The FAMHP actively participates in a number of programmes and funds financed by the European Union.
1. Ongoing projects
- The UNICOM project
UNICOM is a project that sets out to ensure improved patient safety and better healthcare. The project focuses on the implementation of the International Organization for Standardization (ISO) standards for the identification of medicinal products for human use (IDMP).
The work involves the further development, testing, implementation and dissemination of those standards for:
- regulatory purposes within national medicinal products authorities and the European Medicines Agency (EMA);
- global pharmacovigilance;
- the promotion of cross-border digital health services, especially electronic prescriptions (ePrescription);
- better healthcare for all, public health services, clinical research, big data analytics, artificial intelligence applications.
Nineteen countries are represented within this project by 26 national medicinal products authorities and health institutions. The stakeholders are represented through their associations.
Participants: AEMPS (ES), FAMHP (BE), AGES (AT), ARIA (IT), BfArM (DE), BIDMC (IL), CBG (NL), COCIR (BE), CTAHDL (US), Datawizard (IT), EESAM (EE), EHTEL (BE), ELGA (AT), EMPIRICA (DE), FIMEA (FI), FOUND (IT), GNOMON (EL), HALMED (HR), HPRA (IE), HZZO (HR), IDIKA (EL), IDMP1 (DE), IEDOH (IE), IHD (BE), IHE (BE), ILIM (PL), INDRA (ES), INFARMED (PT), KELA (FI), MHRA (UK), NICTIZ (NL), NOMA (NO), REGLOMB (IT), SAS (ES), SEMPA (SE), SNOMED (UK), SPMS (IT), TEHIK (EE), VIDAL (FR), Z-INDEX (NL)
- Project CT Cure
The CT Cure project is a collaboration between 15 Member States for a harmonised and accelerated assessment of multi-national clinical trials with COVID-19 therapeutics.
Participants: SÚKL (CZ), BfArM (DE), EOF (EL), AEMPS (ES), MINISTERE DES AFFAIRES SOCIALES ET DE LA SANTE (FR), MIZ (HR), OGYEI (HU), VVKT (LT), ZVA (LV), NLNA (NL), INFARMED (PT), ANM (RO), MPA (SE), JAZMP (SI)
The FAMHP is taking on responsibility for the overall coordination of the CT Cure project and is also coordinating Work Package 6 (Expedited Assessment) to ensure that a procedure for identifying trials and expedited assessment timelines is developed.
- SAFE CT
SAFE CT (safety assessment cooperation and facilitated conduct of clinical trials) is a collaboration between the authorities of 22 countries within the European Union and the European Economic Area.
European clinical trial legislation entered into force in 2022. It stipulates how national medicinal products authorities must conduct a common evaluation for an investigational medicinal product, rather than using national procedures as before. To introduce this new approach, a training and mentoring programme is being developed and sustainable procedures will be elaborated for the future.
Participants: FAMHP (BE), HPRA (IE), ANSM (FR), BfArM (DE), MPA (SE), AGES (AT), FIMEA (FI), NLNA (NL), NOMA (NO), DKMA (DK), RAVIMIAMET (EE), EOF (EL), THE MEDICINES AUTHORITY (MT), INFARMED (PT), AEMPS (ES), JAZMP (SI), AIFA (IT), SÚKL (CZ), ZVA (LV), OGYEI (HU)
The FAMHP has taken on the role of co-coordinator for Work Package 5 (Capacity Building). Its main objectives are the recruitment and training of safety evaluators, the establishment of a mentoring programme and the sharing of experience and knowledge.
- EU4 Health 11 Programme (EU4H 11)
The EU4 Health 11 Programme has three main objectives.
- To strengthen the Joint Audit Programme (JAP) for Good Manufacturing Practice (GMP) inspections.
- To evaluate the national implementation of European legislation and directives on Good Distribution Practices and to develop a proposal for Good Distribution Practice within the existing Joint Audit Programme.
- To strengthen the capabilities of EU inspectors by developing harmonised training and qualification processes for GMP inspectors.
Participants: ANSM (FR), AIFA (IT), DKMA (DK), FAMHP (BE), HALMED (HR), INFARMED (PT), OGYEI (HU), SÚKL (CZ), MPA (SE), ZVA (LV), JAZMP (SI), HPRA (IE), VVKT (LT), PHS (CY), THE MEDICINES AUTHORITY (MT), ANM (RO), NOMA (NO), LYFJASTOFNUN (IS), MOHLUX (LU), ZLG (DE), AEMPS (ES), FIMEA (FI), EOF (EL), SÚKL (CZ), NLNA (NL), GIF (PL), RAVIMIAMET (EE), BGA (BG)
The FAMHP is a beneficiary partner within this programme. The Directorate General for Inspection will participate in training for qualified JAP auditors and, in a second phase, as a member of an audit team in a JAP EU Member State.
- CHESSMEN
CHESSMEN is a collaboration between 27 authorities within the European Union and the European Economic Area. The aim of the project is to harmonise the response to shortages of medicinal products between the competent authorities of different Member States, in order to reduce these shortages in Europe.
Participants: BfArM (DE), FAMHP (BE), HALMED (HR), PHS (CY), DKMA (DK), SÚKL (CZ), RAVIMIAMET (EE), ANSM (FR), BMG (AT), OGYEI (HU), HPRA (IE), MOHLUX (LU), NLNA (NL), NOMA (NO), INFARMED (PT), MS (RO), JAZMP (SI), AEMPS (ES), MPA (SE), FIMEA (FI), ESSC (LT)
The FAMHP will fulfil the role of coordinator of Work Package 3 (Evaluation). The main objective is to evaluate whether the project has delivered the planned outcomes and benefits and has brought about the desired change (evaluation of process, outputs and outcomes).
