REGULATION NO. 536/2014/EU APPLIES TO CLINICAL TRIALS AS OF JANUARY 31, 2023
EU Regulation No. 536/2014 on clinical trials of medicinal products for human use (Clinical Trial Regulation; hereinafter "CTR Regulation") applies to all clinical trials conducted in the EU as of January 31, 2023. The CTR Regulation, however, does not apply to non-interventional studies.
Applications submitted before the above deadline in accordance with the previous 2001/20/EC Directive will be subject to the provisions of this Directive for a further three years.
The CTR Regulation aims to create more consistent rules and a more straightforward procedure for clinical trial authorization in the Member States by encouraging their participation in the authorization process.
The CTR Regulation accomplishes this goal by establishing a single EU-wide platform for clinical trial authorization under the CTR Regulation. This is known as the EU database (Clinical Trial Information System, CTIS). Because of the single database, it is sufficient to submit a single authorization application that may cover several or even all Member States, eliminating the need to initiate a separate authorization procedure in each Member State. Registration on the portal is required for all applications to be processed. The data managed in the single EU database is publicly accessible, which improves clinical trial data transparency.
Prior scientific and ethical review of clinical trials is required. This includes an assessment report divided into two parts. Part I of the assessment report is completed by the Member State designated as the reporting state from among the Member States concerned. In contrast, Part II is conducted independently by each Member State concerned with its territory.
Under the CTR Regulation, it is also possible to refer to a clinical trial conducted outside the EU in the application dossier submitted for authorization; however, in this case, the clinical trial referred to must comply with specific CTR Regulation rules, such as subject rights and safety, reliability, and robustness of the data obtained in the clinical trial.