Transversal support
with the general support services of the agency which fall directly under the Chief Executive Officer
Management Support
Management-support
Answered parliamentary questions
Organised meetings
ICT Division
Projects and Development Entity
Distribution by activity (in number of hours)
Operations Entity
Service Desk Team
Infrastructure Team
New
Our mission is to manage and implement the FAMHP’s ICT tools in line with the agency’s strategic objectives. We would like to thank all the FAMHP staff who helped us better understand their needs. This has enabled us to provide solutions that effectively support our users in their daily work.
With the development of Agile, we worked iteratively and collaboratively, actively involving our colleagues from other entities throughout the development cycle of each application.
The ICT division contributed to many projects this year.
- PharmaInfo
- Narcoreg
- Autocontrol in pharmacies
- Fertidata
- Data Tracking System
The first three projects mentioned above are described in the ‘In the spotlight’ section of this annual report.
Budget and Management Control Division
Expenses | Budget 2023 (euros) | Implementation 2023 (euros) | Balance 2023 (euros) | Percentage |
|---|---|---|---|---|
Personnel expenses | 65 733 105 | 60 711 628 | 5 021 477 | 92 % |
Other personnel costs | 720 926 | 681 080 | 39 846 | 94 % |
Sciensano’s expertise | 7 997 787 | 6 371 421 | 1 626 366 | 80 % |
Other expertise | 3 195 148 | 1 228 789 | 1 966 359 | 38 % |
ICT investments | 12 650 357 | 12 833 497 | -183 140 | 101 % |
Other investments | 4 939 565 | 3 354 610 | 1 584 955 | 68 % |
Allocation 1FM | 2 470 437 | 2 396 437 | 74 000 | 97 % |
ICT capital expenses | 212 639 | 11 268 | 201 371 | 5 % |
Non-ICT capital expenses | 183 547 | 331 084 | -147 537 | 180 % |
Subsidies for NAT blood tests | 9 901 249 | 9 901 249 | / | 100 % |
Subsidies and other expenses | 10 370 281 | 9 924 067 | 446 214 | 96 % |
Reimbursement to the Federal State | / | 3 333 459 | -3 333 459 | / |
118 375 041 | 111 078 590 | 7 296 451 | 94 % |
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 2023 (euros) | Implementation 2023 (euros) | Balance 2023 (euros) | Percentage |
|---|---|---|---|---|
Fees for medical devices | 15 510 345 | 16 334 721 | -824 376 | 105 % |
Fees for packaging | 18 408 450 | 19 494 186 | -1 085 736 | 106 % |
Fees marketing authorisations | 12 294 384 | 7 005 448 | 5 288 936 | 57 % |
Fees inspections | 6 057 025 | 6 580 799 | -523 774 | 109 % |
EMA revenues | 7 659 161 | 7 754 780 | -95 619 | 101 % |
Revenues from clinical trials | 4 731 061 | 3 627 035 | 1 104 026 | 77 % |
Revenues from registrations | 11 501 385 | 10 820 185 | 681 200 | 94 % |
DSUR revenues | / | 1 106 908 | -1 106 908 | / |
Revenues from clinical research | 2 029 749 | 564 892 | 1 464 857 | 28 % |
RIZIV-INAMI revenues | 3 617 751 | 3 599 750 | 18 001 | 100 % |
Other revenues | 6 282 468 | 5 137 303 | 1 145 165 | 82 % |
Revenues from European projects | 1 623 915 | 398 822 | 1 225 093 | 25 % |
Allocation | 28 659 347 | 28 653 760 | 5 587 | 100 % |
118 375 041 | 111 078 589 | 7 296 452 | 94 % |
EMA European Medicines Agency
DSUR Development Safety Update Report
New
- In the first half of 2024, Belgium will hold the presidency of the Council of the European Union. In this context, the FAMHP is taking numerous initiatives such as organising conferences. The agency has set up a cost accounting system to carefully track the expenses and revenues (allocations) resulting from this role.
- To ensure the correct and efficient collection of all fees and contributions due, the revenue accounting team worked to make invoicing procedures more efficient in 2023. A reminder module and the establishment of a partnership with FPS Finance will help the FAMHP to recover unpaid invoices and spread the financial burden fairly among all economic operators.
- The Belgian Pharmaceutical Association (APB) has an analytical laboratory whose activities contribute to the dispensing of quality medicines by pharmacies (and depositary veterinarians). This Medicines Control Laboratory (SCM) is financed by pharmacies. Their fees are proportional to the quantities of medicines they purchase. Companies supplying medicines to pharmacies report their sales quantities to the FAMHP each quarter and pay their contribution into a separate FAMHP account to finance the SCM. Since this is not the only tax on the number of packages sold, there has often been ambiguity in the past. In 2023, the FAMHP provided clear and complete information to all companies concerned. This immediately translated into a significant increase in revenue, and thus into fairer and more adequate funding for the SCM.
