New
Audits formerly called “internal audits” are now called “quality audits” to distinguish them from internal audits conducted by the Federal Internal Audit Service.
Menu
with the general support services of the agency which fall directly under the Chief Executive Officer
The Strategic Coordination provides transversal policy support to the Executive Council on strategic issues. All activities are carried out in support of and after validation by the Executive Council. This new service has been developing incrementally since 1 September 2022.
The Strategic Coordination seizes signs of innovation and change to anticipate strategic choices. These are some of its core tasks:
The goal is to support an internal dynamic within the FAMHP and contribute to a strong position of the agency, both on the national and international stage.
A strategic case developed in 2022 analysed internally the proposal for a regulation of the European Parliament on standards of quality and safety for substances of human origin intended for human application.
Requests handled through the ServiceNow ticketing system
Applications by entity
Activities (in number of hours)
Expenses | Budget 2022 | Implementation 2022 | Balance 2022 | Percentage |
|---|---|---|---|---|
Personnel expenses | 55 386 402 | 48 643 176 | 6 743 226 | 88 % |
Other personnel costs | 708 507 | 597 755 | 110 752 | 84 % |
Sciensano’s expertise | 6 999 590 | 5 735 753 | 1 263 837 | 82 % |
Other expertise | 1 964 395 | 1 172 642 | 791 753 | 60 % |
ICT investments | 9 702 495
| 11 975 776
| – 2 273 281
| 123 % |
Other investments | 7 563 393
| 2 643 425
| 4 919 969
| 35 %
|
Allocation 1FM | 2 608 684 | 2 608 684
| 0 | 100 % |
ICT capital expenses | 159 778
| 53 555 | 106 223 | 34 % |
Non-ICT capital expenses | 225 374 | 177 286 | 48 088 | 79 % |
Subsidies for NAT blood tests | 8 487 969 | 6 099 176 | 2 388 793 | 72 % |
Subsidies and other expenses | 12 164 622 | 12 126 180 | 38 442
| 100 %
|
Reimbursements to the Federal State | /
| 5 387 289 | – 5 387 289
| /
|
1 059 712 | 97 220 696 | 8 750 513 | 92 % |
*ICT Information and Communication Technology
**1FM Joint Facility Service of the FAMHP, the RIZIV-INAMI and the FPS Health
***NAT Nucleic Acid Amplification Test – Blood test using the nucleic acid amplification technique
Revenue | Budget 2022 | Implementation 2022 | Balance 2022 | Percentage |
|---|---|---|---|---|
Fees for medical devices | 14 281 825 | 11 677 040 | 2 604 785 | 82 % |
Fees for packaging | 17 505 171 | 13 670 150 | 3 835 021 | 78 % |
Fees authorisations | 7 970 845 | 5 851 632 | 2 119 213 | 73 % |
Fees inspections | 5 443 294 | 5 170 865 | 272 429 | 95 % |
EMA revenues | 5 984 418
| 7 790 868
| – 1 806 450 | 130 %
|
Revenues from clinical trials | 4 977 277
| 4 244 987 | 732 290 | 85 %
|
Revenues from registrations | 10 336 002 | 9 779 310 | 556 692 | 95 % |
DSUR revenues | / | 1 016 594
| – 1 016 594 | / |
Revenues from clinical research | 2 548 936 | 952 774
| 1 596 162
| 37 %
|
RIZIV-INAMI revenues | 3 287 860 | 3 269 860 | 18 000
| 99 %
|
Other revenues | 6 012 514 | 6 273 550
| – 261 036
| 104 % |
Allocation | 27 623 067
| 27 523 067 | 100 000 | 100 % |
105 971 209 | 97 220 696 | 8 750 513 | 92 % |
*EMA European Medicines Agency
**DSUR Development Safety Update Report
The number of press questions answered declined sharply in 2022. In 2021, the Communication Division answered as many as 928 press questions, most of which were about the coronavirus crisis.
Top 5 of the most frequently asked press questions in 2022:
Henceforth, there are no mandatory paper processes within the Legislation and Litigation Division. The transition to a paperless way of working is almost complete.
The Legislation and Litigation Division worked on important public health legislation in 2022. The division also observed a further increase in the number of requests relating to the public nature of administration.
In July, August and September 2022, the FAMHP welcomed 34 job students. The job students were set to work within various agency divisions and at the One Facility Management (1FM). The number of students in each language group was equally divided: 17 French-speaking and 17 Dutch-speaking job students. The job students were on average 18 years old.
Audits formerly called “internal audits” are now called “quality audits” to distinguish them from internal audits conducted by the Federal Internal Audit Service.
On November 28, 2022, Belgium notified the Grand Duchy of Luxemburg that the internal procedures had been completed within the scope of the Cooperation Treaty on medicines and health products between Belgium and the Grand Duchy of Luxemburg. The Consent Act was published in the Belgian Official Gazette on December 27, 2022.
Regulation (EU) 2022/123 on crisis preparedness and management for medicinal products and medical devices was published in 2022.
European negotiations were also launched on the proposals for a regulation on standards of quality and safety for substances of human origin intended for human application.
Within the scope of development cooperation, a framework agreement for medicinal and health products was signed on May 30, 2022 with Enabel. This agreement creates the possibility of entering into specific agreements for development cooperation projects implemented by Enabel.
In 2022, the International Relations Unit began preparations to ensure the Belgian presidency of the Council of the European Union in 2024. One of which was to set up a working group to discuss unmet medical needs. To prepare for the presidency, the FAMHP organised an event in 2022, namely a meeting of the Clinical Trial Coordination Group (CTCG) of which the FAMHP was vice-chair.
The Project and Portfolio Management Office (PPMO) Coordination supported several projects with different objectives selected by the Executive Council.
Most projects prepare our agency for new European legislation such as Regulation (EU) 2019/6 on veterinary medicinal products, Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
Other projects have been launched on the initiative of our agency and aim primarily to improve our services to the public. For example, the launch of a new module on the FAMHP web portal, for the registered pharmacist in charge of a pharmacy open to the public (digitalisation of the inspection cycle) or the launch of a second version of the SMT platform (‘stock monitoring tool’). This tool allows the agency to monitor the evolution of medicinal product stocks kept by certain key players in order to act more effectively against the risk of unavailability.
As technology evolves, the FAMHP also needs to update a number of applications. Our old medicinal product management system (Mesea) is being replaced by MPM (Medicinal Product Management) and HIRS (Health Intelligence Reporting System). This project will be completed in 2023 with the implementation of the Dossier Tracking System (DTS).
The FAMHP coordinates a joint action, called CT-CURE, initiated by the European Commission (EC). This joint action aims to jointly and simultaneously accelerate clinical trial procedures in several European countries, while maintaining patient safety. This initiative is co-funded by the EC.
of which
Follow us
