The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK's regulatory body responsible for ensuring that medicines, medical devices, and healthcare products are safe and effective for use by patients. Established in 2003, the MHRA is an executive agency of the Department of Health and Social Care and works closely with other regulatory bodies such as the European Medicines Agency (EMA) and the US Federal Drug Administration (FDA).
The MHRA has a wide range of responsibilities, ranging from the licensing of new products and the monitoring of their safety and quality to the investigation of potential hazards and consumer complaints. Their work also involves the regulation of clinical trials and the enforcement of legislation related to medicines and healthcare products.
One of the key focus areas of the MHRA is pharmacovigilance, which involves the monitoring and reporting of adverse drug reactions and other safety information related to medicinal products. The agency has a sophisticated reporting system, called the Yellow Card Scheme, that allows healthcare professionals and patients to report any suspected side effects or safety concerns related to medicines.
The MHRA also provides guidance and support for companies seeking to develop new medicines or medical devices. This includes advice on regulatory requirements, clinical trial design, and submission of marketing authorization applications. The agency also collaborates with industry organizations and academic institutions to promote research and innovation in the field of healthcare.
In addition to its regulatory functions, the MHRA has an important role to play in public health education and communication. The agency provides information and guidance to the public on the safe use of medicines and healthcare products, and works to raise awareness of issues such as antimicrobial resistance and counterfeit medicines.
Overall, the MHRA plays a critical role in ensuring that the UK's healthcare system operates safely, effectively, and in the best interests of patients. By providing robust regulation, guidance, and support for the pharmaceutical industry, the MHRA helps to promote innovation and access to new treatments while also safeguarding public health.
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