EU plans new Health Authority
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.
Related GMP News
02.10.2024MHRA: New Rules for Manufacturers and Wholesalers after Brexit
24.09.2024What is RCA (Root Cause Analysis)?
18.09.2024Lack of GMP Training and related Documentation: What Deviations can be found in FDA Warning Letters?
04.09.2024Switzerland: Changes for the Qualification of QPs (Responsible Person; RP in Switzerland)
04.09.2024Insufficient Root Cause Analysis leads to FDA Warning Letter
28.08.2024Switzerland to implement Measures to combat Shortages of Medicines