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Global Regulatory Agencies & Standards
A regulatory and standards reference for medical device, pharma, and biotech teams. Click through to any agency's official site.
International Standards & Harmonization
The bodies that set globally referenced standards and coordinate regulatory approaches across countries.
International Organization for Standardization
Global
Publishes ISO 13485 (device QMS), ISO 14971 (risk management), ISO 10993 (biocompatibility), and hundreds of other referenced standards.
Visit official siteInternational Council for Harmonisation
Global
Harmonizes pharmaceutical technical requirements through its Q (quality), S (safety), E (efficacy), and M (multidisciplinary) guidelines.
Visit official siteInternational Medical Device Regulators Forum
Global
Coordinates device regulatory approaches among major regulators worldwide; successor to the former GHTF.
Visit official siteWorld Health Organization
Global
Sets global health policy and runs the Prequalification Programme many countries rely on for drug and vaccine approval.
Visit official sitePharmaceutical Inspection Co-operation Scheme
Global
Harmonizes GMP inspection standards and mutual recognition among roughly 50 member authorities.
Visit official siteAsian Harmonization Working Party
Asia-Pacific
Asia-Pacific counterpart to IMDRF, focused on device regulatory convergence among emerging-market regulators.
Visit official sitePharmacopeias
Official compendia of drug quality standards and monographs referenced in submissions worldwide.
United States Pharmacopeia
United States
Sets quality standards and monographs for medicines, ingredients, and dietary supplements used in the U.S. and widely referenced abroad.
Visit official siteEuropean Pharmacopoeia (EDQM)
Europe
The pharmacopeia used across EU member states and beyond, maintained by the Council of Europe's EDQM.
Visit official siteJapanese Pharmacopoeia
Japan
Japan's official drug quality compendium, published under the Ministry of Health, Labour and Welfare.
Visit official siteBritish Pharmacopoeia
United Kingdom
The UK's official collection of drug quality standards, published on behalf of the MHRA.
Visit official siteAmericas
Food and Drug Administration
United States
Regulates drugs, biologics, and medical devices in the U.S.; CDER covers drugs and CDRH covers devices.
Visit official siteHealth Canada
Canada
Canada's federal regulator for drugs, medical devices, and health products.
Visit official siteComisión Federal para la Protección contra Riesgos Sanitarios
Mexico
Mexico's federal sanitary risk protection agency, covering drugs, devices, and food safety.
Visit official siteAgência Nacional de Vigilância Sanitária
Brazil
Brazil's national health surveillance agency for drugs, devices, and sanitary products.
Visit official siteAdministración Nacional de Medicamentos, Alimentos y Tecnología Médica
Argentina
Argentina's national regulator for medicines, food, and medical technology.
Visit official siteInstituto Nacional de Vigilancia de Medicamentos y Alimentos
Colombia
Colombia's national institute for drug and food surveillance.
Visit official siteInstituto de Salud Pública de Chile
Chile
Chile's public health institute, responsible for pharmaceutical and device regulation.
Visit official siteEurope
European Medicines Agency
European Union
Centrally authorizes many medicines across EU member states; devices fall under the EU MDR/IVDR framework with national competent authorities.
Visit official siteMedicines and Healthcare products Regulatory Agency
United Kingdom
The UK's independent regulator for medicines and devices, operating separately from the EU since Brexit.
Visit official siteSwiss Agency for Therapeutic Products
Switzerland
Switzerland's regulator for therapeutic products; Switzerland is not an EU member, so it runs its own approval process.
Visit official siteFederal Service for Surveillance in Healthcare
Russia
Russia's federal healthcare surveillance service, covering drugs and medical devices.
Visit official siteAsia-Pacific
Pharmaceuticals and Medical Devices Agency
Japan
Japan's device and drug review agency, operating under the Ministry of Health, Labour and Welfare (MHLW).
Visit official siteNational Medical Products Administration
China
China's national regulator, renamed from the former CFDA in 2018.
Visit official siteMinistry of Food and Drug Safety
South Korea
South Korea's regulator for drugs, biologics, and medical devices.
Visit official siteCentral Drugs Standard Control Organisation
India
India's national regulatory authority for drugs and medical devices.
Visit official siteHealth Sciences Authority
Singapore
Singapore's regulator for health products, and an active IMDRF member.
Visit official siteTaiwan Food and Drug Administration
Taiwan
Taiwan's regulator for food, drugs, and medical devices.
Visit official siteTherapeutic Goods Administration
Australia
Australia's regulator for medicines, biologics, and medical devices.
Visit official siteMedicines and Medical Devices Safety Authority
New Zealand
New Zealand's authority for medicine and medical device safety.
Visit official siteBadan Pengawas Obat dan Makanan
Indonesia
Indonesia's National Agency of Drug and Food Control.
Visit official siteNational Pharmaceutical Regulatory Agency
Malaysia
Malaysia's regulator for pharmaceuticals; medical devices are regulated separately by the Medical Device Authority (MDA).
Visit official siteFood and Drug Administration, Thailand
Thailand
Thailand's regulator for food, drugs, and medical devices.
Visit official siteFood and Drug Administration Philippines
Philippines
The Philippines' regulator for food, drugs, and medical devices.
Visit official siteDrug Administration of Vietnam
Vietnam
Vietnam's national drug administration authority.
Visit official siteMiddle East
Saudi Food and Drug Authority
Saudi Arabia
Saudi Arabia's regulator for food, drugs, and medical devices.
Visit official siteMinistry of Health and Prevention
United Arab Emirates
The UAE's federal health ministry, which oversees drug and device regulation alongside emirate-level bodies.
Visit official sitePharmaceutical Administration
Israel
Israel's health ministry oversees pharmaceutical and device regulation nationally.
Visit official siteEgyptian Drug Authority
Egypt
Egypt's national regulator for drugs and related health products.
Visit official siteJordan Food and Drug Administration
Jordan
Jordan's national regulator for food, drugs, and medical devices.
Visit official siteTurkish Medicines and Medical Devices Agency
Türkiye
Türkiye's national regulator for medicines and medical devices.
Visit official siteAfrica
South African Health Products Regulatory Authority
South Africa
South Africa's regulator for medicines, medical devices, and related health products.
Visit official siteNational Agency for Food and Drug Administration and Control
Nigeria
Nigeria's national regulator for food, drugs, and related products.
Visit official siteAfrican Medicines Agency
African Union
A newer continental body intended to support regulatory harmonization across African national regulators.
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