies and/or major events that are currently being worked on.
Clinical trials – In July, a Clinical Trials Information System (CTIS) workshop was organised on transitional ongoing trials to the Clinical Trials Regulation. This involved mainly pharmaceutical companies and the difficulties moving information from the old system to the new Clinical Trial Registry, which was set up to facilitate reporting of clinical trials happening in several EU Member States.
the European Network of Paediatric Research (Enpr-EMA) at the EMA, met in June 2023. Enpr-EMA’s main objective is to facilitate studies to increase the availability of authorised medicines for children. One of the current tasks of the network is to develop common educational tools for children and parents, encouraging their participation in clinical trials.