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United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA)

The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) is the Competent Authority that handles medicinal products, blood products, advanced therapy products (gene therapy, somatic cell therapy, and tissue-engineered products), and devices for the United Kingdom (England, Wales, Scotland, Northern Ireland). Under the chief executive are five divisions. One, the Vigilance Risk Management of Medicines (VRMMM) Division, primarily handles drug safety matters. Device safety is handled by the Device Technology and Safety Division, inspections by the Inspection, Enforcement and Standards Division, and new approvals by the Licensing Division.

As the United Kingdom is a member of the European Union, safety and pharmacovigilance (PV) are also handled centrally by the European Medicines Agency (EMA) (see Chapter 22). Thus, the United Kingdom operates under Volume 9A and Volume 10 for postmarketing and clinical trial safety as well as the core Directive 2001/83/EC, amended by Directives 2002/98/EC, 2003/63/EC, 2004/24/EC, and 2004/27/EC.

The MHRA has an extensive website (Web Resource 24-1).

The “Medicines” section (Web Resource 24-2) covers drugs, homeopathics, herbals, and licensing (Marketing Authorizations), inspections, names, pediatric medications, labeling, and other topics.

The “Safety” section covers warnings, alerts, and recalls, and has sections for reporting AEs (the Yellow Card Scheme), product-specific advice, and information for healthcare professionals. Drug safety is monitored by multiple methods, including regular (and directed) inspections of manufacturers and suppliers, distributors and storage, clinical trials, laboratories, Notified Bodies (organizations—often private companies—authorized to provide various services, including safety reviews, design examinations, and other aspects of devices in the European Union), and blood establishments. The MHRA also collects reports of AEs via its Yellow Card Scheme, examines advertising, labeling, and promotional material, and can commission research on safety. The MHRA also manages the General Practice Research Database (GPRD) (see Chapter 8).

For marketed drug products, the United Kingdom relies on the voluntary spontaneous reporting of AEs by healthcare professionals and consumers as most other countries do. (Industry reporting of AEs is obligatory.) The system is known as the Yellow Card Scheme and is run by the MHRA and the Commission on Human Medicines. The system receives reports of suspected adverse drug reactions (ADRs) from healthcare professionals and consumers/patients. The system was started in 1964, and the original form was a “yellow card.”

Patients are encouraged to report all side effects (Web Resource 24-3) while healthcare professionals (Web Resource 24-4) are instructed to report all suspected ADRs on new medicines (which are identified by a black triangle [] on the label [see below]) and only serious ADRs for established medicines. This is in contrast to many health authorities (HAs), which instruct healthcare professionals to report all AEs. Reporting may be done online, by downloading the form, filling it in and mailing it, or by e-mailing it to one of several centers around the country. The form is rather simple (and is similar to the MedWatch and CIOMS I forms) and requests data on the patient, the reaction (including its seriousness and outcome), comedications and other relevant information, and the reporter–clinician details. The site contains some basic information on what an ADR is and how to evaluate causality, though the MHRA notes that the healthcare professional should report “if you have the slightest suspicion that there might be an association…do not refrain from reporting simply because you are not certain about cause and effect.”

The data from the Yellow Cards are entered into the MHRA’s ADR database and used for analysis and signal evaluation. Much of the data from the database is available directly online as “Drug Analysis Printouts” (Web Resource 24-5) (see Chapter 8 and the section below).

Newly approved drugs (usually a new chemical entity, but an older drug if it has a new combination of actives, a new delivery system, a new indication, or a new patient population) are noted by a black triangle. All new biologics have a black triangle. Older drugs, which were black triangle drugs and which moved out of that category but which move back into it (“reinstated”) due to new information or a new indication or population, are asterisked: *

The goal is to alert the prescriber and user that this is a new product whose safety profile is not as complete as established drugs and to more intensively monitor and collect safety information. It appears on advertising material. A product will stay on the list for 2 years as a rule but may remain on longer if appropriate. Industry is requested to report all serious cases from the United Kingdom and European Union (not just those not appearing in the Summary of Product Characteristics [SPC] labeling). Black triangle drugs are listed on the website.

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