competent for all inspection and control activities
A new inspector was hired and coached in 2021. This led to an increase of about 30 % in the number of good clinical practices inspections compared to 2019. The additional inspections were mainly conducted in Belgium. The good clinical practices inspections focused primarily on clinical trials for medicinal products and vaccines against COVID-19. The outcome of these inspections was very good when it comes to quality. This proves that the Belgian researchers were very meticulous in their work.
The results for 2021 show that despite all the obstacles, the division’s routine work was carried out correctly and without any delays. The teams worked primarily on the access to new therapies, their safety and on maintaining the quality of traditional products. The teams also focused on larger projects such as the implementation of the new legislation on medicinal products for veterinary use and clinical trials. These activities took up a lot of time. This led, among other things, to a slowdown in the actual work done on, for example, the interpretation of specific cases and the standards to be applied to niche products. Nevertheless, all aspects were taken into account and the teams are now ready to work on these projects.
The COVID-19 crisis has brought many constraints. The production sites for the COVID-19 vaccines and the other medicinal products against COVID-19 needed urgent approval. However, inspectors had to take into account travel restrictions (many of the production sites are located outside the European Union). The inspectors also had to at least observe the restrictions imposed by the health and public safety measures. These situations also led to new inspection methods, both at the Belgian and European level: such as remote inspections of companies by means of tele- and videoconference, inspections based solely on delivered documents, and on-site inspections with colleagues from non-European competent authorities and with remote European inspectors. In other words, hybrid inspections, combining physical and remote inspections, were conducted on a large scale.
These new working methods put a lot of pressure on the teams because the procedures were not yet established at the onset. They were introduced as and when needed and without prior specific training. Remote inspections were time-consuming. The situation led to the development of new procedures, which will continue to be useful for specific cases and will facilitate cooperation between the competent authorities.
One of the benefits of this stressful time is that the expertise of our agency’s inspectors has been highlighted at the international level. This made it possible to develop relations based on mutual trust with authorities outside the European Union, including the competent authorities of the United States and Canada.
In 2021, no inspections were carried out on the advertising of medicines due to the excessive workload of the inspectors in charge of reviewing good distribution practices in the fight against COVID-19. Priority was given to mandatory inspections of good distribution practices.
In 2021, the FAMHP did not receive any complaints or reports of problems related to this topic. No pharmacovigilance investigations were therefore needed.
In 2021, thematic inspections were launched for good distribution practices for blood and human body material.
Unannounced thematic inspections of wholesaler-distributors of medicinal products for human use that focus on the obligations of the wholesaler-distributor regarding:
These inspections are carried out to ensure the quality and safety of blood collection and to check whether the legal requirements are met in the mobile collection operations organised by the blood establishments (collection of blood and blood components in mobile units).
These inspections are carried out in order to check whether the legal requirements are met and whether the quality and safety standards are guaranteed in the depots of registered human body material banks.
A depot is a subdivision of a human body material bank located in a hospital, where a stock of released human body material is stored for human application inside that same hospital.
In 2021, there were 68 % more inspections of good distribution practices compared to 2020.
Due to the COVID-19 health crisis, there were fewer inspections of advertising and other promotional activities. Conferences were only organised virtually or they were postponed.
Due to the impact of the COVID-19 health crisis, the Distribution Division started remote (online) inspections in 2020. This practice was partially maintained in 2021 but on-site inspections resumed for pharmacovigilance, good distribution practices, advertising, blood and human body material.
The Distribution Division was given additional tasks in 2021 due to the COVID-19 health crisis.
Reinspections are only carried out on retail pharmacies who fail to follow the corrective and preventive measures (CAPAs) of a previous inspection. Pharmacists first receive a warning before a reinspection is carried out. There were no such cases in 2021.
An increase in questions from citizens about the dispensing of medicines or about a retail pharmacy. The questions were received directly via the FAMHP generic e-mail boxes or via the call centres of other authorities such as the RIZIV-INAMI (national institute for health and disability insurance) and the FPS Public Health.
In 2021, only questions and surveys were subject to a follow-up. No routine inspections were carried out.
Adjustment of the inspection method due to the stricter requirements set out in Regulation (EU) 2017/245 on medical devices. For example, the requirements for importers and distributors are now set at European level and the requirements for manufacturers (including quality system requirements and technical files) are described in much more detail.
The number of investigations has increased significantly: from an average of 120 investigations per year to 562 in 2021.
The number of inspections into good clinical practices and the number of hospital inspections has decreased due to the COVID-19 health crisis, so as not to place an even greater burden on hospitals.
These parcels contained non-compliant medicines, medical devices and in-vitro diagnostics.
Customs, the Federal Police, the FAMHP and the Federal Agency for the Safety of the Food Chain participated in operation SHIELD II, against doping, counterfeit medicines and abuse of medicines. This operation ran from 1 April to 15 October 2021 and was coordinated by Europol. The Pharma and Food Crime Platform, a partnership involving all stakeholders in charge of fighting food and pharmaceutical crime, also took part in this operation. During this operation, the Belgian authorities seized 87 241 tablets and 99 549 ampoules.
In 2021, the Special Investigation Unit gave more advice as a centre of expertise to external partners. This will lead to a broader and more intensive cooperation with other domestic and foreign inspection services and authorities such as customs, the police and the Department of Justice.
No counterfeit or non-compliant vaccines against COVID-19 were ever found in postal consignments.
At the beginning of the COVID-19 crisis in particular, the service was heavily impacted by the importation of illegal and/or non-compliant surgical masks. These cases were handled in close cooperation with the Medical Devices Division of the DG Inspection.
In 2021, there was a decrease in the number of postal items that were seized as a result of a more specific risk-based selection system applied by customs. The system was initiated in close cooperation between custom and the Special Investigation Unit and is continuously optimised to ensure a more efficient long-term follow-up of parcels sent by post.
Many of the products seized were presented as COVID-19-related medicines: antibiotics, (Chinese) over-the-counter medicines and especially counterfeit ivermectin, a medicine that is authorised within the European Union as a treatment for certain parasitic infections. Also, the import, distribution and sale of non-compliant COVID-19 self-tests became a common phenomenon in the investigations conducted in 2021.