Innovation Meets Regulation: The role of the National Innovation Office of the Federal Agency for Medicines and Health Products

Are you working on clinical research project? Are you working in an SMEs, university, academic hospital, spin off? Do you need information about regulatory requirements? Get the experienced eyes of experts on your pharmaceutical product development to avoid pitfalls on your innovation journey.

What is FAMHP?

The Federal Agency for Medicines and Health Products (FAMHP) is the Belgian competent authority in charge of ensuring the quality, safety and efficacy of medicines and health products (medical devices and accessories, raw materials, blood and blood components of human origin, human tissue material), for human and veterinary use, in clinical development and on the market.

What does the National Innovation Office of FAMHP do for you?

The National Innovation Office at the FAMHP facilitates and supports innovation in pharmaceutical and medical technologies research and development (R&D) in Belgium and the communication with the innovators.

It is intended to serve as the central access point to the existing scientific and regulatory expertise of FAMHP both for human and veterinary medicines and therapies.

For whom does the National Innovation Office of FAMHP provide services?

The National Innovation Office is accessible for pharmaceutical companies, small and medium-sized enterprises (SMEs), academic research centers, spin-offs, academic hospitals and individuals who are actively involved in pharmaceutical innovation in general and particularly in research and development of new medicines and therapies.

What are the core activities and services of the National Innovation Office?

• National scientific, technical and regulatory advice

Request national scientific, technical and regulatory advice (STA) related to the research and development aspects of human or veterinary medicines in view of future clinical trial applications, marketing authorisation applications, introduction of variations to marketed medicines or line extensions.

For instance: Pharma advice procedures (e. g. patient involvement; joint scientific-HTA advice), Medical devices, IVDs, borderline & Drug-Device combination products, Blood, cells and tissues.

For SMEs, academic research centers, spin-offs and academic hospitals, the National Innovation Office foresees specific pre-submission STA assistance to guide the innovators during the preparatory phase of an STA application.

• Simultaneous National Scientific Advice (SNSA)

It is an EU pilot project to strengthen early regulatory support for innovation.

Get national scientific advice from multiple National Competent Authorities (NCA) at an early stage of development at the same time.

The SNSA pilot has a specific focus on, but is not limited to, scientific advice to facilitate multinational clinical trials within Europe. It facilitates sponsors and developers to obtain clinical trial-related national scientific advice from NCAs in the Member States where they intend to perform clinical trials.

The experience gained during the SNSA pilots will be used to further develop the process and the provision of consolidated clinical trial-related advice under the Accelerating Clinical Trials in the EU (ACT EU) initiative which aims to develop the European Union further as a competitive center for innovative clinical research.

• Specific support to SME’s, start-ups and academic research centers/hospitals:

Engage with the FAMHP in high-level and informative meetings (portfolio meetings) and have informal discussion on the potential critical issues related to R&D aspects of new innovative medicines, medical technologies and therapies, prior to potentially engaging in formal procedures such as scientific advice.

Prior to formal STA procedures and for SMEs, academic research centres, spin-offs and academic hospitals, present a specific clinical research project intended to be initiated at an early stage. The objective of these Project Info Meetings is to create awareness about particular uncertainties or the feasibility of the project which can facilitate further project planning, thereby increasing the chances for success. If needed (e.g. for discussing specific scientific or regulatory questions in depth) the applicants will be advised to request formal national, simultaneous and/or European scientific advice and/or guided to the appropriate procedures and services at national or European level.

Note: There is a 75% fee reduction for STA fee concept for SME’s and academia. Full (standard) fees available on the FAGG webpage documents: https://www.famhp.be/sites/default/files/2025_STA-EN.pdf cfr. https://www.fagg.be/nl/items-HOME/bijdragen

• Medical Devices/technologies & In-vitro Diagnostics

Similar to innovators of medical products, medical device and in-vitro diagnostic developers can request a project info meeting or a portfolio meeting to present their project or product pipeline, respectively.

Legend : MP = Medical Products, MD/ IVD = Medical Device/ In Vitro Diagnostic, HBM = Human Body Material (blood, cells and tissues from human origin)

What is the relation between FAMHP and the European Medicines Agency?

