Medicines and Healthcare Products Regulatory Agency (MHRA)
MHRA or Medicines and Healthcare products Regulatory Agency is a Government run body responsible for ensuring the quality and safety of medicines and medical products. MHRA is a wing of the Department of Health.
The agency regulates the medical devices, equipments and medicines that are employed in the healthcare sectors and also in the harmful incident investigations.
It is also concerned with the regulation of blood supply and blood products and it works with the blood services operating in UK, the healthcare providers and other such related organizations for the improvement of blood quality and safety.
Foundation
MHRA was established by the government in UK in April 2003 after bringing together the Medical Devices Agency and the Medicines Control Agency.
Purpose & Mission
The agency regulates a wide variety of medical products and healthcare drugs and services that have been produced by tissue engineering. For instance, the medicines that are sold in the medical outlets in UK are subjected to stringent scrutiny by the agency to ensure its quality, efficacy and safety. The medical devices are released to the distributers only after they have been verified by the MHRA and CE marked. All the blood related services or products are approved only after they are verified against the Blood Safety and Quality Regulations.
Key Roles of MHRA
- Performing post marketing surveillance for investigation, reporting and monitoring of unacceptable reactions of drugs to medicines and medical device incidents.
- Assessing and authorizing medicines and medical devices for sale and supply within United Kingdom.
- Overseeing the Notified Bodies which are responsible for ensuring that the medical device manufactures are following the regulations before they are released in the market.
- Operating a surveillance system to test and sample medicines to check quality and defect and ensuring the quality and safety of unlicensed products.
- Investigation of internet medicine sales for potential counterfeits and taking necessary actions where needed.
- British Pharmacopoeia and General Practice Research Database management.
The MHRA is also involved in hosting and supporting some expert advisory groups. Such bodies include the British Pharmacopoeia Commission and the Commission on Human Medicine. MHRA can also become the rapporteur or co-rapporteur for a pharmaceutical application to perform the bulk of verification tasks on the behalf of the members.
