February 2022: Germany Regulatory Update

A notice was published on February 01, 2022, on the BfArM website regarding Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use.

Information in this notice aims to support the harmonization of the application and interpretation of the new regulations on clinical trials by the federal states as they come into force. The BMG and the higher federal authorities BfArM and PEI have provided the following information:

  • Details on the effective date and transitional provisions: As of January 31, 2022, Regulation (EU) No. 536/2014 is applicable. The applications for clinical trial approval can be submitted to the authorities according to the previous law by January 30, 2023, at the latest. Clinical trials started under the previous law can be continued under it until January 31, 2025. Final reports for clinical trials completed under the previous law can still be submitted to the EudraCT database.
  • Details on the application and interpretation of the new law: This provides details for differentiating between clinical trials, clinical studies, and non-interventional studies according to Regulation (EU) No. 536/2014 and the corresponding regulation that will be applicable.
  1.  For studies that are not classified as clinical trials according to Article 2 para 2 No. 1 of Regulation (EU) No. 536/2014, if necessary, a notification as an application observation according to Section 67 para 6 AMG will be required to be submitted to the federal authorities.
  2. If it is a clinical study, it must be checked if it is a trial within the meaning of Article 2 para 2 No. 2 of Regulation (EU) No. 536/2014. If this is not the case, it is a non-interventional study within the meaning of Article 2 para 2 No. 4 of Regulation (EU) No. 536/2014. For non-interventional safety studies within the meaning of Section 63f AMG and for application observations within the meaning of Section 67 (6) AMG, the specifications there apply.
  3. If it is a clinical trial, Regulation (EU) No. 536/2014 applies. If the requirements of Article 2 Paragraph 2 Number 3 of Regulation (EU) No. 536/2014 are met, the clinical trial can be classified as a minimal intervention clinical trial.
  • Additional Clarifications: The application for the approval of a clinical trial in Germany can be submitted via the EU portal according to Article 80 of Regulation (EU) No. 536/2014 in German or English.

Further details of this notice can be found here.