Before a clinical trial begins, it must be entered into the Clinical Trials Information System (CTIS), the EU database for clinical trials operated by the European Medicines Agency (EMA). All relevant information on clinical trials is recorded there in order to ensure a sufficient degree of transparency. A large portion of the database is accessible to the public. Details on the EU database can be found in particular in Article 81 of Regulation (EU) 536/2014.

"Start of a clinical trial" means the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol (Article 2 (2) (25) of Regulation (EU) 536/2014). This act can be, for example, the opening of the first study site or the first publication of a study-specific advertisement to attract study participants.

The sponsor informs each participating Member State via CTIS within 15 days of the start of the clinical trial in the Member State concerned. This means that multiple notifications are required in the case of a multinational clinical trial. The sponsor must also inform each participating Member State via CTIS within 15 days of the first visit of the first subject in the Member State concerned (Article 36 (1) and (2) of Regulation (EU) 536/2014).

Once the recruitment of study participants in a Member State has been completed in a regular manner, i.e. as originally planned, the sponsor will inform all participating Member States via CTIS within 15 days. This notification must also be made for the end of recruitment in each of the participating Member States (Article 36 (3) of Regulation (EU) 536/2014). If the recruitment of study participants is to be restarted – for example, after a temporary halt or after a notification has been submitted for the end of the recruitment – and this has no potential effect on the benefit-risk ratio of the study, the sponsor must inform all participating Member States via CTIS in the manner described above.

If the recruitment has been interrupted for safety reasons – due to effects on the benefit-risk ratio – Article 38 Regulation (EU) 536/2014 applies.

If a clinical trial is terminated, the sponsor must inform each Member State concerned of the end of the clinical trial via CTIS pursuant to Article 37 of Regulation (EU) 536/2014. This applies to:

(1) Termination in individual Member States. This notification shall be made within 15 days of the end of the clinical trial in the Member State concerned.

(2) Termination in all Member States (EU-wide termination). In this case, the notification shall be made within 15 days of the end of the clinical trial in the last of the Member States concerned.

(3) Global termination of the clinical trial. This notification shall be made within 15 days of the end of the clinical trial in the last of the Member States concerned and in all third countries in which the clinical trial was conducted.

Within one year of the end of the clinical trial in all Member States concerned, the sponsor shall submit a summary of the results of the clinical trial to CTIS, irrespective of the result of the clinical trial (Article 37 of Regulation (EU) 536/2014).

Annex IV to Regulation (EU) 536/2014 contains the requirements for the summary of the results of the clinical trial. In addition, a summary must be prepared that is formulated in a way that is understandable to laypersons (Annex V).

If the clinical trial is to be used to obtain a marketing authorisation for an investigational medicinal product, the marketing authorisation applicant for the investigational medicinal product must submit the final study report to CTIS in addition to the summary of the results. This must be done within 30 days from the day the marketing authorisation was granted, the procedure for granting the marketing authorisation was terminated, or the applicant withdrew the application for marketing authorisation. The final study report should be structured in accordance with the "Structure and content of clinical study reports" (CPMP/ICH/137/95) Annex 1 – abbreviated to "ICH E3".

For clinical trials completed before 31 January 2025 and conducted within the framework of Directive 2001/20/EC only, a summary of the final report must be uploaded via the Common European Submission Portal (CESP).

Further Information

Regulation (EU) 536/2014
CESP - Common European Submission Platform
Guideline "Structure and content of clinical study reports" (CPMP/ICH/137/95) Annex 1
Information on the electronic submission of documents in accordance with Directive 2001/20/EC

The legal requirements pursuant to section 42b of the German Medicinal Products Act (Arzneimittelgesetz, AMG) changed on 27 January 2022. This obligation, in accordance with section 42b AMG, applies to pharmaceutical entrepreneurs who place a medicinal product on the market that is subject to the obligation to obtain a marketing authorisation or approval within the scope of the AMG.

Pursuant to subsection 1 sentence 1, only reports on all the results of confirmatory clinical trials to prove efficacy and safety that were carried out exclusively in third countries, i.e. exclusively in countries outside the European Union and the European Economic Area (EEA), must be made available to the competent higher federal authority in accordance with section 67a paragraph 2 AMG.

These reports are to be made available within six months of the granting or modification of the marketing authorisation or approval, if the modification is based on confirmatory clinical trials.

The previously valid section 42 subsection 2 AMG has been repealed. This means there is no obligation for sponsors of clinical trials with authorised medicinal products or medicinal products centrally authorised for placing on the market to submit result reports to the competent higher federal authority.
Furthermore, the previous notification obligation for generic marketing authorisations in connection with bioequivalence studies is no longer applicable.

The content requirements for the reports remain unchanged and are now regulated in section 42b subsection 2 AMG. This change means that all results of the clinical trials must be included in the reports, regardless of whether they are favourable or unfavourable. Subsequent essential modifications to the protocol, interruptions, and terminations of the clinical trial must be included in the report. The result reports are as always to be drawn up pursuant to good clinical practice.

A public notice dated 3 August 2011 calls for electronic report submissions to be submitted via the PharmNet.Bund portal. The report must be uploaded as a PDF file. It is then forwarded to the responsible higher federal authority.

The competent higher federal authority checks the information in the synopsis as well as the attached data and documents. If necessary, additional information can be requested. The result reports on clinical trials are marked with the indication that include data from the pharmaceutical company or sponsor and are published in the Clinical Trials section of the PharmNet.Bund portal.