Directorate General
PRE authorisation
competent for all activities prior to approval of the first marketing authorisation for a medicine or a health product
Research and Development Division (human use)
Clinical trial authorisations
130 under the Directive and 492 under the Regulation, including 134 transitional trials. Includes 15 vaccine trials: 4 under the Directive and 11 under the Regulation, including 1 transition trial (see also Spearheads – Vaccine Coordinator).
2 926
substantial changes or amendments closed
2 301 under the Directive (including 393 under the CTR (Clinical Trials Regulation) pilot project) and 231 under the Regulation.
Compassionate use and medical need programmes
Questions concerning clinical trials or research and development
1 021
questions concerning clinical trials or research and development
Annual safety reports
998
annual safety reports under the Directive
106
new indications as safety assessment Member State under the Regulation
Clinical investigations of medical devices
New
In 2023, we entered a new period of transition from clinical trials to CTRs. From February 2023, it became compulsory to submit new trial applications via CTIS (CTR), while submission via the Directive was no longer possible for initial trial applications (only substantial modifications).
Trend
With regard to compassionate use programmes (CUP/MNP), based on 26 approved programmes and an average programme duration of two years, it is estimated that some 2 908 patients will have free access to a medicine in a new, as yet unapproved indication. 44 % of these approved programmes are in oncology/haematology.
Marketing Authorisation Division (human use)
Files for obtaining marketing authorisation
New
Concerning new marketing authorisations via the centralised procedure, Belgium was rapporteur or co-rapporteur for 2 ‘full application, complete* files’ and 1 application for a biosimilar, and participated in 3 ‘multinational assessment teams’ (MNAT)**
*a full application, complete file’ is a file containing the necessary administrative, quality, non-clinical and clinical data.
**the ‘multinational assessment team’ makes it possible to set up an assessment team from different competent national authorities.
Homoeopathic medicines
Herbal medicines
Medicines for Veterinary Use Division
Clinical trial authorisations
Files for obtaining marketing authorisation
Variations
1 076
variations not requiring assessment
Procedures for marketing authorisations or variations
New
The UPD (Union Product Database) continues to have an impact on the Veterinary Division in terms of file management (reception and closure). In 2023, the start-up of DTS production also had an effect on the division’s performance. Staff are using new working instructions that will enable them to use DTS in a harmonised way.
Trend
Marketing authorisation holders have made increasing use of the VNRA (Variation Not Requiring Assessment) system, and the number of VNRA dossiers submitted has doubled compared with 2022. The number of VRA (Variation Requiring Assessment) files increased by 40 %. The number of applications for new marketing authorisations remained on a par with last year. At present, Belgium does not have the capacity to assume the role of RMS (Reference Member State) for new marketing authorisation applications. The mutual recognition procedure accounts for the bulk of files, mainly due to the high number of VNRAs.
Assessors Division
Medicinal products for human use
Medicines for veterinary use
New
The most important innovation for assessors in 2023 was the obligation to process clinical trial applications submitted via the CTR (Clinical Trials Regulation). This certainly played an important role, given that in 2023 the FAMHP was the Reference Member State for a large proportion of multinational applications and that the workload for processing applications under the CTR was higher than for applications submitted under the old legislation.
Trend
For veterinary medicines, there was a significant increase in the number of applications processed for variations. This is a consequence of the obligation to convert existing medicine product information to the current QRD (Quality Review of Documents) model.
National Innovation Office and Scientific-Technical Advice Unit
National scientific-technical advice
Simultaneous national scientific advice
Questions
Meetings
Consultation procedure for medical devices with a medicinal product as an integrated part of the medical device
TSE consultation procedure
Borderline product consultation procedure
European requests for scientific advice
New
– Project information and portfolio meetings with the FAMHP National Innovation Office, which until now had been offered exclusively for the medicines sector, were opened up to developers of medical devices and in vitro diagnostics (IVD) to develop support for innovation in the MedTech sector in Belgium and thus facilitate accelerated access to innovative medical technologies and patient-friendly IVDs.
In 2023, the FAMHP National Innovation Office continued to develop its collaboration with the Commission for International Cooperation in Health ‘CIS Health’ to establish a partnership with funding bodies in Belgium and consequently support non-commercial (pre-)clinical research in Belgium in a more targeted way.
Trend
After a downward trend in 2021 and 2022, more applications for advice were received in 2023 (of which 26 % related to the FAMHP’s vaccines area of excellence). The increase is mainly visible in the number of SNSA applications. This is the result of a more harmonised procedure and greater awareness thanks to active and passive communication through various channels. In addition to providing broader support for drug developers, the SNSA procedure also enables better communication between the different national medicines agencies.
The significant increase in the number of TSE consultation procedures (48 % compared to 2022) is a consequence of the implementation of the Medical Device Regulation (MDR) and indicates that it is being effectively followed.
Pharmacopoeia/Raw Materials Unit
Pharmacopoeia/Raw Materials Unit
Raw materials for pharmacy-made and officinal preparations
including
including
