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Clinical trials during the COVID-19 pandemic

Important notice

With the end of the COVID-19 pandemic, this page will no longer be updated. For the latest updates, see update history.

1. General aspects

The numerous consequences arising from the COVID-19 pandemic also have an effect on clinical trials of medicinal products that are already ongoing or planned. The BfArM is in close contact with its European counterparts, the EMA as well as the EU Commission and participated intensively in the compilation of the Commission's recently published European guidance document regarding the management of clinical trials in the current pandemic situation.

Guidance on the management of clinical trials during COVID-19 pandemic (Version 4.0)

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.

Supplementary Recommendations to EU Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic (Version 4.0) PDF, 186KB, File does not meet accessibility standards

The developments in this pandemic are currently very dynamic which can lead to rapid changes in such recommendations. Therefore, applicants and sponsors are requested to watch for revisions of the documents.

Inquiries in connection with new clinical trials related to COVID-19 should be sent to the e-mail address CT-COVID@bfarm.de .

2. Notifications of variation of ongoing clinical trials due to COVID-19

Due to the current situation, notifications of variations necessary due to the pandemic are given utmost priority. Applicants are requested to include a short reference to "COVID-19" in the subject line of their cover letter. If possible, such submissions should be made electronically via the European CESP portal.

3. Clinical trials of medicinal products related to COVID-19

The BfArM treats all applications and requests for advice in direct connection with clinical trials and drug development related to COVID-19 with utmost priority and flexibility. We have installed the special e-mail address CT-COVID@bfarm.de for questions in connection with clinical trials related to COVID-19. Please use this address only for inquiries and not for submission of variation notifications or applications for authorisation. Applications for scientific advise as well as clinical trials on diagnosis, prophylaxis or therapy of COVID-19 are processed free of charge during the COVID-19 pandemic.

4. Safety Reporting in connection with clinical trials related to COVID-19

The regulations in accordance with Sections 12 and 13 GCP-V concerning safety reporting in clinical trials continue to apply during this pandemic. This concerns both the reporting of serious adverse events (SAE) to be reported immediately by the investigator to the sponsor unless the licensed trial protocol provides otherwise, as well as the sponsor's reporting obligations towards federal higher authorities, other authorities, and Ethics Committees. If, in connection with an SAE report, a trial participant is unable to visit the trial centre in person, initial communication with the investigator can also take place by telephone. In such cases, a decision must be made as to whether the participant's appearance in person, e.g. for further testing, is necessary based on safety considerations. If it is intended to convert regular visits in in part or completely to telephone contact or telemedical visits, this is to be submitted to the competent federal higher authority and competent Ethics Committee as a notification of variation subject to approval. In the case of notifications of variation that affect safety reporting, the sponsor is requested to include a risk analysis of the effects of these changes on the safety of trial participants and the validity of the data collected.

5. Discontinuation of patient recruitment

Sponsors of clinical trials are requested to evaluate whether continuation of patient recruitment during the pandemic is reasonable or should be discontinued. Should it become necessary to discontinue recruitment, this will require a notification of variation, but in order to simplify matters, the BfArM does not insist on use of the amendment form for submission. It is also possible to apply for discontinuation of recruitment together for several clinical trials by way of a collective letter. Should you wish to do this by e-mail, please begin the subject line of e-mail and cover letter with the term "COVID-19". Resumption of recruitment will require a renewed variation notification subject to approval with competent federal higher authority and competent Ethics Committee.

Contact data for clinical trials of medicinal products:

E-mail: ct@bfarm.de
E-mail for inquiries concerning clinical trials related to COVID-19: CT-COVID@bfarm.de
Telephone: +49 (0)228 99 307 4318

Update history

  • 30-03-2020: Version 2.0: Link updated to amended version of the European Guidance Document.
  • 30-03-2020: Version 2.1: Reference to fee reduction option, reference to English version
  • 07-04-2020: Version 2.2: Fee exemption for clinical trial applications and scientific advise in the context of COVID-19 trials
  • 28-04-2020: Version 2.3: Link updated to amended version of the European Guidance Document.
  • 19-05-2020: Version 3.0: Update of the supplementary recommendations of BfArM and PEI to the European Guidance on the Management of Clinical Trials during the COVID-19
  • 27.05.2020: Version 3.0a: Linguistic corrections