The Chief Executive Officer’s Services include four divisions:

• Communication;
• Legislation and Litigation;
• Quality and Organisational Management;
• International Relations;

and the Strategy Realisation Office, created in 2024.

The Chief Executive Officer’s Services play a key role in the management and supervision of the agency. They ensure the strategic coordination and proper functioning of the FAMHP in liaison with the public authorities and stakeholders in the healthcare sector.

Their main tasks are:

• Strategic and organisational management by defining the FAMHP’s strategic directions in line with public health policies.
• Implementing the agency’s objectives.
• Monitoring regulations and drafting legal opinions, while ensuring the legality of the agency’s actions.
• Institutional representation by acting as a point of contact with the government, European bodies and other stakeholders.
• Communication and transparency by providing information to the citizens, healthcare professionals and pharmaceutical companies.

• 287 answers to press questions recorded
• 220 internal newsletters
• 99 news items on the website
• 1 366 436 visits to the website

The Directorate General POST authorisation is organised into four divisions:

• Marketing Authorisation Division (variations and renewals);
• Vigilance;
• Health Products;
• Proper Use;

and the Human Body Material Unit.

The Directorate-General POST authorisation (DG POST) is responsible for all activities following the first marketing authorisation for a medicine or a health product. Its missions include managing authorisation renewals and variations, monitoring adverse effects (pharmacovigilance), tracing medical devices (materiovigilance) and managing stock shortages and unavailabilities.

It is represented in various European committees and working groups active in the field of vigilance and proper use of medicines and health products, enabling it to stay informed of the latest developments concerning medicines, medical devices and human body material.

The Directorate General Inspection is made up of five divisions:

• Industry;
• Distribution;
• Dispensing;
• Authorisations;
• Medical devices;

and the Special Investigation Unit.

The directorate General (DG) Inspection ensures market surveillance by:

• organising inspections and checks of the manufacture, distribution, dispensation and advertising of medicines and health products to guarantee their quality;
• granting authorisations and certificates following inspections and checks (authorisations, certificates, licences, accreditations, etc.);
• organising investigations and assisting with investigative duties in the fight against illegal practices.

DG Inspection implements a market surveillance strategy as its control policy, supported by a customer-focused administration. Furthermore, we are committed to using internal resources and new technologies more efficiently, while also strengthening our approach to pharmaceutical crime at both national and international levels.

Inspections

• 71 good manufacturing practice inspections
• 37 good clinical practice inspections concerning medicines

Analyses of products on the market

• 163 medicines
• 137 preparations
• 22 raw materials
• 135 products seized
• 8 medical devices

Inspections 

• 41 routine inspections concerning good distribution practices
• 10 routine thematic inspections concerning good distribution practices
• 93 inspections concerning good distribution practices for medicines for obtaining or amending a distribution authorisation
• 2 inspections of advertising and other promotional activities
• 18 pharmacovigilance inspections
• 45 inspections of human body material establishments
• 11 inspections of establishments importing human body material
• 10 thematic inspections of depots for human body material
• 14 inspections of blood establishments and donation centres
• 3 thematic inspections blood (mobile collections)

Investigations

• 60 investigations concerning the distribution of medicines
• 16 checks and 91 investigations on advertising and other promotional activities for medicines
• 8 pharmacovigilance inspections
• 10 human body material investigations                                                                  

Scientific and legal questions concerning good distribution practices

• 526 responses to scientific and legal questions concerning good distribution practices
• 42 responses to scientific and legal questions concerning human body material and blood
• 102 responses to questions on advertising and other promotional activities

Inspections

• 486 pharmacies open to the public (92 of which regarding the operating licence)
• 21 reinspections of pharmacies open to the public
• 45 hospital pharmacies for medicines
• 5 reinspections of hospital pharmacies for medicines
• 550 veterinary depots

Investigations

• 150 investigations on the dispensing of medicines (administrative files)
• 136 investigations on the dispensing of medicines (legal files) 

Questions

• 3 499 questions on the dispensing of medicines 

Hormones and antibiotics

• 49 new authorisations
• 116 renewals
• 138 amendments of authorisations
• 4 letters of no objection

Narcotics and psychotropic substances 

• 24 new annual activity authorisations, 8 of which with inspection
• 83 amendments to annual authorisations
• 5 146 authorisations for import and export
• 827 inspections as part of import and export authorisations
• 5 additional inspections
• 112 new or renewed end-user authorisations
• 14 amendments of end-user authorisations
• 57 letters of no objection
• 601 validations of Schengen declarations
• 492 open Narcoreg files
• 10 reports
• 62 destruction inspections
• 9 scope activity inspections
• 7 suspensions of activity licences
• 3 suspensions of end-user authorisations

