Clinical trials – according to Directive 2001/20/EC

From January 31, 2025, no clinical trials can be conducted according to EU Directive 2001/20/EC and related national legislation as the EU Regulation 536/2014 (Clinical Trial Regulation, CTR) is fully applicable.

End of trial and results of clinical trials according to Directive 2001/20/EG must be reported.

End of trial

Notify the Swedish MPA at the latest within 90 days from the End of trial. Use the EU‍-‍common form called Declaration of the End of Trial.

The common principles to be followed when notifying an End of trial on this form are in line with Directive 2001/20/EC, Volume 10, Clinical trials guidelines.

In case of a multi-country trial, if the national and global end of trial dates are different in a given Member State, the Sponsor shall submit this form two times:

1. At the end of the trial in the individual Member State, section D1.1 shall be completed and submitted to the respective National Competent Authority.
2. At the global end of the trial, the Sponsor shall complete section D.2.1 with the global trial end date and the completed form shall be submitted to all participating Member States in order to allow the Sponsor to prepare the trial result summary within the 12‍-‍months timeframe (in case of a paediatric study, see section Reporting study results).

If the national and global end dates coincide in a concerned Member State, the form shall be submitted only once to the National Competent Authority of this Member State with both sections D1.1 and D2.1 complete.

For Declaration of the End of Trial Form, see Chapter I, on the EU Commission website.

Reporting study results

Publishing of result-related information in EudraCT database

In line with the commission guideline – Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006 – the Sponsor shall publish the results of a clinical trial in the EudraCT database.

This guideline addresses the posting and publishing of clinical trials as defines in Article 2 (a) of Directive 2001/20/EG.

After the Sponsor has submitted the End of Trial form, the Sponsor must upload the results in the EudraCT database (Full data set) within one year after the end of trial

The time limit for reporting results from a clinical trial on children where the medicinal product is approved and the sponsor of the trial is the marketing authorisation holder of the medicinal product is 6 months. This is stated in Article 46 of EU Regulation 1901/2006.

As the study results are uploaded in the EudraCT database, the Sponsor does not need to send in neither a synopsis nor a study report to the Swedish MPA. However, a final report must be available at the request of the MPA.

Guidance on posting and publication of result-related information, see Chapter V, on the EU Commission website. Technical guidance on the format of the data fields can be found in the same chapter.

When entering data in the EudraCT database some fields of the result-related information on clinical trials will be updated automatically and some are free text fields. For most clinical trials the structure of collected data is appropriate. However, if the necessary information cannot be provided via the data fields, use the comment fields.

Further information on posting study-related information from clinical studies ended before or after the 21 July 2014 respectively can be found on the EMA website.