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Ethics Committee; application for registration

If you want to assess clinical trials of medicinal products as a public ethics committee, you must first register with the Federal Institute for Drugs and Medical Devices (BfArM).

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Bundesinstitut für Arzneimittel und Medizinprodukte

Street address

Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Postal address

Kurt-Georg-Kiesinger-Allee 3

53175 Bonn

Website

www.bfarm.de

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Procedure details

Clinical trials of medicinal products are intended to prove the efficacy of new medicinal products and to determine their safety and tolerability. An important part of the approval process for such clinical trials is an ethical review by ethics committees.

As a public-law ethics committee of a federal state, you must register in order to participate in the procedure for evaluating an application for approval of a clinical trial.

As the responsible body of the ethics committee, you must submit the registration application to the Federal Institute for Drugs and Medical Devices (BfArM). The BfArM decides on the application in agreement with the Paul-Ehrlich-Institut (PEI).

  • required up-to-date scientific expertise of the members of the Ethics Committee and the external experts
  • interdisciplinary composition of the Ethics Committee with the participation of
    • at least one lawyer in each case
    • one person with scientific or professional experience in the field of ethics in medicine
    • one person with experience in the field of experimental design and statistics
    • 3 doctors with experience in clinical medicine,
      • one of whom is a specialist in clinical pharmacology or pharmacology and toxicology
    • one layperson
  • the Ethics Committee has both female and male members and women and men are equally considered in the selection of members and external experts with the aim of equal participation
  • rules of procedure which, in particular, lay down binding rules on the working methods of the Ethics Committee; these include, in particular, rules on management, chairmanship, the preparation of resolutions, the passing of resolutions and the honorary nature and duty of confidentiality of members and external experts:
    • an office with the qualified staff required to organize the tasks of the Ethics Committee
    • equipment that enables voting procedures to be carried out at short notice and opinions and assessment reports to be prepared on time
  • the Ethics Committee obtains declarations of independence for each application from the members and external experts involved, stating that they have no financial or personal interests that could affect their impartiality
  • Application for registration must contain information on whether the Ethics Committee is registered with the Federal Office for Radiation Protection in accordance with radiation protection legislation

  • Required Documents
    • Geschäftsordnung der Ethik-Kommission

You can submit the application electronically. Proceed as follows.

  • First send an e-mail to Registrierung-EK@bfarm.de
  • You will receive a personalized link that you can use to access the application documents.
  • Fill out the form.
  • Upload all the required documents.
  • Send the application electronically.
  • You will receive a notification in text form by e-mail that your registration application has been received.
  • The BfArM will review your application and make a decision in consultation with the PEI.
  • You will receive a notification of the decision in text form by e-mail.
  • If the application is successful, your ethics committee will be included in the list of registered ethics committees participating in the procedure for assessing an application for approval of a clinical trial in the Federal Gazette.

You can submit the application free of charge.

You must register before participating in the process of evaluating an application for approval of a clinical trial.

You must also notify us immediately of any changes to your registration.

Processing usually takes between 1 and 3 months.

  • Objection.
  • Appeal.
    Detailed information on how to lodge an appeal can be found in the notification of your application.
  • Administrative court action

Status: 09.03.2025
Editorially responsible for prodecure description: Bundesministerium für Gesundheit
Source: Federal Portal
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