Coronavirus: updated timelines for applications for COVID-19 clinical trials
November 22, 2021
Since 25 March 2020, shortened deadlines have been used for applications for clinical trials with medicinal products for the treatment or prevention of COVID-19. As the vaccination campaign has reached the majority of the population, these reduced timelines are now extended to 15 calendar days.
Source: FAMHP
Applications will be processed in fifteen calendar days for clinical trials:
- that follow the normal procedure, described in Article 13, § 1 of the Law of 7 May 2004 on experiments on the human person (further: Experiments law);
- that follow the procedure for pilot projects, described in Article 34/1, § 1 of the Experiments law;
- with advanced therapies (somatic cell therapy medicinal products, tissue engineered products or gene therapy medicinal products), described in Article 17 of the Experiments law;
- for medicinal products containing genetically modified organisms (GMOs), described in Article 17 of the Experiments law.