MHRA statement on clinical trial in France
MHRA statement on Phase 1 clinical trial in France
An MHRA spokesperson said,
There is no clinical trial taking place in the UK with this product nor has it been used in a clinical trial in the UK in the past.
Clinical trials in general have an excellent safety record and hundreds of Phase 1 clinical trials are authorised each year by MHRA.
Before any trial of a new medicine begins in humans, the product will have undergone extensive pre-clinical testing, both in the laboratory and in animals as appropriate.
Safeguards for clinical trials are well-established and regulations are in place, which specifies how clinical trials should be conducted.
Background
- Clinical trials in the UK are regulated by The Medicines for Human Use (Clinical Trials) Regulations 2004. Clinical trials of medicines on people requires authorisation by the competent authority (MHRA in the UK) and a favourable opinion from an ethics committee. This authorisation is granted in the form of a clinical trial authorisation (CTA).
- In 2007 following on from the recommendations of an independent Expert Scientific Group which was brought together to examine the design of Phase 1 clinical studies, it was convened by the Secretary of State for Health to look at how to improve the safety of drug trials following adverse reactions experienced by participants in the clinical trial of TGN1412.
- MHRA implemented an accreditation scheme for companies running Phase I clinical trials in the UK. This scheme is voluntary and aims to make sure trials are as safe as possible and to create public confidence in the regulation of these trials. * Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies. See guidance on the phase 1 accreditation scheme for more information * In the UK all Phase 1 clinical trials need be have been authorised by MHRA
- MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.
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