Europe – EudraLex – Clinical trials guidelines – Volume 10

Volume 10 of the publication "The rules governing medicinal products in the European Union" contains guidance documents applying to clinical trials.

A number of documents in Volume 10 are being revised and updated to bring them in line with the changes required by the Clinical Trials Regulation (EU) No 536/2014. Additionally, new documents were prepared to cover new aspects introduced by the same Regulation.

In order to make a distinction between documents applicable to clinical trials authorised under Directive 2001/20/EC (i.e. the current applicable documents) and documents relevant to clinical trials authorised under Regulation (EU) No 536/2014, these documents will be listed in two separate pages on the Eudralex Volume 10 website.

Until the Clinical Trials Regulation becomes applicable sponsors should follow the documents relevant to the Clinical Trials Directive.

During the transitional period, which will last for a period of 3 years starting from when the Regulation becomes applicable, both sets of documents will apply accordingly and should be referred to respectively according to the legislation under which the Clinical trial is conducted.

At the end of the transitional period all clinical trials shall be conducted under the Regulation and should follow only the set of documents applicable to the Regulation.

Although it is not mandatory, stakeholders are encouraged to take already into consideration a number of aspects that are outlined in the new or updated documents published in the page dedicated to the Clinical Trial Regulation and apply them to those clinical trials authorised under the Directive, to the extent possible and in compatibility with the legal framework of the Directive…