Clinical Trial Regulation: European Medicines Agency
The implementation of the new European Union (EU) Clinical Trial Regulation will provide a unified portal and database for trial sponsors and regulatory agencies across the EU Member States, promising to bring greater regulatory convergence and efficiency to the clinical trial application process.
Clinical trials are at the core of the pharmaceutical research and development (R&D) process. The results of these studies inform decision-making on market approval, medicines pricing and reimbursement, and clinical practice. Clinical trial transparency is therefore extremely important for policy makers, public health bodies, the research community, healthcare professionals and patients. Nevertheless, important information on clinical trials remains hidden from public and scientific scrutiny, even where research is publicly funded.
The new Clinical Trial Regulation (CTR) is set to revolutionize the clinical trial processes across Europe, impacting all European Union (EU) member states and companies that wish to run clinical trials across the region. It is applicable for Investigational Medicinal Products (IMP) for human use and does not apply to non-interventional trials or trials without medicinal products such as devices, surgery, etc. Clinical trials will be assigned with a unique EU trial number and the relevant data and information will be accessible to the public with the exception of personal data, commercially confidential information, confidential communication belonging to the EU Member States or data ensuring the effective supervision of the conduct of the clinical trial.
The regulation seeks to provide a single, unified portal and database for both trial sponsors and regulatory agencies in each member state. For sponsors, the portal will be the main platform to submit applications and notifications allowing regulators to conduct their assessments and supervise the trial. Moreover, annual reporting of clinical trials involving the use of more than one investigational medicinal product is simplified by submitting a single safety report on all the investigational medicinal products used in the clinical trial.
Safety reporting by the investigators is not required if the adverse event is envisaged in the study protocol. Sponsors conducting clinical trials outside the EU but intending to submit an application for a marketing authorisation within the EU must conduct those clinical trials by following principles equivalent to the EU legislation.
The Clinical Trials Regulation will introduce rules that will greatly facilitate conduct of clinical trials to stimulate clinical research. There is a need for sponsors to align their respective internal procedure with the new requirements to ensure a successful transition to the new regulatory system.
✔️Streamlining the process for clinical trial application across the EU
✔️Assessing and authorizing clinical trials by removing duplication and reducing delays in the process
✔️Introducing a lighter regulatory regime for trials conducted with medicines that are already authorized and which pose minimal risk compared to normal clinical practice
✔️Simplifying reporting requirements, sparing researchers from submitting largely identical information on the trial process to various bodies
✔️Recognizing co-sponsorship, which acknowledges that a trial can be led by more than one organization
✔️Introducing the concept of a single decision on a clinical trial, which will replace the previous separate approvals given by the National Competent Authorities and Ethics (NCAE) committees and reduce the administrative burden on the Member States Concerned (MSC)