FAMHP, as a national regulatory authorities, and more specifically its Innovation Office is part of the European Medicines Regulatory Network together with the European Commission, the European Medicines Agency and approx. 50 others national regulatory authorities. Their mission is to support the EU Regulatory network strategy in facilitating the development of innovative medicines and technologies for drug development across Europe by addressing gaps in early regulatory support to innovation.

The FAMHP’s National Innovation Office functions as a local hub and direct interface with the EU-IN and EMA for any issues or queries from local innovators which may need further support and guidance at the European level.

In which EU legislative proposals is the National Innovation Office involved?

The National Innovation Office is involved in EU pharmaceutical legislation revision such as the Regulatory sandboxes or the borderline products, the SoHO Regulation (legislation related to the use of blood, tissues, cells and organs in medical therapies), the Health Technology Assessment (summarises information about medical, economic, social and ethical issues related to the use of a health technology), the AI Act or EU Research and Innovation support policies.

Is it mandatory to contact the FAHMP prior to initiating a clinical trial?

FAMHP involvement in a clinical trial assessment depends a number of factors, the most important ones are:

1. If the clinical study is legally subject to Clinical Trial Application (CTA) submission under the EU Clinical Trials Regulation (including formal CTA submission to regulatory authorities like FAMHP  and not only the ethics committees);
2. It also depends in general on the fact if Belgium is being proposed (by the CTA sponsor/applicant) and subsequently appointed (via the CTIS platform which is the central European IT platform for all CTA submissions in the EU) as either the Reference Member state (RMS) or Concerned Member State (CMS). Only when Belgium takes up one of these formal roles, then the FAMHP will be involved in the CTA assessment procedure.

All info on the different timelines that are applicable in BE for the different types of clinical trials and assessment thereof in Belgium (most of which are layed down in the EU Clinical Trials Regulation) can be found on the following webpage : https://www.famhp.be/en/human_use/medicines/medicines/research_development/clinical_trials

Feel free to contact the FAHMP R&D division in case of questions: ctr@fagg-afmps.be

In a nutshell, the National Innovation Office:

• Accelerate the translation of basic science and medical technologies to (pre)clinical research
• Facilitate the access to innovative drug and health care products to patients
• Maintain an attractive Belgian ecosystem for clinical research & attract in new (pre)clinical research
• Act as a key interface with EU Networks and other EU/national bodies and help navigate innovators through the complex EU regulatory system

Note of your Health National Contact Points and Enterprise Europe Network advisors

Knowing and engaging with this actor is relevant in the context of your innovation product or device development. Several open Horizon Europe Cluster Health topic calls for proposals (deadline: September 16th) involve clinical trials or the use/development of medical products, such as:

• HORIZON-HLTH-2025-03-IND-03-two-stage: Facilitating the conduct of multinational clinical studies of orphan devices and/or of highly innovative (“breakthrough”) devices
• HORIZON-HLTH-2025-03-ENVHLTH-01-two-stage: The impact of pollution on the development and progression of brain diseases and disorders
• HORIZON-MISS-2025-02-CANCER-04: Investigator-initiated multinational earlystage innovative clinical trials for paediatric cancer
• HORIZON-MISS-2025-02-CANCER-05: Pragmatic clinical trials to enhance the quality of life of older cancer patients (65 years and older) through nutrition

If you submit an application involving a clinical studies, you should, if not must, include an annexe titled “Information on clinical studies” (available here: EU Funding & Tender Portal > Guidance & Documents > Templates & Forms > Application forms). This document should outline whether you have sought advice from relevant regulatory and health assessment bodies.

An Annotated Template has been developed by the EU Health NCP Network (HNN3.0). You can download this document here.

Sources:

• https://www.famhp.be/en/innovationoffice
• Flyer “The National Innovation Office of the FAMHP” https://www.famhp.be/sites/default/files/National_office_innovation_EN_2023_PRINT_0.pdf
• Extract of PowerPoint slides from Christophe Lahorte, Head of Innovation Office & Scientific-Technical advice Unit, FAMHP
• EU Funding & Tenders Portal: https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/home

Contacts:

National Innovation Office of FAMHP: innovationoffice@fagg-afmps.be

Cluster Health/Mission Cancer National Contact Points, NCP Brussels: Marie-Elisabeth Colin and Emilie Fonck (mecolin@hub.brussels; efonck@hub.brussels).

18.06.2025