Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA, or Medicines and Healthcare products Regulatory Agency, is an essential part of the United Kingdom’s Department of Health. Founded in 2003, the agency is responsible for . MHRA is involved in the protection and maintaining public health, supporting the development and innovation in this field. The agency manages both the CPRD (Clinical Practice Research Datalink) and the NIBSC (National Institute for Biological Standards and Control). The London-headquartered agency employs over 1,200 individuals across England.

Three main centres of the MHRA:

• CPRD provides a data research service that intends to make public health better by utilising NHS clinical information (anonymised).

• The NIBSC is engaged in the standardisation and management of biologics (biological medicines).

• MHRA is the regulator for the pharmaceutical and medical devices industries. Regulates medicines, medical devices, and blood components for transfusion, responsible for safeguarding their safety, quality, and efficacy in the UK.

What is the role of the MHRA in clinical studies?

Medicines and Healthcare products Regulatory Agency (MHRA) plays a vital role in the drug development process. For a clinical trial for a new drug to commence, it must first be assessed and authorised by the MHRA.

The agency examines sites where the clinical trials are conducted to ensure they are carried out in accordance with good clinical practice.

The clinical trials are designed to demonstrate the effect of new medicines as per the anticipations. The results from the clinical trials are sent to the MHRA. After the assessment of the clinical trial results, the agency decides whether to allow the sponsor or healthcare company manufacturing the medicine to market it for a particular indication


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