Therapeutic Goods Administration (TGA)
- NewActon East, 23, Marcus Clarke Street, New Acton, City, Canberra, District of Canberra Central, Australian Capital Territory, 2601, Australia
- +61 2 6289 1555
- https://www.tga.gov.au
Medicines and Healthcare products Regulatory Agency (MHRA)
Company Overview
Phone
Email
Website
Address
HM Government, 10, South Colonnade, Canary Wharf, London Borough of Tower Hamlets, Greater London, England, E14 4PU, United Kingdom
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s national regulatory authority responsible for ensuring the safety, quality, and effectiveness of medicines, medical devices, and healthcare products. Established in 2003 and headquartered in London, United Kingdom, MHRA operates as an executive agency of the UK Department of Health and Social Care.
MHRA regulates a wide range of healthcare products, including prescription medicines, vaccines, biological therapies, medical devices, diagnostics, and advanced therapeutic products. The agency evaluates healthcare products before approval and continues monitoring their safety after they reach the market.
The organization performs critical regulatory activities including marketing authorization assessments, clinical trial approvals, Good Manufacturing Practice (GMP) inspections, pharmacovigilance monitoring, medical device surveillance, and enforcement of healthcare regulations.
MHRA works closely with pharmaceutical companies, biotechnology organizations, research institutions, healthcare professionals, and international regulatory authorities to maintain high standards of patient safety and product quality.
The agency provides regulatory guidance for drug development, clinical research, innovative therapies, artificial intelligence in healthcare, and medical technology. It also manages the UK’s Yellow Card Scheme for monitoring adverse reactions and healthcare product safety issues.
MHRA plays an important role in supporting innovation while ensuring that healthcare products meet strict standards of safety, quality, and effectiveness. The agency collaborates internationally with organizations such as the European Medicines Agency (EMA), U.S. FDA, and other regulatory bodies.
Through scientific expertise, inspections, and regulatory oversight, MHRA helps protect public health and supports the development of safe and effective medicines and healthcare technologies in the United Kingdom and globally.
Certifications
GMP Certified
Other Certifications & Accreditations
●Good Manufacturing Practice (GMP)
●Good Clinical Practice (GCP)
●UK Medical Device Regulations
●Pharmacovigilance Standards
●ICH Guidelines
●Quality Management Standards
●Good Clinical Practice (GCP)
●UK Medical Device Regulations
●Pharmacovigilance Standards
●ICH Guidelines
●Quality Management Standards
Company Size
Large (500+ employees)
Year Established
2003
Features
●Medicine regulation
●Medical device regulation
●Clinical trial authorization
●GMP inspections
●Pharmacovigilance
●Healthcare product monitoring
●Regulatory guidance
●Vaccine regulation
●Medical technology compliance
●Drug safety surveillance
●Medical device regulation
●Clinical trial authorization
●GMP inspections
●Pharmacovigilance
●Healthcare product monitoring
●Regulatory guidance
●Vaccine regulation
●Medical technology compliance
●Drug safety surveillance
Location
HM Government, 10, South Colonnade, Canary Wharf, London Borough of Tower Hamlets, Greater London, England, E14 4PU, United Kingdom
Review
Login to Write Your ReviewThere are no reviews yet.
Health Canada
- Address Locator 0900C2, Ottawa, Ontario K1A 0K9 Canada
- +1 866-225-0709
- https://www.canada.ca/en/health-canada.html
Pharmaceuticals and Medical Devices Agency (PMDA)
- Shin Kasumigaseki Building, Shuto Expressway Inner Circular Route, Kasumigaseki 3, Kasumigaseki, Chiyoda, Tokyo, 100-0013, Japan
- +81 3 3506 9456
- https://www.pmda.go.jp/