- IncreaseNET
The partners taking part in this project (mainly national competent authorities) will work together to seek a solution to the lack of capacity within the European regulatory network, which, amongst other things, is a result of the increasing workload and rapid scientific developments. Promoting cooperation and the distribution of work can, among other things, ensure the more efficient use of current resources.
Participants: JAZMP (SI), HALMED (HR), MMA (MT), DKMA (DK), HPRA (IE), BfArM (DE), PEI (DE), MPA (SI), ANSM (FR), AGES (AT), FAMPH (BE), MOH CY-PHS (C), SUKL (CZ), SAM (EE), FIMEA (FI), OGYEI (HU), AIFA (IT), SMCA (LT), CBG-MEB (NL), NOMA (NO), MUL (PL), INFARMED (PT), NAMMDR (RO), SUKL (SK), AEMPS (ES), SECMOH (UA)
The FAMHP is coordinating action point 7.3: this involves exploring opportunities to ensure the efficient use of resources, such as the distribution of work and avoiding the same work being repeated.
- JAMS 2.0
JAMS 2.0 aims to reinforce the market surveillance of medical devices between Member States and to harmonise approaches across the European Union.
By strengthening coordination, the project will help increase the safety of medical devices, thereby effectively contributing towards the protection of public health, in part by ensuring that medical devices available on the market are safe, work as intended and continue to comply with applicable regulations.
Participants: ANSM (FR), AGES (AT), FAMPH (BE), MoH-HR (HR), CYMDA (CY), SUKL (CZ), DKMA (DK), HB (EE), FIMEA (FI), BfArM (DE), EOF (EL), NIPN (HU), LYFJASTOFNUN (IS), HPRA (IE), the Italian Ministry of Public Health (IT), MMA (MT), NLNA (NL), NOMA (NO), URPLWMIPB (PL), INFARMED (PT), NAMMDR (RO), JAZMP (SI), AEMPS (ES), FCSAI (ES), MPA (SE).
The FAMHP will act as lead beneficiary for Work Package 6 (Inspection), the main objectives of which involve harmonising inspection activities across Europe, conducting joint inspections according to the developed framework and training inspectors according to that framework. The FAMHP will also participate in Work Package 5 (Signal detection in the area of medical device vigilance), Work Package 7 (market surveillance campaigns) and Work Package 8 (Medical devices and in vitro devices University for Competent Authorities).
- JAMRAI-2
EU-JAMRAI 2 (Joint Action Antimicrobial Resistance and Healthcare-Associated Infections 2) builds on the experiences and results of the first EU-JAMRAI project (2017-2021). The project supports Member States and associated countries (ACs) in their efforts to develop and update their national antimicrobial resistance (AMR) action plan.
The project contributes towards several of EU4Health's policy priorities:
- To strengthen coordination between Member States and ACs to combat AMR (a serious cross-border health threat);
- to strengthen the responsiveness of healthcare systems to AMR;
- to ensure access to key medicines and medical devices to combat AMR;
- to protect people from AMR.
In line with the 2017 European Union AMR One Health Action Plan, the project also promotes capacity building among Member States/ACs and aims to establish Europe's approach as a model in the fight against AMR.
The FAMHP will participate in this project along with the FPS Public Health as the designated competent authority.
- VetAMRTool
As part of the effort to combat antimicrobial resistance (AMR), European Regulation 2019/6 imposes a requirement for the use and sale of antimicrobial drugs in animals to be monitored. In order for Member States to collect and submit this data to the European Medicines Agency (EMA), competent authorities are being helped to set up a national data collection system.
In Belgium, a system will be developed, in which all data concerning antimicrobial drugs will be uploaded from a veterinary surgeon's IN and OUT register to the FAMHP.
- ERAMET
ERAMET (Ecosystem for rapid adoption of modelling and simulation methods to address regulatory needs in the development of orphan and paediatric medicines) aims to provide an integrated approach towards the decision-making by developers and regulators concerning paediatric and orphan medicines. This will consist of a transparent drug development and evaluation system that will facilitate the application of modelling and simulation (M&S) methods and related data types (including data from sources such as registers and electronic health records).
The overall objective of ERAMET is to provide and implement a framework for establishing the reliability of M&S methods and related results as sources of evidence within regulatory processes.
Participants: UNamur (BE), SRLAB (NO), CERTARA (UK), FAMPH (BE), UoW (UK), UV (ES), UCL (UK), CVBF (IT), FGB (IT), UMCG (NL), UNICT (IT), ARIDHIA (UK), APARITO (NL), ANSM (FR), CBG (NL), EBSN (BE), AEMPS (ES)
The FAMHP will act as the lead participant for Work Package 7 (Dissemination, Exploitation and Communication). The main objectives of this package are:
- to inform all stakeholders about the project's outcomes and the potential impact of those outcomes on research, clinical, industrial, regulatory and societal users;
- to unlock the full potential of the project's outcomes and increase awareness of the opportunities offered by the integrated model;
- to organise targeted communication actions to maximise the project's impact on society and on patient communities.
2. Past projects
- STARS
- EU-STANDS4PM
