Navigating the maze of requirements for obtaining approval of non-interventional studies (NIS) in the European Union.

CONCLUSIONS: The process of obtaining approval for multicentre and multinational NIS is time consuming due to lack of transparency and the different regulatory requirements among member states. The EU pharmacovigilance legislation and clinical trial regulation No 536/2014 is a step forward in providing a regulatory framework for PASS (post-authorisation safety studies) and low intervention clinical trials, but since regulation No 536/2014 excludes NIS, it will be difficult to enforce harmonization of requirements for approval of NIS among member states. PMID: 26633964 [PubMed - in process]
Source: GMS German Medical Science - Category: Journals (General) Tags: Ger Med Sci Source Type: research