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.

Project highlights

• 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).
   

The French Medicines Agency ANSM held the second training for auditors of the Joint Audit Programme from 3 to 4 October 2024 as part of the Joint Action. The training took place at the ANSM premises in Paris with the following objectives

• Deepening the knowledge and skills acquired during the initial theoretical training and applying them in practical workshops; and
• to immerse the participants in the real audit situation by simulating an ANSM audit.

The training event was attended by 32 participants from 18 Member States (Austria, Belgium, Bulgaria, Croatia, Cyprus, Estonia, Finland, France, Germany, Italy, Latvia, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden). An observer from the European Commission was also present. Four experienced examiners acted as trainers: Anne Hayes (IE-HPRA), Ana Rita Martins (PT-INFARMED), Andreas Kraßnigg (AT-AGES) and Jacques Morénas (FR-ANSM).

This training course, which was aimed at (future) examiners of the joint examination programme, was exceptional as it simulated an ANSM audit. Colleagues could not only practise their (future) role, but also apply their professional and social skills. In addition, this course concept allowed for a variety of discussions by sharing experiences with assessments and audit situations.

Not only did all participants gain a deeper insight, but potential for improvement in relation to the Joint Audit Programme itself also emerged. This great success was preceded by months of intensive preparatory work carried out by a large ANSM team to develop the training programme. In addition to the detailed development of the course concept by a number of colleagues involved in the delivery of the training, the relevant ANSM self-assessment and documentation for the simulated audit was also prepared and provided.

In our role as coordinator of Joint Action EU4H11 and on behalf of the entire EU/EEA inspector network, we would like to express our sincere thanks to ANSM for organising this excellent training event and to the trainers for their continuous contribution to the training. Furthermore, we are delighted to welcome our colleagues to the pool of JAP auditors!

This training course and the total of three trainings organised by ANSM in the framework of Joint Action EU4H11 will allow us to achieve one of the objectives of our project: a significant number of available, qualified auditors to sustain the Joint Audit Programme in the long term.

Since November 2023, the EU4H11 Joint Action Team is continuously making progress in implementing the action tasks aiming at strengthening the capacity of the GMDP inspectors’ network to enhance equivalency in inspections and GMDP regulatory compliance programmes. 

Summary of achievements 

1. Work Package 4 & 5 – Strengthening the Joint Audit Programme by co-funding of JAP activities, optimising training and qualification processes of JAP auditors and optimising existing JAP processes 

• The activities of the Joint Audit Programme (JAP) are continuously co-funded: Co-funding is not only provided for travel, accommodation and subsistence costs of auditors travelling to on-site audits and face-to-face trainings. Moreover, NCAs providing auditors and sponsors to run the JAP and dedicating resources for initial and continuous training of auditors receive financial support for the respective personnel costs.
• The qualification process for new JAP auditors was applied by EMA in 2024 for assignments of 2025 audits in a pilot phase, as agreed by the Compliance Group.
• Rules on reimbursement of JAP auditors’ cost detailing provisions regarding the reimbursement of JAP auditors’ expenses, were finalised and adopted by the Compliance Group, with implementation starting JAP audits in September 2024. The major change is the application of daily allowance rates established on EC level.
• A JAP audit report review checklist was developed to harmonise the JAP audit report review amongst Compliance Group sponsors. The Compliance Group agreed in September 2024 to use the checklist for a 1-year-pilot phase.
•  An advanced training course for JAP auditors was organised by ANSM at its facilities in Paris from 3rd - 4th October 2024 (refer to dedicated section). 

2. Work Package 4 & 7 –Strengthening the capacity of EU/EEA GMP inspectors by co-funding of GMP training activities and optimising training and qualification processes of GMP inspectors 

• Training activities of GMP inspectors are continuously co-funded. NCAs select trainings depending on their needs, ranging from basic to continuous training, from F2F events or online courses organised by different regulatory entities, associations and training providers to joint inspections for training purposes (Joint Inspections Training, see below). 
• The Joint Action EU4H11 supported the launch of the JIT – Joint Inspection Training of EMA in 2023. The training program aims to coordinate offers and demands for observing GMP inspections for training purposes in another EU/EEA member state. Co-funding is offered both for trainers and trainees.
• In March 2024, EU/EEA GMP inspectors and EU/EEA Heads of GMP inspectorates have been invited to complete questionnaires on training and qualification of GMP inspectors, training needs and sustainability of GMP inspectorates. 35 Heads of EU/EEA GMP Inspectorates (response rate: 83%) and a total of 148 EU/EEA GMP inspectors replied to the questionnaires. The results have been shared amongst the network and are used to define and implement recommendations. Furthermore, they will be considered for further training organisation and sustainability actions.

3. Work Package 6 – Strengthening the EU/EEA GDP inspectors’ network by harmonising GDP inspections standards

• A questionnaire on guidelines on GDP of medicinal products for human use and wholesaling activities was drawn up to perform a review of the implementation of the EU GDP legislation and notably the GDP guidelines in national GDP legislation. The questionnaire was distributed to EU/EEA NCAs and responses of 29 member states were received. The analysis of the answers is ongoing.  
• The proposal to extend the Joint Audit Programme to GDP, which was worked on since spring 2023, was finalised. It comprises a JAP GDP indicators list/audit checklist, the respective interpretation guide as well as related procedures and templates. The elaborated draft will be the basis for further discussion by the Compliance Group and finally by the entire competent EU/EEA GDP inspectorates. 

Besides the work of the technical work packages, it is highlighted that the tasks of the mandatory work packages in the established frameworks (project management/coordination, dissemination, evaluation and sustainability) are continuously implemented.

• A total of 20 joint audits with on-site date in the period from 01/11/2022 to 31/10/2024 have been co-financed. 
• By end of October 2024, 25 NCAs out of the total 42 EU-EEA NCAs (60 %) provided auditors to maintain the Joint Audit Programme (JAP).
• 32 participants from 18 EU-EEA Member States/NCAs attended the advanced training course for JAP auditors from 3rd to 4th October 2024. 
• During Joint Action runtime (1/11/2024 – 31/10/2025), we welcome additional 33 co-auditors and 14 lead auditors to run the JAP. 13 auditors-in-training join audit teams before acting as an auditor. 
• By end of April 2024, a total of 74 trainings attended by 57 EU-EEA GMP inspectors have been co-financed.
• By end of October 2024, 7 joint inspections for training purposes were performed: 7 NCAs acted as hosting NCA/trainer and 4 NCAs participated as trainee in the EU/EEA cross-border JIT - Joint Inspections Training Programme.