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Clinical trials

Prove efficacy. Demonstrate safety.

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Clinical trials are an essential part of the development and licensing of medicinal products. They are intended to prove the efficacy of new medicinal products and to demonstrate their safety. Clinical trials are performed before the product concerned is placed on the market. Since 2004, they have to be approved in Germany by the respective competent federal higher authority (depending on the type of product, either the BfArM or the PEI). This approval is required in addition to the favourable opinion from the competent Ethics Committee.

However, after the medicinal product has been granted a marketing authorisation, clinical trials also provide important findings on long-term effects of treatments or data on off-label use.

CTIS

Clinical Trials Information System - CTIS

Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC will alter many aspects of the authorisation procedure of clinical trials on medicinal products. With the entry into force of the EU regulation since 31. January 2022, the transition period of 3 years begins. From now on, you have the possibility to submit your data via CTIS.

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News

Clinical Trials Information System – CTIS

Date: 2023.11.02 Topics: Licensing

Message to sponsors transitioning clinical trials from CTD to CTR/CTIS: Clinical trials (CTs) authorised under the Clinical Trials Directive 2001/20/EC (CTD) likely to be ongoing beyond 30 January 2025 need to be transitioned to the Clinical Trials Regulation 536/214 (CTR).

EudraCT-Version 10.5.0.0

Date: 2021.06.17 Topics: Licensing

The EudraCT PUBLIC applications for creating the Clinical Trial Application Form (Annex 1 pdf and xml) have been upgraded to v10.5.0.0. The upgraded version should allow a more user friendly completion of the form.

BfArM's recommendations regarding clinical trials with medicinal products where sponsor or legal representative are established in the United Kingdom (Current note/update from 2019.02.18)

Date: 2019.02.18 Topics: Licensing

For clinical trials in which there is no sponsor or representative of the sponsor who is domiciled in a Member State of the EU or in the EEA at the time when a so-called hard Brexit becomes effective, revocation or suspension of the con-duct of the trial is mandatory by law. Such clinical trials may then not be continued.

More news in the topic Clinical Trials

FAQ

Frequently Asked Questions - Clinical trials

Clinical Trials during the COVID-19 PandemicCOVID-19 Pandemic

Information on the authorisation and conduct of clinical trials of medicinal products during the COVID-19 pandemic.

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Compassionate Use

"Compassionate Use" was introduced into the German legislation with the 14th amendment of the German Medicinal Product Act (AMG) and modified by the amendment of the German Medicinal Product Act in July 2009.

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GCP Inspections Unit

The GCP Inspections Unit is responsible for questions regarding compliance with the regulatory requirements of clinical trials in procedures of the BfArM and procedures of the European Medicines Agency (EMA).

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Statistics

Statistic: Number of clinical trilas applications 2017-2022.

Contact Persons

Contact details for information on clinical trials can be found here.

To the contact persons