The role of the FAMHP

Within Europe, Belgium is among the countries that conduct the most clinical trials per capita. Belgium's network of academic research centres and university hospitals, and the pharmaceutical industry have scientific expertise unlike anywhere else. The competent authorities work continuously with healthcare professionals to support and further develop this leading position in Europe.

As the competent authority for medicinal products, the FAMHP supports innovation and development both in the academic sector and in the pharmaceutical industry in Belgium. This allows patients to have access to new medicines more quickly. Experts at the FAMHP evaluate the quality and safety of experimental drugs used in clinical trials. The FAMHP guarantees you appropriate protection during your participation in a clinical trial.

In collaboration with the ethics committees, the FAMHP verifies whether adequate protection is provided by the sponsor to each clinical trial participant.

Before a trial can be initiated, it must be evaluated by the FAGG and the assigned ethical committee. Together, they ensure the protection of participants in clinical trials and guarantee that the clinical trial is conducted in an ethical and fair manner. Based on their evaluations, the minister or his delegate decides whether or not the clinical trial is approved.

The FAMHP is also responsible for inspection of the clinical trial throughout the process and ensuring compliance with good clinical practice.




Last updated on 22/05/2024