The Joint Action EU4H11 included in the EU4Health Programme and funded by the European Commission 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. The Joint Action is steered by AGES/BASG (Austrian Agency for Health and Food Safety / Austrian Federal Office for Safety in Health Care) as Coordinator, together with the National Competent Authorities (NCAs) of France (ANSM), Croatia (HALMED) and Hungary (NCPHP) as work package leaders.
In total, 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 total budget of this Joint Action amounts to more than three Million Euros, 80 percent of the costs will be co-financed by the European Commission. The Health and Digital Executive Agency (HaDEA) as Granting Authority is managing this Joint Action EU4H11 as part of implementing the EU4Health Programme.
Project description and benefits
The project participants are the national competent authorities (NCAs) – medicines inspectorates in EU/EEA region: they are supervising the regulatory compliance (GMP - Good Manufacturing Practice) of pharmaceutical manufacturers of human and veterinary medicines throughout EU/EEA. Good manufacturing practice (GMP) refers to the guidelines for quality assurance in production processes to ensure safe and high-quality medicinal products.
The three main goals of EU4H11 are:
- Strengthening the Joint Audit Programme (JAP) for EU/EEA GMP Inspectorates: Heads of Medicines Agencies have agreed on setting up the JAP to verify the implementation and equivalence of EU/EEA GMP inspectorates with relevant provisions of European Directives into national laws, and in coherence with the Compilation of Union Procedures on Inspections. It aims to maintain mutual confidence in the EU/EEA GMP inspection systems, and consequently in the EU/EEA Inspections Network. Additionally, the JAP serves as a basis for Mutual Recognition Agreements (MRA) with Third-Countries. This Joint Action EU4H11 will work on optimising training and qualification processes for auditors as well as the JAP procedures for GMP inspections. Furthermore, the co-financing of costs related to JAP activities supports member states’ participation in the Joint Audit Programme.
- 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.
- Enhancing EU/EEA GMP inspectors’ competences by establishing harmonised training and qualification processes for GMP inspectors, in cooperation with the PIC/S Inspectorates’ Academy. Furthermore, the co-financing of costs related to training activities supports member states’ participation.
Virtual JAP/JRP auditor training October 5th/6th 2023
The 2023 Virtual JAP/JRP Auditor Training was organised by ANSM (FR) on October 5th to 6th 2023 within the frame of the EU Joint Action EU4H11. It 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. The training course was primarily targeted to auditors operating in the frameworks of the EU/EEA Joint Audit Programme (JAP) and/or the PIC/S Joint Reassessment Programme (JRP). The training was attended by more than 150 participants from 50 national competent authorities.
The training course was opened and chaired by Olivier Gross (EC/DG SANTE). Firstly, participants were introduced to basic concepts comprising goals, overview, roles, and responsibilities of the JAP/JRP programmes by Giampiero Lorenti, AIFA (IT), Chair of the Compliance Group of EMA’s GMDP Inspectors’ Working Group and Jacques Morénas, ANSM (FR), Chair of the PIC/S Sub-Committee on Training for PIC/S. The second part offered detail guidance and insights in audit planning, preparation, conduct, reporting and follow-up – as well as the specific part of observing an inspection.
The speakers, long-experienced auditors and/or persons with long experience in the field of GMP regulatory compliance programmes, shared their knowledge, best practices and facilitated discussions on the specific topics. In a third section, the 78 indicators of the audit checklist were explained in detail, to be rounded up by a presentation on audit techniques (soft skills). All along the sessions, GMP inspectors / staff of GMP inspectorates could build up knowledge and discuss with experienced auditors in various Q&A sessions to contribute regularly as an auditor in the future – and/or to strengthen the understanding of the JAP/JRP indicators as auditee. Finally, participants received detailed information about co-financing options of different JAP auditor trainings through EU4H11, directed to those EU/EEA authorities participating in EU4H11 Joint Action.
The recording of the virtual training course will be available for access to EU/EEA Authorities via EU NTC and for PIC/S Participating Authorities via PIA in the coming weeks.
