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FAQ - Clinical Trials

Here you will find all frequently asked questions (FAQ) listed in the section Drugs – Before Authorisation – Clinical Trials.
If you click on a subject from the list below you will be linked to the corresponding questions and answers.

General questions and answers

• Authorisation procedure for clinical trials
• Demarcation issues
• Application form
• Notification obligation pursuant to Section 67 of the German Medicines Act
• Subsequent amendment
• Trial interruption, discontinuation of recruitment, trial termination
• End of a clinical trial
• Costs in connection with clinical trials
• Submission procedure for clinical trials

Questions and answers with regard to pharmaceutical quality

• Labelling
• Manufacturing authorisation/import authorisation
• Documentation of quality and manufacture
• Active Substance Master Files (ASMF)

Questions and answers with regard to clinical issues

• Formal aspects regarding clinical issues (special aspects)
• Trial protocol
• non-interventional studies ("Anwendungsbeobachtungen")
• Paediatric studies
• Final clinical trial reports
• Annual safety reports
• Reporting of SUSARs

Questions and answers with regard to preclinical/toxicological issues

• Formal aspects regarding pharmacological/toxicological issues (special aspects)
• Licensed medicinal products
• Unlicensed medicinal products