MHRA
From 1 April 2003, the Medicines and Healthcare products Regulatory Agency (MHRA) replaced the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA). The MHRA is an Executive Agency of the Department of Health with trading fund status.
The Agency is committed to safeguarding public health by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.
MHRA Key Activities
- Regulating medical devices.
- Licensing of medicines before marketing and subsequent variations.
- Regulation of clinical trials.
- Operating adverse incident reporting system for medical devices.
- Issuing safety warnings.
- Responsibility for reporting, assessment and communications of defective medicines.
- Monitoring of medicines and acting on safety concerns after marketing.
- Ensuring compliance to standards of pharmaceutical manufacture and wholesaling.
- Enforcement of requirements.
- Evaluating medical devices to inform purchasing and encourage safe use.
- Managing the General Practice Research Database (GPRD).
- Setting quality standards for drug substances through the "British Pharmacopoeia".
- Providing advice and guidance on medicines and medical devices.