The German Regulatory Authority (BfArM) issued a supplementary guidance March 26th on Clinical trials during the COVID-19 pandemic. This is supplemental guidance to the European Guidance on the Management of Clinical Trials during the COVID-19 pandemic which was issued March 20th. The German supplemental guidance notes:
“As the details of clinical trials are mainly regulated by individual provisions of the Member States, this European guidance document cannot recommend a harmonised procedure for all issues. Therefore, after consultation with the Land authorities and in cooperation with the German Association of Medical Ethics Committees, the federal higher authorities have issued a paper on monitoring and the potential shipment of investigational medicinal products.
Although the guideline consists of harmonised recommendations at EU level, which is co-developed and fully supported by Germany, there are specific national laws and guidelines in many EU member states, including Germany, regarding certain topics in clinical trials that must be taken into account and may take precedence over the European recommendations. Therefore, such areas require closer consideration and interpretation. These topics include, in particular, temporarily applicable measures for source data verification, if on-site monitoring at trial sites is not indicated owing to the COVID-19 (coronavirus) pandemic, and the shipment of investigational medicinal product (IMP) to the trial subject, in case IMP distribution to the trial subject at the trial site is not possible.”