Global Pharmaceutical
Regulatory Authorities & Useful Links
This curated resource page provides direct access to the world’s leading pharmaceutical regulatory authorities, international healthcare organizations, and pharmacovigilance frameworks. Whether you are a pharmaceutical company, regulatory professional, or researcher, staying connected to these authoritative sources is essential for maintaining compliance and staying ahead of evolving regulatory standards.
Direct links to national and regional pharmaceutical regulatory authorities worldwide — the primary sources for drug approval guidelines, licensing requirements, and compliance frameworks in their respective jurisdictions.
US
FDA
USA
US Food and Drug Administration
The FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs....
IN
CDSCO
INDIA
Central Drugs Standard Control Organization
CDSCO is the national regulatory body of India responsible for the approval of new drugs, clinical trials, and the licensing of...
EU
EMA
European Union
European Medicines Agency
The EMA is a decentralized EU agency responsible for the scientific evaluation, supervision, and safety monitoring of...
JP
PMDA
Japan
Pharmaceuticals and Medical Devices Agency
PMDA conducts reviews of pharmaceutical products, ensures post-marketing safety, and provides relief services for adverse health...
GB
MHRA
United Kingdom
Medicines and Healthcare Products Regulatory Agency
MHRA is the UK government agency responsible for ensuring that medicines, medical devices, and blood components meet...
AU
TGA
Australia
Therapeutic Goods Administration
The TGA is Australia's regulatory authority for therapeutic goods, responsible for evaluating, assessing, and monitoring products including...
CA
Health Canada
Canada
Health Canada
Health Canada is the federal department responsible for helping Canadians maintain and improve their health, including the...
CN
NMPA
China
National Medical Products Administration
NMPA oversees the regulation of drugs, medical devices, and cosmetics in China — responsible for product registration, licensing,...
BR
ANVISA
Brazil
National Health Surveillance Agency
ANVISA is Brazil's federal regulatory agency responsible for sanitary control of products and services that pose health risks —...
ZA
SAHPRA
South Africa
South African Health Products Regulatory Authority
SAHPRA is responsible for the regulation of health products in South Africa, ensuring their safety, quality, and efficacy through rigorous
KE
PPB
Kenya
Pharmacy and Poisons Board
The PPB is the national regulatory authority in Kenya responsible for regulating the practice of pharmacy and the manufacture, trade, and...
SA
SFDA
Saudi Arabia
Saudi Food and Drug Authority
SFDA is the regulatory authority in Saudi Arabia overseeing the safety, efficacy, and quality of food, drugs, medical devices, and...
SG
HSA
Singapore
Health Sciences Authority
HSA is Singapore's regulatory authority responsible for ensuring the safety, quality, and efficacy of health products — including....
KR
MFDS
South Korea
Ministry of Food and Drug Safety
MFDS is the South Korean government body responsible for ensuring the safety and effectiveness of food, drugs, cosmetics,
WHO
World Health Organization
The WHO is the leading international body for public health, responsible for coordinating global health responses, setting international healthcare standards, and leading pharmaceutical regulatory harmonisation efforts worldwide.
ICH
International Council for Harmonisation
ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration, developing internationally recognized guidelines for drug quality, safety, and efficacy.
CIOMS
Council for International Organizations of Medical Sciences
CIOMS is an international non-governmental organization that works closely with WHO to develop international ethical guidelines for biomedical research and pharmacovigilance standards.
BMA
British Medical Association
The BMA is a professional association and independent trade union representing doctors and medical students in the UK, providing scientific and policy guidance on medical practice and healthcare regulation.
WMA
World Medical Association
The WMA represents the interests of physicians globally, developing ethical standards and policies on topics including clinical research, patient rights, and pharmaceutical trial conduct.
ISoP
International Society of Pharmacovigilance
ISoP is a non-profit scientific organization dedicated to advancing pharmacovigilance globally — promoting drug safety science, education, and the application of best practices in medicines monitoring.
Pharmacovigilance Europe
A dedicated European resource providing comprehensive information, educational materials, and updates on pharmacovigilance regulations, case reporting standards, and safety monitoring frameworks across the EU.
Global Patient Safety Alerts
A centralized platform that aggregates safety alerts, drug recalls, and regulatory warnings from health authorities worldwide — enabling pharmaceutical professionals to monitor and respond to emerging safety signals promptly.
WHO Global Pharmacovigilance Programme
The WHO's dedicated pharmacovigilance programme that collects and analyzes adverse drug reaction data from member countries through the Uppsala Monitoring Centre — supporting global drug safety surveillance.
If your organization requires expert assistance with regulatory submissions, dossier preparation, pharmacovigilance compliance, or clinical trial coordination, our experienced team at ZEDKEYGLOBALCONNECT is ready to provide the strategic guidance and hands-on support you need.