What is the MHRA in the UK?

What we do. The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care.

What is the MHRA equivalent in the US?

The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) and the Food and Drug Administration (FDA) of the United States of America (US) are the regulatory authorities (collectively, the regulatory authorities) with responsibility in their respective countries for the authorisation, ...

What is the purpose of MHRA?

The MHRA makes sure that any medicine or medical device is safe to use, and it meets the required quality and regulatory standards. A medical device can be anything from a plaster to an asthma inhaler or a ventilator used within a hospital setting.

What is the MHRA responsible for?

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.

What is the UK version of the FDA?

The Medicines and Healthcare products Regulatory Agency ( MHRA ) is responsible for regulating the UK medical devices market.

The role of the Medicines and Healthcare Products Regulatory Agency

What is the difference between MHRA and FDA?

However, the main difference between MHRA and the FDA is actually the scope of the products we regulate. In the UK we have a separate regulator for food, for veterinary medicines, and for consumer products such as cosmetics, and we don't regulate tobacco, though we do have a role in registering nicotine e-cigarettes.

Who regulates food in the UK?

Established in 2000 following several high-profile outbreaks of foodborne illness, the Food Standards Agency (FSA) is the independent government department working to protect public health and consumers' wider interests in relation to food in England, Wales and Northern Ireland.

What needs to be reported to MHRA?

Report suspected side effects to medicines, vaccines, e-cigarettes, medical device incidents, defective or falsified (fake) products to the Medicines and Healthcare products Regulatory Agency to ensure safe and effective use. Find the medicine / vaccine / device you wish to report.

Who heads the MHRA?

Dame June Raine DBE (Chief Executive)

Does MHRA cover Scotland?

MHRA: the regulator for new medicines in Scotland.

Is MHRA a competent authority?

The Medicines and Healthcare products Regulatory Agency ( MHRA ) is the designating and competent authority in the UK.

Which body in the UK regulates the medical profession?

General Medical Council (GMC) regulates doctors. General Optical Council (GOC) regulates the optical professions. General Osteopathic Council (GOsC) regulates the practice of osteopathy. General Pharmaceutical Council (GPhC) regulates pharmacists, pharmacy technicians and pharmacy premises in Great Britain.

What is MHRA accreditation?

The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, in particular for those conducting first in human ( FIH ) trials. The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.

What was the old name of MHRA?

The Medicines and Healthcare products Regulatory Agency (MHRA) was established in April 2003 by the merger of the Medicines Control Agency (MCA) which had responsibility for regulating medicines in the UK and the Medical Devices Agency (MDA) which had a similar responsibility for medical devices.

What does POM stand for in medication?

Prescription-only medicines (POMs) are a specific class of medicine. A POM has to be prescribed by a doctor or other authorised health professional and it has to be dispensed from a pharmacy or from another specifically licensed place.

Is MHRA and EMA same?

In the UK, two agencies license drugs. They are the: European Medicines Agency (EMA) for a Europe-wide licence, under the European Commission laws. Medicines and Healthcare Products Regulatory Agency (MHRA) for a UK licence.

How do drugs get approved in the UK?

In the UK, licences are granted by the Medicines and Healthcare products Regulatory Agency (MHRA). Licences confirm the health condition the medicine should be used for and the recommended dosage. This can be found in the information leaflet that comes with the medicine.

What is the purpose of nice?

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. NICE is an executive non-departmental public body, sponsored by the Department of Health and Social Care.

Who is the pharmaceutical regulatory authority of USA?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

What is the yellow card in the hospital?

The MHRA runs the Yellow Card scheme, which collects and monitors information on suspected safety concerns involving healthcare products, like a side effect with a medicine or an adverse medical device incident.

How does the MHRA regulate?

Our responsibilities are to: ensure medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy (effectiveness) secure safe supply chain for medicines, medical devices and blood components.

Which organs are most likely to be affected by ADRs?

The liver is the main organ of drug metabolism, so it is the most vulnerable to adverse drug reactions (ADRs) (1, 2). Liver-related ADR (L-ADR) is one of the most common severe ADR in clinical settings and may lead to liver failure and even death (3, 4).

Who inspects restaurants UK?

Environmental Health Officers monitor and enforce health and hygiene. This applies to all food businesses (restaurants, bars, pubs etc.) of any size. They inspect businesses every 6 months to 3 years, depending on the level of risk.

Is Haccp a legal requirement in the UK?

The Legislation

Under Article 5 of Regulation (EC) 852/2004, food businesses must put in place, implement and maintain a food safety management system based on Hazard Analysis Critical Control Points (HACCP) principles to ensure the food produced from their premises is safe to eat.

What are the 4 C's of food safety?

The 4Cs of food hygiene

Cleaning. Cooking. Chilling. Cross-contamination.