A reinforced role for the European Medicines Agency (EMA)
On October 28, 2021, the European Parliament and Council reached a provisional agreement to ensure the European Medicines Agency (EMA) will be more effective in monitoring and mitigating shortages of medicines and medical devices.
As announced in the EU Parliament’s press release, the EU regulators agreed to introduce a new set of tools to improve the EU health security coordination before and during crises by reinforcing the management of disruptions due to the scarcity of medicinal products.
Shortages steering groups
Thanks to the Agreement, the EMA will now see the creation of two ‘shortages steering groups’, [IMMOMD1] [LMORD2] which will meet both on a regular basis and in case of public health emergencies, to facilitate the development and faster approval of medicines and medical devices.
It is important to point out that, although the steering groups will be open to hearing expert advice from representatives of any relevant healthcare stakeholder, these must be impartial and free from interestsin related industry sectors.
Summaries of the proceedings and recommendations will also be made publicly available, to ensure the transparency of the meetings.
New key tools, more transparency for clinical trials and marketing authorizations
Among the resources that the EMA will set up to collect information on shortages, supply, and demand of medicinal products, there will also be a European Shortages Monitoring Platform and a new public webpage with information on shortages of critical medicines and medical devices.
Moreover, in case of public health emergencies, sponsors of clinical trials conducted in the EU will be demanded, at the start of the trial, to make the study protocol publicly available in the EU clinical trials register, and to publish a summary of the final results.
Whenever a medicinal product obtains marketing authorization, the EMA will also ensure to publish its information, together with the conditions of use and clinical data received (with anonymized personal data and no commercially confidential information).
The deal stems from the lessons learned from COVID-19 and contributes to the building of a stronger European Health Union, as announced by President of the European Commission Ursula von der Leyen during the World Health Summit of October 2020.
The European Parliament and Council will now have to formally endorse the content of the provisional agreement before it can enter into force (European Parliament, 2021).
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Regulatory Affairs Department Consultant
European Parliament. (2021). Deal on stronger role for EU medicines regulator. , Retrieved on 09/11/2021 from https://www.europarl.europa.eu/news/en/press-room/20211019IPR15235/deal-on-stronger-role-for-eu-medicines-regulator