Since the start of the coronavirus pandemic, the FAMHP teams have devoted a lot of resources to monitoring and supporting clinical research on COVID-19. Here is an overview of the measures implemented by the FAMHP.
The FAMHP contributes to the fight against COVID-19 by supporting sponsors of clinical trials (medicinal products, vaccines, etc.) and clinical investigations (medical devices) in order to facilitate the research and development of medicinal products and vaccines.
Assistance and guidance with clinical research
Since March, our experts have been working with several institutions and research centres to quickly publish national guidelines to supplement the European guidelines for the management of clinical trials during the coronavirus pandemic. The FAMHP has, for example, committed to validating and reviewing clinical trial applications within four working days.
The FAMHP has also published another national directive on clinical investigations in addition to that concerning clinical trials in the context of the prevention or treatment of COVID-19 and other ongoing clinical studies in Belgium.
18 approved clinical trials
As of 18 June 2020, the FAMHP had already approved 18 clinical trials and 11 amendments, which potentially represents 3,000 patients who can be recruited from 31 different sites.
The FAMHP has, amongst other things, authorised the first clinical trial evaluating a vaccine against COVID-19 in Belgium. This vaccine is the candidate of the German biotechnology company CureVac.
The list of approved clinical trials is available via the clinical trials database on the FAMHP website.
Accelerated scientific opinion procedures
FAMHP experts have also introduced accelerated procedures for scientific and regulatory opinions at national level. These procedures allow academic centres, biotechnology companies and medium/large companies to consult the FAMHP to support and accelerate the development of their products and make them available to patients as quickly as possible.
European collaboration
The FAMHP also contributes to various scientific opinions at European level via the European Medicines Agency (EMA). As such, the FAMHP is very active in an EU Innovation Offices Network (EU IN) European pilot project, which offers a new approach to target the acceleration of the (non-)clinical development of innovative products and treatments against COVID-19.
Keeping an eye on global research
The FAMHP also closely monitors what is happening at European level, in particular within theEmergency Task Force (ETF) set up by the EMA, as well as internationally with the Food and Drug Administration (FDA) in the United States, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO).
In collaboration with the national working group on treatments, the FAMHP is trying to monitor the various results of clinical trials in progress around the world and is collaborating with the national scientific committee and Sciensano to develop a national directive on the treatment of hospitalised patients. This directive has been updated several times as knowledge of COVID-19 changes.
Research progress in figures
|
|
Planned submission |
Submitted |
|
Clinical trials |
38 |
29, of which 18 approved
|
|
National technical and scientific opinions
|
7 |
10 |
|
European technical and scientific opinions
|
- |
3 |
More information
You can find all information from the FAMHP concerning the measures taken during COVID-19 on our website.