Anses participates in EU4Health Joint Action EU4H11
EU4H11 (Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy) is part of the EU4Health programme funded by the European Commission. The total budget of this Joint Action amounts to more than 3 million EUR, 80% of the costs will be co-financed by the European Commission. The project aims at strengthening capacities of EU/EEA GMP/GDP inspectorates in the global vision of mutual reliance of inspection data to better ensure quality of medicinal products and protection of Public Health.
39 EU/EEA Medicines Inspectorates from a total of 29 EU/EEA countries are participating in EU4H11: they are supervising the regulatory compliance of pharmaceutical manufacturers of human and veterinary medicines throughout EU/EEA. The Joint Action is steered by Austria (AGES/BASG) as Coordinator, together with the National Competent Authorities of France (ANSM), Croatia (HALMED) and Hungary (NCPHP) as work package leaders.
The three main goals of EU4H 11 are:
- Strengthening the Joint Audit Programme (JAP) for EU/EEA GMP Inspectorates;
- Developing a proposal to include GDP to the existing Joint Audit Programme;
- Establishing harmonised training and qualification processes for GMP inspectors, in cooperation with the PIC/S Inspectorates’ Academy.
In addition, the co-financing of costs related to JAP activities supports member states’ participation in the JAP. The co-financing of costs related to training activities supports initial and continuous training of GMP inspectors, thus enhancing competences of GMP inspectors throughout EU/EEA.
For further information:
- Anses : insp@anses.fr
- EU4H11 – Coordinator AGES/BASG : eu4h11@ages.at
- Website: https://www.ages.at/en/research/project-highlights/eu4h11