The MHRA checks the safety and quality standards of all healthcare products and ensures that they comply with European and UK laws and regulations. Inspections, reporting systems and intelligence about illegal activity all have key roles within the Agency’s safety monitoring system.
As well as its own inspection teams and proactive monitoring, the MHRA relies on manufacturers, healthcare professionals, and the public to report side effects, defects, and misleading information.
The MHRA monitors safety and quality standards of medicines and medical devices in several ways:
We carry out regular inspections to ensure good and safe practice in:
- manufacturers and suppliers of medicines and medical devices
- medicines distribution and storage
- clinical trials
- clinical inspecting systems for devices
- laboratories testing medicines
- auditing Notified Bodies
- blood establishments.
We carry out annual routine sampling of around 3,000 marketed medicines at manufacturers’ premises, wholesalers, and pharmacies, and a proactive medical device programme.
We collect ongoing reports from healthcare professionals, patients, and manufacturers on:
- potential side effects of prescription and over the counter medicines and herbal remedies (Yellow Card Scheme) - a register of these suspected side effects is maintained which helps provide early warnings of potential drug hazards.
- design faults/poor instructions or maintenance / incorrect use of devices (Adverse Incident Reporting Scheme)
- Defective medicines
- Serious side effects involving blood and blood components (SABRE).
We review important new evidence on specific products, such as antidepressants (SSRIs) or hormone replacement therapy (HRT), or devices such as implantable defibrillators used to correct irregular heart rhythms.
We commission research into medicines safety and support the Department of Health research and development initiatives on innovative medical device technology and technology related procedures.
We assess misleading or incorrect information within:
- adverts
- product labelling
- product information leaflets.
We gather intelligence about illegally manufactured imported and counterfeit medicines and medical devices.
We manage the General Practice Research Database (GPRD), Which contains information from which is used to detect healthcare trends and monitor the safety and risk benefits of market licensed medicines.
We ensure the legal enforcement of regulations and statutory obligations, including checks on unlicensed medicines and medical devices.
