The Malta Medicines Authority participates in EU4Health Joint Action EU4H 11

Published: 28 Feb 2024


The Malta Medicines Authority participates in EU4Health Joint Action EU4H 11


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 Joint Audit Program (JAP) at EU level. 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, please contact:

Malta Medicines Authority, Level 3, Sir Temi Zammit Building, Malta Life Sciences Park, San Gwann, SGN 3000, Malta; email:

EU4H11 - Coordinator AGES/BASG - email:



Disclaimer: Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.