Applications for clinical trials on medicinal products for the treatment or prevention of COVID-19 are processed within four working days. These shorter deadlines, which have already been used since 25 March 2020, are now officially laid down in a circular.
In the fight against COVID-19, the FAMHP intends to fully support the research and development of treatments and vaccines. This is why deadlines for processing clinical trial applications for medicinal products and vaccines against COVID-19 were significantly shortened. The FAMHP is thus once again ensuring an optimal climate for research and development in Belgium.
Four working days
Clinical trial applications according to the procedure contained in Article 13, § 1 of the Experiments Law 2004 and the procedure for pilot projects contained in Article 34/1, § 1 of the same Law will be processed in four working days. If Article 16 of the same Law is used or if the FAMHP requests additional information, the FAMHP will process the request within four working days following receipt of the additional elements.
For clinical trials involving advanced therapies (somatic-cell therapy medicinal products, tissue-engineered products or gene therapy medicinal products) or medicinal products containing genetically modified organisms (GMOs), a shorter deadline of ten working days shall apply.
Although the fee for processing the applications still needs to be paid, the start of the processing does not depend on the receipt of the payment.