INFARMED begins discussions on the strengthening of EMA’s mandate

INFARMED begins discussions on the strengthening of EMA’s mandate
March 05, 2021

INFARMED presided over another meeting of the Medicines and Medical Devices Working Group. The reunion started de debate over the regulatory proposal of the European Parliament and Council regarding the reinforcement of the role of the European Medicines Agency (EMA) in terms of readiness and crisis management concerning Medicines and Medical Devices.

After a presentation by the European Commission, the Member-States started the examination of the proposal, debating matters such as monitoring and mitigating the shortage of critical medicines and medical devices and management of major events. The proposal brings forward three main goals for the revision of EMA mandate. The first is to monitor and mitigate the shortage of medicines and medical devices considered critical for a quick reaction in a public health emergency. Or, in the case of medicines, other major events that could result in a serious risk for public health.

The second goal is the swift development of high quality, safe and effective medicines, necessary for a specific public health emergency.

The third is to ensure the proper functioning of expert panels, essential for the assessment of high-risk medical devices and also counselling in matters such readiness and crisis management

The revision of EMA’s Mandate also aims to implement the development of common tools and methods for the monitoring, communication and data collection, namely data regarding medicines and medical devices considered most likely to be impacted during a health emergency or other major event.

The proposal is part of the Health Union package and is one of the areas in which the Portuguese Presidency aims to engage, in order to push forward the implementation of the European Health Union.

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