Precursors

• 13 new authorisations
• 95 renewals or amendments
• 7 import authorisations
• 1 041 export authorisations
• 49 suspicious orders and transactions
• 19 inspections of authorisations

Manufacturing and distribution authorisations

• 204 authorisations for the manufacturing/distribution of medicines
• 55 registrations for the import/manufacturing/distribution of pharmaceutical raw materials
• 11 certified copies
• 365 certificates for good manufacturing practices/good distribution practices
• 2 583 copies of certificates for good manufacturing practices/good distribution practices, authorisations for the manufacturing/distribution or registrations for the manufacturing/distribution of pharmaceutical raw materials
• 1 332 certificates for pharmaceutical products, including 168 urgent applications
• 1 481 e-legalisations of documents
• 160 export declarations

Human body material and blood establishments

• 65 accreditations for human body material establishments
• 29 preliminary accreditations for human body material establishments
• 4 amendments to accreditations for human body material establishments
• 35 accreditations for establishments importing human body material
• 17 accreditations of biobanks

Pharmacies open to the public

• 1 064 cadastral registration forms of pharmacies open to the public
• 323 location decisions

Pharmacists-clinical biologists

• 21 authorisations of pharmacists-clinical biologists

Depositary veterinarians

• 393 notifications of a veterinary depot

• 12 inspections concerning good clinical practices involving medical devices
• 96 inspections of manufacturers of medical devices in Belgium
• 6 reinspections of manufacturers of medical devices in Belgium
• 1 inspection of notified bodies abroad
• 6 inspections of notified bodies in Belgium
• 221 inspections of medical device distributors
• 15 inspections of hospitals concerning medical devices (including sterilisation divisions)
• 7 inspections of European authorised representatives
• 33 inspections of importers
• 1 inspection as an expert for Belac (Belgian Accreditation Body under the authority of the FPS Economy, to which Belgian companies and organisations can turn to obtain accreditations)
• 5 inspections as part of the BEL-LUX cooperation
• 327 investigations into medical devices
• 300 questions about medical devices

• 582 closed investigations into illegal medicines in illegal circulation
• 34 investigations into illegal health products in illegal circulation
• 142 cases in which assistance was provided to police and public prosecutors
• 423 cases of advice given to other (domestic and foreign) authorities
• 3 766 blocked postal packages sent from outside the European Economic Area to a Belgian addressee. The packages contained non-compliant medicines, medical devices and in vitro diagnostics.
• 308 controls of consignments in transit (destined to another EU Member State)

The General Services were created in 2024. They include the following divisions:

• Budget and Management Control;
• Personnel and Organisation;
• ICT;

and the Logistics Unit – Collaboration 1FM.

The Logistics Unit was created in the same year to support the administrative monitoring of the FAMHP’s own public procurement contracts.

This unit provides administrative support for contracts exceeding 30 000 euros, and provides, on demand and in consultation, assistance for lower-value contracts.
It also provides answers to questions on legal and practical aspects of legislation.
Several changes took place in 2024.

• As of March 2024, electronic invoicing has been mandatory for contracts exceeding 3 000 euros.
• Small and medium-sized enterprises (SMEs) have been given greater access to public procurement contracts, which meant that the specifications had to be adapted.
• The circular of 17 May 2024 highlighted ethics and accountability in public procurement, especially in conflict-of-interest situations.

Though the majority of cases were resolved within three months, some medicines are persistently unavailable and that is a cause of concern, especially whenever life-saving or unique treatments are involved. Nevertheless, patients in Belgium are not being left to face this problem alone. Thanks to a combination of national interventions and cooperation at European level, the FAMHP is managing to limit the damage. But how does that work exactly?

Shortages of drugs and medicines in figures: increase halted, majority of shortages are short-term

First, a brief explanation is needed about how the FAMHP defines temporary unavailability. The FAMHP considers a medicine to be ‘unavailable’ whenever a specific packaging within three business days. For example, a box of 20 tablets of a particular brand is reported as unavailable but other packagings (such as a box of 50 tablets), other forms (such as syrup), or alternatives from other manufacturers may actually be available.