EU4H11 update 11/2023: 12 months project progress
The Joint Action EU4H11 is ongoing since November 1st 2022. The Kick-off meeting for EU4H 11 was successfully organised as a hybrid meeting at AGES/BASG (AT), Vienna from December 5th to 6th 2022. During the first few months, the project plans were refined, and processes were defined. Those are continuously implemented in the four mandatory work packages. Co-financing of JAP activities and GMP inspectors’ training activities is ongoing. The activities in work packages 5 and 6 have been launched at the beginning of 2023. Work package 7 activities will start in 2024 as planned. ANSM (FR) is leading work package 5. It aims at strengthening the Joint Audit Programme (JAP) for EU/EEA GMP Inspectorates by optimising training and qualification processes for auditors as well as existing JAP processes. NCPHP (HU) is leading work package 6. It works towards harmonization of GDP inspection standards. A proposal to include GDP to the existing Joint Audit Programme will be developed.
Addition of Project Partners
The addition of seven EU/EEA Medicines Inspectorates for veterinary medicines has been completed. A total number of 39 participating partner agencies has been reached.
Recent proposals on EU-level
The Joint Audit Programme (JAP) is part of the recently published draft of the new Pharma Legislation, proposed by the European Commission to become mandatory by the respective Regulation (Article 54). According to the proposal, each Member State shall provide trained auditors. In addition, a new Procedure “EU/EEA Programme for Maintenance of Equivalence in Supervision of Good Manufacturing Practice (GMP) Compliance of Pharmaceutical Companies” has been added to the Compilation of Union Procedures on Inspections and Exchange of Information in June 2023 (Rev. 19). This new procedure details elements to achieve and maintain equivalent supervision standards throughout EU/EEA. Amongst others, the active contribution to the Joint Audit Programme by EU/EEA competent authorities through provision of auditors is expected.
- The qualification process for JAP auditors has been finalised.
- The first Joint Action (online) training session for JAP/JRP auditors was held from 5-6 Oct 2023. The training was organised by ANSM with additional support from the European Commission, EMA and Pharmaceutical Inspection Cooperation Scheme (PIC/S). The participation of senior auditors from European or PIC/S authorities as trainers allowed future auditors to benefit from their valuable experience. The training was attended by 150 participants. GMP inspectors / staff of GMP inspectorates have been trained in detail to contribute as an auditor in the future – and/or to strengthen the understanding of the JAP/JRP programmes / indicators as auditee. The recording of the virtual training course will be available for access to EU/EEA Authorities via EU NTC and for PIC/S Participating Authorities via PIC/S Inspectorate’s Academy (PIA).
Joint Actions in the framework of the EU4Health programme provide co-financing by the European Union in form of a direct grant to member states. National Competent Authorities must be nominated by the respective EU4Health Nominating Authority. In Austria the Federal Ministry of Social Affairs, Health, Care and Consumer Protection (BMSGPK) is the responsible body hereof. EU4H11 relates to the action area of implementation of pharmaceutical legislation and pharmaceutical strategy to strengthen health systems. The Federal Ministry has nominated AGES to participate in EU4H11 on behalf of Austria and provides additional financial support.
