December 2022: Germany Regulatory Update

An announcement was published on December 15, 2022, on the BfArM website regarding the notification of observational studies according to section 67 para. 6 of the Medicine Act (AMG) and on the non-interventional safety studies according to section 63f AMG.

As per the section 67 and section 63 of AMG regulation, there is an obligation to report the post-marketing observations and non-interventional safety studies (PASS) to the competent higher federal authority without delay. The German Medicine Act has increased the scope of reporting non-interventional safety studies, now the obligation to notify is not limited to studies that prospectively collect primary data, but also includes registers, retrospective studies, secondary data analysis and cross-sectional studies.

Safety studies that were started by October 26, 2012 are to be classified as observational studies and would continue to fall under the regulations of Section 67 Paragraph 6 AMG with regard to the notification and transparency obligations.

More information on this announcement can be found here.