This puts the absolute numbers into perspective because, in most cases, the unavailability of a specific packaging does not have a major impact on patient treatment. In 2024, a particular packaging was actually unavailable in 1 214 cases (>36 %), but in each one, at least three alternatives with the same active ingredient, desired dosage and the same method of administration were available at all times. In 325 cases (10 %), one or two alternatives were available.

In 2024, a total of 3 321 reports of unavailability were therefore received. In 2023, the total number was still 3 841. Especially if we consider the sharply rising trend that occurred in the past few years, it is clear that this trend has now come to an end.

The figures also show that the majority of these unavailabilities are resolved relatively quickly. Of all of the unavailabilities resolved in 2024, one quarter were resolved within two weeks and just under three quarters were rectified within two months.

While this finding is positive, hundreds of shortages continue to occur each year and drag on for months or even turn into structural shortages. Medicines for which no alternatives are available or that exist in a unique pharmaceutical form, as they do in the case of paediatric applications, are especially challenging.

Reason why medicines are unavailable

When reporting an unavailability, manufacturers must provide a reason. In 2024, a delay in production was the cause in almost half of the cases of unavailability. Increased demand is the problem in 15 % of cases. Logistical problems or certain substances being unavailable are given much less frequently as the cause.

Conclusion: a long-term undertaking, but one that provides tangible results

Medicine shortages remain a fundamental problem that directly affects patients, pharmacists and physicians. Nevertheless, it is clear that the FAMHP is not sitting on the sidelines. Thanks to a combination of swift action, constructive consultations with the sector and extensive international cooperation, the agency is succeeding in addressing many shortages quickly or even proactively.

Vigilance and flexibility are, however, crucial. The medicine production landscape is fragile due to global dependencies and economic pressures on suppliers. The solutions that the FAMHP is now deploying – and which are taking shape at European level – are desperately needed in order to ensure that patients in Belgium continue to have access to the medicines they need.

It is in this background that the FAMHP organised its seventh Vigilance Day in December 2024. The main theme of this day was the potential of using applications driven by artificial intelligence in the field of pharmacovigilance.

Pharmacovigilance: detect, understand, prevent

Each medicinal product being placed on the market has undergone long rounds of previous tests. However, certain adverse reactions only appear once a medicinal product has been on the market for some time. Monitoring is therefore necessary, even after a medicinal product has been granted a marketing authorisation (MA). This is the role of pharmacovigilance.

Pharmacovigilance refers to the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions or any problem associated with medicines to ensure their safety after they have been placed on the market.

Marketing authorisation holders and governments of the member states of the European Union (EU) have specific obligations such as developing a system to encourage healthcare professionals and patients to report adverse reactions, documenting, evaluating and reporting adverse reactions to EudraVigilance and searching for possible new side effects (signals).

Eudravigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). MA holders must also appoint a responsible person for pharmacovigilance and send safety reports to the FAMHP.

This notification is essential to protect patients. It enables new adverse reactions to be detected more quickly, drug interactions to be identified, trends in the frequency of certain adverse reactions to be monitored, and the information needed to reduce risks and errors to be disseminated.

And what about AI in this process?

The FAMHP strives for active pharmacovigilance by making it easier to report adverse reactions and using AI to improve their treatment. AI enables the acceleration of medicinal products development and cost reduction, while also presenting challenges such as biases, privacy concerns, and the need for human oversight.

Practical use at the FAMHP 

When an adverse reaction is reported to the FAMHP, it is analysed by our experts, then encoded and sent to the European Medicines Agency, EMA.
In this process, the transcription of the text of a report into MedDRA terms (MedDRA is the Medical Dictionary for Regulatory Activities) by AI can relieve the agency and free up more time for scientific analysis of the data.

The prototype used at the agency is based on four pillars.

1. The large language model (LLM), which is capable of understanding and generating human language. It makes it possible to analyse, extract and classify information.
2. The embedding, which converts text into mathematical vectors.
3. A vector database, that draws comparisons and identifies relationships.
4. The prompting, that guides the LLM to produce precise and contextually relevant results.

The results are promising: 73 % accuracy! Although this is not enough to fully automate the process, this prototype is a good decision-making aid, suggesting terms and scores to the user.

We are only at the beginning of the process. Ultimately, the aim is to automate the process as far as possible and to upload adverse reactions to medicinal products into EudraVigilance.

Artificial intelligence at the service of patients

AI has the potential to revolutionise the development of medicinal products and their safety, regulatory processes, but also and above all public health. It enables large quantities of data to be analysed rapidly, the effects of medicines to be monitored more closely or to anticipate adverse reactions on the basis of historical or real-life data.