Project name: Joint Action on quality of medicines and implementation of the pharmaceutical legislation/strategy
Project acronym: EU4H11
Project management: Austrian Agency for Health an Food Safety (AGES, Medical Market Surveillance) / Austrian Federal Office for Safety in Healthcare (BASG), Mag. Andreas Kraßnigg
Project partners: 39 medicinal product inspectorates from a total of 29 EU/EEA Member States
- Austria: AUSTRIAN AGENCY FOR HEALTH AND FOOD SAFETY GMBH (AGES)
- Belgium: FEDERAL AGENCY FOR MEDICINES AND HEALTH PRODUCTS (FAMHP)
- Bulgaria: BULGARIAN DRUG AGENCY (BDA)
- Bulgaria: BULGARIAN FOOD SAFETY AGENCY (BFSA)
- Croatia: AGENCIJA ZA LIJEKOVE I MEDICINSKE PROIZVODE (HALMED)
- Cyprus: PHARMACEUTICAL SERVICES, MINISTRY OF HEALTH (PHS MOH)
- Cyprus: MINISTRY OF AGRICULTURE, RURAL DEVELOPMENT AND ENVIRONMENT OF CYPRUS (MoA-Vet Services)
- Czechia: STATNI USTAV PRO KONTROLU LECIV (SÚKL)
- Czechia: USTAV PRO STATNI KONTROLU VETERINARNICH BIOPREPARATU A LECIV (USKVBL)
- Denmark: LAEGEMIDDELSTYRELSEN (DKMA)
- Estonia: RAVIMIAMET
- Finland: LAAKEALAN TURVALLISUUS-JA KEHITTAMISKESKUS (FIMEA)
- France: AGENCE NATIONALE DE SECURITE DU MEDICAMENT ET DES PRODUITS DE SANTE (ANSM)
- France: AGENCE NATIONALE DE LA SECURITE SANITAIRE DE L'ALIMENTATION, DE L'ENVIRONNEMENT ET DU TRAVAIL (ANSES)
- Germany: NATIONAL CENTRE FOR HEALTH PROTECTION OF MEDICINAL PRODUCTS AND MEDICAL DEVICES (ZLG)
- Greece: ETHNIKOS ORGANISMOS FARMAKON (EOF)
- Hungary: ORSZAGOS GYOGYSZERESZETI ES ELELMEZES-EGESZSEGUGYI INTEZET (OGYÉI/NIPN)
- Hungary: NEMZETI ELELMISZERLANC-BIZTONSAGI HIVATAL (NÉBIH)
- Iceland: ICELANDIC MEDICINES AGENCY (LYFJASTOFNUN)
- Ireland: HEALTH PRODUCTS REGULATORY AUTHORITY (HPRA)
- Italy: AGENZIA ITALIANA DEL FARMACO (AIFA)
- Italy: MINISTERO DELLA SALUTE (MoH-DGSAF-IT)
- Latvia: ZALU VALSTS AGENTURA (ZVA)
- Latvia: PARTIKAS UN VETERINARAIS DIENESTS (FVS)
- Lithuania: VALSTYBINE VAISTU KONTROLES TARNYBAPRIE LIETUVOS RESPUBLIKOS SVEIKATOS APSAUGOS MINISTERIJOS (VVKT)
- Lithuania: VALSTYBINĖ MAISTO IR VETERINARIJOS TARNYBA / State Food and Veterinary Service (VMVT)
- Luxembourg: MINISTERE DE LA SANTE (MOHLUX)
- Malta: THE MEDICINES AUTHORITY (MALTA MA)
- Malta: MINISTRY FOR AGRICULTURE, FISHERIES AND ANIMAL RIGHTS Animal Health and Welfare Department (MAFA-AHWD)
- Netherlands: MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT (IGJ-NL)
- Norway: THE NORWEGIAN MEDICINES AGENCY (NOMA)
- Poland: GLOWNY INSPEKTORAT FARMACEUTYCZNY (CPI)
- Portugal: INFARMED - AUTORIDADE NACIONAL DO MEDICAMENTO E PRODUTOS DA SAUDE IP (INFARMED)
- Portugal: DIRECCAO-GERAL DE ALIMENTACAO E VETERINARIA (DGAV)
- Romania: AGENTIA NATIONALA A MEDICAMENTULUI SI A DISPOZITIVELOR MEDICALE DIN ROMANIA - NATIONAL AGENCY FOR MEDICINES AND MEDICAL DEVICES OF ROMANIA (ANMDMR)
- Slovakia: STATNY USTAV PRE KONTROLU LIECIV (SÚKL SK)
- Slovenia: JAVNA AGENCIJA REPUBLIKE SLOVENIJE ZA ZDRAVILA IN MEDICINSKE PRIPOMOCKE (JAZMP)
- Spain: AGENCIA ESPANOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS (AEMPS)
- Sweden: LAKEMEDELSVERKET (MPA)
Funding: The Joint Action EU4H11 is co-financed by the European Union. Grant Agreement 101082515- EU4H-2021-JA2-IBA
Project duration: 01.11.2022 until 31.12.2025
Last updated: 22.01.2024