Here you will find information and assistance for the submission of a clinical study according to the German Medical Product Act (AMG) to one or more ethics committees in Germany.
Ethics committees perform statutory tasks in accordance with the German Medical Products Act and Regulation (EU) No. 536/2014 of the European Parliament and of the Council of April 16, 2014, and to this extent are a public body (authority).
The EU Regulation 536/2014 specifies that the documents to be evaluated are divided into two sections: Part 1 (including protocol and investigator information, benefit-risk assessment; see Article 6) and Part 2 (including requirements for consent; recruitment; suitability of the trial site as well as persons involved in the conduct; data protection; insurance; handling of biomaterials; Article 7). For Germany, it was specified in 2016 that ethics committees provide an assessment for both parts (see § 40 (4) and (5) and § 41 (1) AMG new). The higher federal authority (BOB) assesses all aspects to be evaluated in part 1 and makes the final decision (approval or refusal; see Section 40 (8) AMG new). In doing so, the BOB is bound by the opinion of the Ethics Committee on Part 2. The opinion on Part 1 must be taken into decisive consideration by the BOB; deviations from it must be documented and justified in the BOB’s decision (see § 40 (8) and § 41 (3) AMG new).
Until the date of application of EU (VO) 536/2014, the following applies: Ethics Committee and BOB evaluate and decide independently of each other. The clinical trial may only be carried out if there is a positive evaluation by the Ethics Committee and an approval by the BOB (§ 40 (1) AMG).
The following texts and templates serve the purpose of harmonization and quality assurance. They have been agreed upon in extensive consultations within the AKEK. Their regular application contributes significantly to the acceleration of the entire approval procedure.
Our texts and templates are until now only available in german. We are working hard to provide english translations as soon as possible. Please note that not all texts have yet been adapted to the GDPR.
Joint pilot project of federal higher authorities and ethics committees for the processing of applications for clinical trials with medicinal products for human use in accordance with Regulation (EU) No. 536/2014 while simultaneously taking into account the legal requirements of the German Medical Products Act and the GCP Regulation.