BfArM - Federal Institute for Drugs and Medical Devices

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Why should a study be registered with the DRKS? Date: 28. October 2021 Topics: About BfArM Type: FAQ

The DRKS is the only study registry for Germany recognised by the WHO and collects study data in German and English. Patients and other interested laypersons can better use and understand entries in their national language. Information provided in …

What are the objectives of the DRKS? Date: 28. October 2021 Topics: About BfArM Type: FAQ

The goals of the DRKS can be found in our "About Us" section.

When should clinical trials be registered? Date: 28. October 2021 Topics: About BfArM Type: FAQ

In order to register a trial according to ICMJE standards, it has to be registered in a registry accepted by the ICMJE before recruiting the first participant (=prospective registration). A participant is considered as recruited as soon as the …

Does the DRKS meet ICMJE criteria? Date: 28. October 2021 Topics: About BfArM Type: FAQ

Yes. The ICMJE accepts registration in all primary registries and data provider registries of the WHO network. The DRKS has been recognised by the WHO as a primary register for Germany since October 2008 and thus fulfils the requirements of the ICMJE

Can a study once registered in the DRKS be deleted from the register? Date: 28. October 2021 Topics: About BfArM Type: FAQ

No. The DRKS is the primary registry for Germany recognised by the WHO and is bound by the WHO's international standards for clinical trial registries. It stipulates in section 1.5 that once a study has been registered, it may never be deleted.

WHO

Locations of the Federal Institute for Drugs and Medical Devices Date: 13. July 2021 Topics: About BfArM Type: Article

Locations of the Federal Institute for Drugs and Medical Devices

#bfarmDigitalFuture PDF, 6MB, File is accessible Date: 10. March 2021 Topics: About BfArM Type: Download

Shaping health together: The BfArM as a partner in Germany and Europe.

Digital Future Date: 19. February 2021 Topics: About BfArM Type: Article

Shaping health together: The BfArM as a partner in Germany and Europe.

History Date: 25. May 2020 Topics: About BfArM Type: Article

AMG-Kostenverordnung englische Fassung PDF, 206KB, File is accessible Date: 20. May 2020 Topics: About BfArM Type: Download

Ordinance Regulating the Fees Payable for Marketing Authorisations granted by the Federal Institute for Drugs and Medical Devices and/or the Federal Office of Consumer Protection and Food Safety (AMG Fees Ordinance – AMGKostV)

Tasks Date: 20. May 2020 Topics: About BfArM Type: Article

Tasks

Tasks Date: 20. May 2020 Topics: About BfArM Type: Article

Tasks

Library of the Federal Institute for Drugs and Medical Devices Date: 21. March 2019 Topics: About BfArM Type: Article

Library of the Federal Institute for Drugs and Medical Devices

Annual report 2017/18 PDF, 1MB, File does not meet accessibility standards Date: 23. August 2018 Topics: About BfArM Type: Download

Annual report 2017/18

Where in the notice on fees and expenses can I find the data relevant for allocation of the subject notice (e.g. notice of marketing authorisation/renewal etc.)? Date: 26. October 2017 Topics: About BfArM Type: FAQ

Since the BfArM is an institution within the portfolio of the Ministry of Health, it has to fulfil the tasks assigned by the legislator with regard to budgetary and financial affairs. These tasks are carried out as instructed by the Ministry of …

Manual - only available in German PDF, 423KB, File is accessible Date: 10. July 2017 Topics: About BfArM Type: Download

Joint Advice through the BfArM or PEI and the Federal Joint Committee (G-BA)

Annual report 2014/15 PDF, 6MB, File does not meet accessibility standards Date: 30. May 2016 Topics: About BfArM Type: Download

Annual report 2012/13

Contact persons Date: 30. January 2016 Topics: About BfArM Type: Article

Contact persons

Annual report 2012/13 PDF, 9MB, File does not meet accessibility standards Date: 30. April 2014 Topics: About BfArM Type: Download

Annual report 2012/13

What does the term "the party liable for fees" mean? Date: 10. March 2014 Topics: About BfArM Type: FAQ

For claims that arose before the Federal Fees Act (Bundesgebührengesetz) came into effect on 15 August 2013, the term "party liable for costs" applies in the sense of Section 13 of the Administrative Costs Act (Verwaltungskostengesetz). …

When is a claim due? Date: 10. March 2014 Topics: About BfArM Type: FAQ

Hitherto, costs were strictly due from the party liable for fees upon announcement of the decision on costs, unless the authorities had specified a later point in time (Section 17 of the Administrative Costs Act (Verwaltungskostengesetz) cf.

When must a late payment penalty be paid? Date: 10. March 2014 Topics: About BfArM Type: FAQ

For claims that arose before the Federal Fees Act (Bundesgebührengesetz) came into effect on 15 August 2013, Section 18 of the Administrative Costs Act (Verwaltungskostengesetz) is still valid. According to this, a late payment penalty of one …

Joint Declaration of Intent Swissmedic - BfArM PDF, 31KB, File is accessible Date: 14. February 2014 Topics: About BfArM Type: Download

Declaration of Intent