But AI is nothing without data. The quality and the quantity of reports are essential. This is why the FAMHP wishes to remind us of the importance of reporting side effects. Regulators, searchers, industry, healthcare professionals and patients, we all have a role to play. With sufficient data, properly supervised artificial intelligence and our expertise, we can improve the safety of medicines.

Optimising inspections: a new system for new practices

Good Manufacturing Practices (GMP) are the principles and guidelines for the manufacture of medicines for human and veterinary use. They are an essential pillar in guaranteeing the quality of medicines for human and veterinary use, and are part of the core tasks of the Industry Division. In 2024, this division benefited from the introduction of a new IT system.

Thanks to this new IT system, our inspectors now have a tool enabling them not only to carry out their tasks efficiently, but also to quickly and securely exchange data electronically with the pharmaceutical industry.

The system includes three key features.

1. An online module that allows the industry to browse sent data and information. At the same time, it offers the option to update some of the information and to communicate with inspectors.
2. A communication module between the online application and the module for inspectors.
3. A management application that allows inspectors to organise and track their missions efficiently.

The aim of this new inspection methodology is to optimise market surveillance and the efficiency of inspections, leading to greater transparency, a reduced administrative burden, modernised practices and strengthened collaboration between the FAMHP and the relevant stakeholders. With the ultimate goal: to guarantee patient safety.

Practical tools to meet practical needs

Digital modernisation is not limited to internal processes. Although the agency is actively working on modernising its internal tools to improve the management of medicines and medical devices, its mission goes far beyond.

The FAMHP’s mission is to ensure that every medicine or medical device used in Belgium is safe, effective and of high quality. As part of this process, the agency is mindful of the importance of providing information that is correct, understandable and easy to access.

Just as our website is accessible to professionals and citizens, with information tailored to each target audience, our applications follow the same logic.
PharmaStatus is a good example. This tool allows users to monitor the availability of medicines on the Belgian market in real time. Wholesalers, distributors, doctors, pharmacists and journalists can look up the situation on the Belgian medicine market in real time, find out whether a medicine is available or not, and whether alternatives are available.
This service is also available to patients. A quick search shows if a medicine is available, or if there are any alternatives. Of course, any alternatives should be discussed with a healthcare professional to adjust the treatment if necessary. But having the information in advance is a real advantage!

That is why PharmaStatus was given an update in 2024.

The interface has been completely redesigned so it is clearer and more in line with our other applications. The homepage now displays statistics in a more visual way, with easy-to-read infographics and figures shown in boxes.

In terms of content, the status ‘interruption of commercialisation’ was removed in order to align with European procedures. And the status ‘unavailability determined by the FAMHP’ has been added to ensure that the information is as up to date as possible.

And what about the patients? 

There are several applications available for patients, the best example is PharmaInfo. Although our website is accessible to the general public, within the FAMHP we wondered how to make the information even clearer and more accessible to patients and the general public ‒ a reflection that led to the launch of PharmaInfo.

PharmaInfo is an innovative web portal launched by the agency in December 2023. This website aims to provide citizens and patients with easily understandable, reliable information on medicines and health products. It’s a portal designed to explain, simplify and enlighten.

In 2024, no less than 110 medicine fact sheets, 4 medical device fact sheets, 15 new themes and 27 news items were published.
The aim is to make it easy for everyone to find reliable, up-to-date and understandable information, without needing a medical dictionary.

Digital technology: working towards a more accessible healthcare for everyone

Today, more than ever, the FAMHP is investing in modernising its digital services to enhance the safety of medicines and medical devices, and to improve the accessibility of information for everyone.

By providing modern, high-performance tools, the agency is reaffirming its commitment to professionals and citizens alike. This approach is helping the agency to increase its transparency, efficiency and responsiveness, with a clear aim: to better protect public health on a daily basis.

For many years our agency has been recognised at European and international level for its expertise in vaccines for human use (to protect people) and veterinary use (used in veterinary medicine to protect animals and, in some cases, public health). In recent years, the FAMHP has been heavily involved in this area. A prime example is our active participation in the rapid development of safe and effective COVID-19 vaccines for human use throughout the European Union.

In 2024, the FAMHP had a new opportunity to stand out in this field, this time in veterinary vaccines. Belgium is concerned about the presence in neighbouring countries of two viruses that could affect herds and the work of breeders.

