PROJECT NAME

Supporting the increased capacity and competence building of the EU medicines regulatory network (IncreaseNET)

SUMMARY

Regulatory assessors are increasingly challenged by an increase of workload, and a rapid evolution of scientific developments for which expertise and frameworks are not available. Additionally, the lack of work-sharing, co-working and collaboration prevents efficient use of current resources. To address this, the proposed JA of 29 partners (mostly NCAs) aims to close the identified gaps in required capacity, competences, and frameworks. Firstly, the JA aims to developing training courses in the areas of most pressing needs. To identify most pressing needs, mapping of the content of EU-NTC and of other training materials will be performed. To achieve best results, optimal methodologies for education of assessors will be developed. Secondly, the JA will establish an on-the-job training program, that will support learning and coaching activities. It will focus on newly hired assessors or assessors wishing to expand their expertise. This is the focus of the JA as it provides a framework for increasing capacities and competence needed to support regulatory procedures and to face the challenges represented by innovation. With the aim to improve the capacities this JA will also promote efficient use of resources by encouraging identification and exchange of knowledge capacity to support long-lasting collaboration between NCAs and supporting combining NCAs into MNATs. The JA will also provide recommendations on optimisation of processes in EMRN, possibilities for worksharing, co-working and avoiding duplications (MNATs to DCPs and BE work-sharing). Emphasis of the JA will be placed on helping NCAs support innovation by promoting collaboration between NCAs and Academia/SMEs. To support NCAs in addressing these its challenges, it will also collect best practices and perform an impact assessment of new technologies. Finally, to prevent duplication of work and to ensure sustainability, all activities will be carried out in collaboration with EU-NTC, EU-IN, ACT-EU, CMDh, CHMP, CAT, BWP and CTCG.

DURATION OF THE PROJECT

1.1.2024 – 31.12.2026

BUDGET

EUR 10 million
EC co-financing EUR 7,99 million (80%)

PARTNERS

27 EU/EEA members and Ukraine

Coordinator: JAZMP (Slovenia)

Partners:

AGES (Austria), FAMHP (Belgium), HALMED (Croatia), MOH CY-PHS (Cyprus), SÚKL (Czech Republic), DKMA (Denmark), SAM (Estonia), FIMEA (Finland), ANSM (France), BfArM (Germany), NNGYK (Hungary), HPRA (Ireland), AIFA (Italy), SMCA (Lithuania), MMA (Malta), CBG-MEB (Netherlands), NOMA (Norway), MUL (Poland), INFARMED (Portugal), NAMMDR (Romania), SUKL (Slovakia), AEMPS (Spain), MPA (Sweden), SECMOH (Ukraine), PEI (Germany), IMA (Iceland), SAM (Latvia), DISA (Luxembourg)

STAKEHOLDERS AND RELATED SITES

European Medicines Regulatory Network (EMRN)
European Medicines Agency (EMA)
Heads of Medicines Agencies (HMA)
European Commission (EC)
EU4Health programme 2021-2027 (EU4Health)
European Health and Digital Executive Agency (HaDEA)
EU Network Training Centre (EU NTC)
Committee for Medicinal Products for Human Use (CHMP)
Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh)
EU Innovation Network (EU-IN)
Committee for Advanced Therapies (CAT)
Biologics Working Party (BWP)
Accelerating Clinical Trials in the EU (ACT EU)

ROLE OF JAZMP 

JAZMP will act as a project coordinator, making sure that the project follows the proposed work plan as well as timelines.

COORDINATOR CONTACT

Detailed information are available on the following LEAFLET.

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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 European Health and Digital Executive Agency (HaDEA). Neither the European Union nor HaDEA can be held responsible for them.