EU plans new Health Authority

Recommendation
29/30 April 2025
Hamburg, Germany
Batch Manufacturing Documents: from Preparation to Operational Excellence
The European Commission is planning to create a new EU Health Emergency Preparedness and Response Authority (HERA). For this purpose, the Commission has published a so-called Inception Impact Assessment and opened a feedback procedure.
As the name suggests, HERA's primary tasks are to coordinate measures to deal with health emergencies at EU level, monitor development capacities and identify potential problems. Emergency tasks are to include, for example:
- Coordinating between relevant Union agencies, national authorities and external stakeholders (e.g. industry, academic institutions, research organisations).
- Monitoring development capacities
- Promoting advanced research, innovation and development of relevant technologies and countermeasures for anticipated cross-border health threats
- Build flexible and scalable EU production capacity for the development of crisis-relevant countermeasures (including crisis-relevant raw materials)
- Competence for financing and procurement in case of need, including a logistical infrastructure (storage and distribution)
The feedback process is open until 24 February 2021, after which there will be a public consultation. Adoption by the European Commission is planned for the last quarter of 2021. For more information, please visit the website of the European Commission.
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