All information on the technical requirements for the submission of applications* for clinical trials for medicinal products is described here:
* These include:
- Clinical trials with medicinal products
- Clinical trials with ATMP (Advanced Therapy Medicinal Products, such as transplant products, gene therapeutics, somatic cell therapeutics, products with genetically modified organisms, among others)
- Complex clinical trials
- Applications for a temporary authorisation for the use of medicinal products in accordance with Article 9b paragraph 1 TPA
- As well as all submissions during the conduct of the trials such as
- Changes
- Notifications
- Reports including suspected unexpected serious adverse reaction (SUSAR)
Last modification 03.05.2022