Germany

Germany

PharmNet.Bund

Verified on March 3, 2023

Germany has a primary registry, German Clinical Trials Register (DRKS) which has a provision to publish protocol registrations. DRKS is a World Health Organization (WHO) recognized primary registry. In addition, PharmNet.Bund has a requirement to post the results of clinical trials that are conducted outside Germany and the European Economic Area (EEA) i.e., exclusively in third countries. Posting protocol registration in DRKS is voluntary, whereas, it is mandatory to submit study results to PharmNet.Bund, for studies conducted outside of Germany. From January 31, 2022, European Union Clinical Trial Information System (EU CTIS) has become functional, and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EU CTIS Not Applicable Competent authority, Sponsor Clinical Trial Application

Interventional

(Phase 1-4) 		English
EU CTR EU CTR via Clinical Trial Applications Competent authority Clinical Trial Application

Interventional

(Phase 1-4) 		English
German
EU PAS EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) Sponsor Through a dedicated registration platform (process independent from clinical trial application) Post-authorization Safety Efficacy Studies English
PharmNet.Bund Mandatory National Database (includes Ethics Requirement) Sponsor, Marketing authorization holder Sponsor at end of study

Interventional

(Phase 2-4);

Observational

 German
English
BfArM Non-Interventional Studies (NIS) Mandatory National Database (includes Ethics Requirement) Competent authority Sponsor at end of study

Observational

 German
English
Paul Ehrlich Institute (PEI) Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 2-3) 		German
English
German Clinical Trials Registry (DRKS) Academic/Patient Registries/Voluntary Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 0-4);

Observational

 German
English
University Hospital Cologne Academic/Patient Registries/Voluntary Investigator Through a dedicated registration platform (process independent from clinical trial application) All ongoing studies under the hospital English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
EU CTIS Registration

Yes

 Prior to enrollment
Results

Yes

 Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies)
EU CTR Registration

Yes

 Prior to enrollment
Results

Yes

 Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies)
EU PAS Registration

Yes

 Before the start of data collection
Results

Yes

 Within 12 months of end of data collection
PharmNet.Bund Registration

No

 Not applicable (NA)
Results

Yes

 Within 12 months of Study Completion (Authorized Products); Within 6 months of Product Authorization (Unauthorized Products)
BfArM Non-Interventional Studies (NIS) Registration

No

 NA
Results

Yes

 Within 12 months of end of study
PEI Registration

Yes

 Prior to enrollment
Results

Yes

 Within 12 months of Study Completion (Authorized Products); Within 6 months of Product Authorization (Unauthorized Products)
DRKS Registration

No

 Prior to enrollment
Results

No

 NA
University Hospital Cologne Registration

No

 NA
Results

No

 NA

Other Mandatory Requirements

  • A Clinical Trial Application (CTA) is required to be submitted to the national competent authorities (NCA) – Federal Institute for Drugs and Medical Devices (BfArM) or Paul-Ehrlich Institute (PEI) by the sponsor via EudraCT.
  • Results are required to be posted on EudraCT per European Directive 2001/20/EC.
  • Results will now be required to be posted on EU CTIS per Regulation (EU) No 536/2014.

Registry Updates

  • March 2023: CTIS Newsflash - On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
  • March 2023: CTIS Newsflash - On March 03, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
  • February 2023: Clinical Trials Highlights - On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page. Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of … Continue reading "February 2023: Clinical Trials Highlights"

References