The Medicines and Healthcare products Regulatory Agency (MHRA) is an administrative body of the Department of Health and Social Care within the United Kingdom that is responsible for assuring that medical devices and medicines are suitable and are properly approved for use. The MHRA has four main functions; to regulate the manufacture, sale and dispensation of medicines throughout the United Kingdom; to protect the public from the risks of using unsafe medicines; and to ensure that all aspects of the manufacturing process are carried out to the highest safety standards. It is also responsible for regulating the quality of clinical documentation required by healthcare professionals when treating patients.
All medicinal drugs in Great Britain must be approved by the MHRA before they can be sold or provided to anyone who may require them. This regulatory body also takes on the responsibility of ensuring that companies manufacture drugs according to high quality standards and that clinical trials involving new drugs are conducted rigorously. When a company submits an application to the MHRA to be able to market or sell a pharmaceutical product, it must provide complete details about the production process and any regulatory authorities or independent medical experts that have approved the drug. For details on Adaptive Phase 1 Clinical Studies, visit Richmond Pharmacology phase 1 clinical studies
If a manufacturer of a certain type of drug has not complied with these regulations and standards, then it could be deemed illegal and the company could be blacklisted from production. This helps the regulatory authority to carry out its own investigation into the matter and determine whether the drugs are being sold according to acceptable guidelines. If new drugs or treatments for conditions are approved for sale, then the MHRA will then work with the company involved to conduct clinical trials to see if the new drug is suitable for use by patients.