EU4H11 project
The Chief Pharmaceutical Inspectorate is the beneficiary of the EU4H11 project “Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy”.
Basic project data:
Call: EU4H11-2021-JA-11 (101082515)
Type of Action: EU4H 11
Duration: 36 months
Start Date: 01 Nov 2022
Estimated Project Cost: €3,424,698.71
Requested EU Contribution: €2,739,758.97
Contact to Coordinator: AGES - Austrian Agency for Health and Food Safety eu4h11@ages.at
The Joint Action EU4H 11 included in the EU4Health Programme funded by the European Commission aims at strengthening capacities of EU/EEA GMP/GDP inspectorates.
The Joint Action is steered by AGES/BASG as Coordinator, together with the National Competent Authorities of France (ANSM), Croatia (HALMED) and Hungary (OGYÉI/NIPN) as work package leaders. In total, 39 EU/EEA Medicines Agencies are participating whereas further EU/EEA GMP Inspectorates may be included within the duration of the Action.
The three main goals of EU4H 11 are:
1. Strengthening the Joint Audit Programme (JAP) for EU/EEA GMP Inspectorates: The Joint Audit Programme (JAP) for Good Manufacturing Practices (GMP) inspectorates was established by the HMAs of the EU/EEA member states. It is an important tool for continuous improvement, ensures consistency of GMP standards and a harmonised approach within EU/EEA in line with the Compilation of Union Procedures on Inspections and supports confidence building within the EU/EEA and with other authorities. In addition, the Joint Audit Program serves as a fundamental basis for mutual recognition agreements with 3rd countries, such as the United States, Canada and probably the UK as well as to show equivalency with the PIC/S Joint (Re)Assessment Programme. The Joint Action EU4H11 shall support the active participation of EU/EEA inspectorates by co-financing of JAP related costs to further strengthen the EU medicines regulatory network and to ensure the harmonised oversight of the quality of medicinal products. By the means of EU4H11, training and qualification of JAP auditors as well as the processes related to the JAP shall be optimized.
2. Reviewing the national implementation of the European GDP legislation / guidelines and developing a proposal to include GDP to the existing Joint Audit Programme. By promoting collaboration between EU/EEA GDP Inspectorates, the Joint Action will strengthen the EU/EEA GDP inspectorates’ network and work towards a harmonization of GDP inspections standards.
3. Increasing EU/EEA inspectors’ capacities and qualification of inspectors by developing a process to enhance cooperation with the PIC/S Inspectorates’ Academy. Furthermore, the co-financing of costs related to training activities shall facilitate their participation.