- After several years of preparatory work and consultation with representatives from the sector, the system for financing the market surveillance of actors operating in the medical devices sector was reformed in 2023. To compensate, an activity tax was introduced. The nature of the activities, the classes of medical devices involved and whether or not they participate in the autocontrol programme largely determine the contribution of each actor, reflecting the risk to public health and the workload for the FAMHP. At the same time, we reduced the annual turnover tax by a quarter, removed the minimum contribution due and introduced a minimum threshold which will now mean that companies that have a limited turnover from medical devices are exempt from paying the turnover tax.
Communication Division
> 3 500
new followers on social media
Trend
In 2023, we received 33 % more press requests than in 2022. The average response time was half a day.
77 % of press questions were answered within one working day, and 17 % of press questions were answered after one working day.
Only 6 % of press questions were answered after more than one working day.
The questions most frequently answered concerned:
- medication shortages;
- temporarily unavailable medicines;
- Ozempic (unavailability, recommendations, side-effects, falsification).
Legislation and Litigation Division
70
litigation in progress, including 13 new cases arriving in 2023
Personnel and Organisation Division
Distribution by level
Distribution by language
Distribution by gender
Distribution by working regime
Staff turnover
New
In the distribution by level, we have also added ‘authorised representatives’ as a separate category, as provided for in the Royal Decree of 16 November 2006 on the designation and exercise of management and supervisory functions in certain public-interest bodies.
During the summer months of July, August and September 2023, we welcomed 35 student workers. The students were employed in the agency’s various divisions, as well as in 1FM’s support services. The linguistic distribution was proportionate: 17 French-speaking student workers and 18 Dutch-speaking student workers. The average age of the student workers was 18. For legal reasons, four external students were also recruited in 2023. These are students who are not family members of FAMHP staff.
Quality Division
Quality audits
Non-conformities in internal audits
Internal audit by the Federal Internal Audit Service
External complaints
Received complaints
Status of the received complaints
Distribution of complaints by entity
Quality documents
Types of new quality documents
Types of modified quality documents
New
The Network of Directors of European Medicines Authorities (HMA) is organising a fifth benchmarking exercise for the period 2022-2025, called Benchmarking of European Medicines Agencies (BEMA V). In 2023, the FAMHP participated for the fourth time in this improvement exercise. Learn more in this article.
Trend
In 2023, the ‘quality’ audit schedule was limited to mandatory audits. The organisation of BEMA V involved a large number of teams in this exercise to assess the management maturity of our services and activities.
International Relations Unit
International cooperation in 2023
New
2023 was an extraordinary year in more ways than one for the International Relations Unit. Preparations for the Belgian presidency of the Council of the European Union in the first half of 2024 were naturally a large contributor to this, but they are not the only important factor.
There was also intense legislative and political activity. On the legislative front, we reached agreement in less than one year on the revision of the regulation on fees payable to the European Medicines Agency, and finalised the Council’s position on the new SoHO regulation in less than eighteen months. It is also worth noting the adoption, in record time, of a proposed regulation amending the transition period of Regulations 2017/745 and 2017/746 for certain devices.
On the political front, Belgium stood out internationally as the driving force behind European action on medication shortages with the launch of a non-paper on medicines shortages (Non-paper – Improving the security of medicines supply in Europe), which was supported by 23 Member States and followed in October of the same year by a communication from the Commission (addressing medicines shortages in the Union).
Finally, the FAMHP continued and developed its bilateral activities with Luxembourg, following the entry into force of the cooperation agreement between the Kingdom of Belgium and the Grand Duchy of Luxembourg on medicines and health products in December 2022, and implemented the framework cooperation agreement on medicines and health products between the FAMHP and ENABEL through a specific agreement relating to support for the Senegalese Agency for Pharmaceutical Regulation to achieve and maintain WHO Maturity Level three.
Project and Portfolio Management Office Coordination
New
In 2023, ten projects were delivered or entered their final testing phase, including several major projects such as:
- The delivery of the basic functionalities of
- MPM (FAMHP central database for medicines);
- DTS (electronic dossier tracking application);
- HIRS (research and reports based on data from the two applications above);
- The digitisation/autocontrol of narcotics order forms (Narcoreg);
- The electronic document transmission and approval processes;
- The new quality system (replacing DMS Quality).
Other ongoing projects will continue to occupy our resources in 2024.
Spearheads
Early stage development
38 under the Directive and 120 under the Regulation, including 22 transitional trials
including
24 under the Directive and 56 under the Regulation, including 15 transitional trials
Oncology
45 under the Directive and 188 under the Regulation, including 74 transitional trials
Vaccines
4 under the Directive and 11 under the Regulation, including 1 transition trial (see also DG PRE R&D)
13 applications were approved, including 12 prophylactic vaccines
New
- The Vaccines Spearhead management group was relaunched with an increase in membership.
- Participation in Flanders Vaccine symposia, including ‘Immunity for Health’.
- Participation in IABS workshops:
- workshop on ‘Ethical approval for Controlled Human Infectious Models (CHIM) clinical trial protocols’;
- workshop on ‘The role of real-world evidence for regulatory and public health decision-making for accelerated vaccine deployment’.
- • Collaboration launched with the ‘Leading International Vaccinology Education (LIVE)’ MSc programme, offering internships to MSc LIVE students.
- • Launch of a project on knowledge of and attitudes towards Human Challenge trials.