Bluetongue: acting fast to counter the threat

Bluetongue (BT) disease is a virus that affects domestic (sheep, cattle, goats) and wild ruminants. Although harmless to humans, it can have serious consequences for animals. Several serotypes exist, including BTV3, which caused concern in Europe in 2024.

In response to this threat, the FAMHP accelerated its assessment of the available data on the quality, safety and efficacy of three vaccines (Bluevac-3, Bultavo 3 and Syvazul BTV-3). The aim was to provide rapid, effective solutions to the legitimate concerns of breeders while maintaining our high standards. Animals could be vaccinated under certain conditions, without waiting for the vaccines to obtain final marketing authorisation.

Epizootic haemorrhagic disease: another specific example

Epizootic haemorrhagic disease (EHD) is transmitted by the bite of Culicoides midges and affects cattle, deer and sometimes sheep. Again, although harmless to humans, this virus can affect the physical condition of animals. In 2024, to prevent the spread of the disease, the FAMHP approved the use of the Hepizovac and Syvac Marker vaccines under certain conditions, before they obtained final marketing authorisation. This was an essential preventive measure to protect animals.

A vital emergency procedure

Clearly, all these vaccines could not be used without a legitimate reason. The authorisations for use were issued under Article 110(2) of Regulation 2019/6. These temporary authorisations, issued for a fixed period or subject to conditions, were accompanied by the obligation to report adverse reactions to the FAMHP.

This procedure made it possible to react quickly, efficiently and safely to an urgent need in the field. Ultimately, it enabled vaccines to be used slightly sooner than expected pending full marketing authorisation. Four of these vaccines were granted marketing authorisation just a few months after being approved under the urgent procedure.

The work carried out on the BT and EHD vaccines, in compliance with quality, safety and efficacy rules, eliminated any risk of a major health crisis in the livestock sector and its consequences for breeders.

This underlines the importance of vaccines for veterinary use which provide many advantages.

Firstly, by boosting immunity against different pathogenic micro-organisms (mainly viruses and bacteria, but also protozoa and fungi), they can combat a wide range of infectious diseases in different target animal species (dogs, cats, cattle, pigs, hens, horses, etc.).

Secondly, they are the only effective response to most viral diseases. Certain vaccines for veterinary use are all the more important as they combat highly contagious diseases that have a dramatic impact on livestock. Examples include avian influenza, swine fever, foot-and-mouth disease and bluetongue.

Lastly, they also protect public health by combating the microbes responsible for zoonoses (i.e. diseases transmissible from animals to humans, such as rabies).

Continuous vigilance to guarantee safe vaccines

However, there are risks associated with the administration of certain veterinary vaccines.
The FAMHP ensures that all the risks are assessed before authorising a vaccine to enter the market. These risks are product-specific and assessed on a case-by-case basis: risks to the animal, the user, the consumer of animal products and the environment.

Every marketing authorisation (MA) application is examined in the light of both benefits and risks, with authorisation only granted to manufacturers when the former outweigh the latter.

Pharmacovigilance also plays an important role. FAMHP staff are constantly working to ensure that the products on the market are safe, effective and of good quality. To do this, they reassess the benefit-risk balance whenever necessary.

The agency wants to strengthen its role in the field of veterinary vaccines at both national and European level. As it already employs recognised experts in this field, the FAMHP has all the assets to become a reference for all aspects of the veterinary vaccine life cycle: scientific advice, clinical trial applications in Belgium and at European level, evaluation of marketing authorisation applications, pharmacovigilance and inspection aspects.

The FAMHP is aware of the major importance of veterinary vaccines for public health and will continue its involvement in this field, with a view to continuously improving the health of every Belgian and EU citizen.

Joining the FAMHP also means having the opportunity to grow in an environment where Belgian expertise shines internationally.

These commitments are perfectly in line with the third strategic objective of the FAMHP: “The FAMHP, a partner in today’s and tomorrow’s healthcare ecosystem”. It aims at strengthening our position and our influence in the international field. By having active representatives on European committees, we ensure that Belgium’s voice is heard and that our expertise is recognised and valued.

We would like to express our sincere appreciation to our colleagues, whether they are newly appointed or have since long represented the FAMHP internationally. Their unwavering commitment to promoting public health and pharmaceutical innovation in European bodies is exemplary. Thanks to their outstanding work, they contribute not only to achieving our strategic objectives, but also to enhancing FAMHP’s influence on the international scene.