Regulatory Support for Clinical Trials

Before commencing a clinical trial on a medicinal product in an EU country, an application for Clinical Trial Authorisation (CTA) must be submitted and approved by the corresponding national competent authority. CTAs in the EU must be supported by a common set of data and core principles; however, some Member States may require additional data or have differences of opinion on the adequacy of CTA data.

For more information on Regulatory Support for Clinical Trials talk to PharmaLex UK Services Limited