Paul-Ehrlich-Institut

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Non-In­ter­ven­tion­al Stud­ies

More information on this topic is currently available in German only.

The Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut (PEI) have issued recommendations, forms and instructions on planning, implementing and submitting notifications for non-interventional studies (NIS). The PEI provides information on non-interventional studies for which a notification has been submitted in the NIS database (AWB Database in German).

NIS database

Definition

An NIS is a study designed to gather insights into the use of authorised or registered medicinal products. These studies are a sub-group of non-interventional trials within the meaning of section 4 paragraph 23 sentence 3 of the Medicinal Products Act (Arzneimittelgesetz, AMG). Non-interventional trials are defined as studies, in the context of which findings resulting from individuals' treatment with medicinal products are analysed using epidemiological methods; the treatment, including the diagnosis and monitoring, does not follow a predetermined trial protocol but results exclusively from current medical practice. If a medicinal product is used that requires marketing authorisation or approval pursuant to section 21a (1) of the Medicinal Products Act (AMG), the treatment shall be carried out according to the specifications regarding its use contained in the marketing authorisation or approval.

NIS are not subject to approval. Pursuant to section 67 (6) of the AMG, however, the party conducting the study is subject to notification and communication obligations vis-à-vis the competent higher federal authority. Pursuant to section 67 (6) sentence 10 of the AMG, the competent higher federal authority shall make any notifications and final reports received available to the public on the internet.

Updated: 15.12.2022