13.1 A non-interventional study of a marketed medicine is defined as a study where the medicine is prescribed in the usual manner in accordance with the terms of its marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided by a study protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.
13.2 Companies must publish the summary details and results of non-interventional studies of marketed medicines in a manner consistent with their parallel obligations with respect to clinical trials.
13.3 Non-interventional studies that are prospective in nature and involve the collection of patient data must be conducted for a scientific purpose. They must comply with the following criteria:
Attention is drawn to the EU Guidelines on Pharmacovigilance for Medicinal Products for Human Use.Back to top
This requirement applies to non-interventional studies completed on and after 1 May 2011 with which a UK company has had any involvement. Companies are, however, encouraged to publish details and results of such studies completed prior to that date.
Companies are encouraged to comply with Clause 13.3 for all other types of studies covered by Clause 13.1, including epidemiological studies and registries and other studies that are retrospective in nature. In any case, such studies are subject to Clause 18.7.
The approval and supervision of non-interventional studies are dealt with in Clause 21.2.
Companies must comply with Clause 13.3 in relation to noninterventional studies that are completed on or after 1 July 2008. Companies are encouraged to comply in relation to studies completed prior to that date.