December 15, 2023

News from the European Medicines Agency

The European Medicines Agency has held very important meetings in the past months in which IPOPI was present.

Patients’ and consumers’ working party meetings of September and November 2023.

The meetings were attended by Jose Drabwell, IPOPI Board Member, and amongst the long list of topics discussed, we would highlight the following:

– Emergency Task Force activities were explained by Jose Drabwell (as patient representative participating in the Task Force) and Anita Simonds (as healthcare representative in the Task Force). This Task Force was set up in preparation to, and during, a health emergency to provide scientific advice and to review scientific data on medicines targeting the health emergency, and to provide scientific support for the development of clinical trials for these medicines as well as recommendations to its usage.

– Big Data Steering Group is discussing how to integrate patient experience data in all aspects of medicines’ development and regulation.

– Update on preparedness activities for autumn/winter, linked to the potential shortages of key medicines such as antibiotics, paediatric analgesics, antipyretics, and cough syrups. Last year, in autumn and winter, there was a high media and social attention to the shortages in certain medicines and in order to prevent such situation, the EMA has started working ahead in collaboration with national medicines’ agencies. In any case, should patients experience any shortage, they should relay the situation to their national authority or to the EMA.

– In parallel, to prevent short term shortages in the coming months, the EMA is working on a Union list of critical medicines. The work to draft such list has already started and the experts are currently looking into published national lists of critical medicines, and a first version was released on December 12, 2023, in which immunoglobulin replacement therapies were included. This first version, planned to occur throughout 2024, is based on the national lists of 6 countries (Spain, France, Greece, Portugal, Sweden and Germany) and will be subject to modification in subsequent versions which will prioritise the review of therapeutic groups of major interest.

Interested in hearing more? The slides from the meeting in September are available here and the ones from November here.

Workshop on generating clinical evidence for treatment and prevention options for long-COVID / post-acute sequelae condition on November 17, 2023. The workshop was attended by Jose Drabwell and Samya van Coillie, IPOPI’s medical affairs project manager. The meeting aimed at understanding the mechanisms and the clinical syndromes associated with long-COVID / post-acute sequelae condition. The workshop also discussed the regulatory and methodological concerns related to the clinical trials for therapies and vaccines against COVID-19.