Research involving a clinical trial with an investigational medicinal product (IMP) in an interventional study, falls under the EU Directive for clinical trials (2001/20/EU) and is subject to the UK regulations; The Medicines for Human Use (Clinical trials) Regulations 2004.
In the UK, the regulatory agency for these regulations is called the MHRA: Medicines and Healthcare products Regulatory Agency, which is an executive agency for the Department of Health with trading fund status. The MHRA is also referred to as the Competent Authority (CA). The MHRA is the only authority in the UK that can authorise clinical trials which fall under this EU directive. The EU clinical trials directive regulates the conduct of clinical trials involving medicines for human use. The aims of the directive are:
- To protect the rights, safety and well-being of trial participants
- To simplify and harmonise the administrative provisions governing clinical trials
- To establish a transparent procedure that will harmonise trial conduct in the EU and ensure the credibility of results
Summary of procedures for interventional clinical trials for medicinal products in humans
- Step 1: Does your trial fall under the regulations?
- Step 2: Prepare essential documents for the conduct of the trial
- Step 3: Apply for Clinical Trial Authorisation (CTA) and ethics opinion as well as R&D approval
- Step 4: Perform study in accordance with GCP
- Step 5: Declaration of the end of study
- Step 6: Submit final reports
- Step 7: Ensure essential documents are maintained and archived
Please refer to the Clinical Trials algorithm to establish whether your study is a Clinical Trial of an Investigational Medicinal Product (CTIMP) which falls under the EU directive.
Further guidance is available here