Resources – Regulatory
Agencies
Regulatory agencies and organizations play a vital role in meeting the requirements of legal procedures related to drug development. Currently, pharmaceuticals are considered the most highly regulated industry worldwide. Each government regulatory body ensures compliance with various legal and regulatory aspects of each approved drug or medical device. Nearly every country has at least one of its own regulatory authorities. These agencies are responsible for enforcing the rules and regulations and issuing the guidelines that regulate drug development processes, licensing, registration, manufacturing, marketing, and labeling pharmaceutical products.
Here at Metis, our global go-to guiding agency for Pharmaceutical and Biotech industry is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). But there are many agencies Globally, and we have linked some below.
North America
FDA | FDA (CBER) | FDA (CDER)
United States (Device) FDA (CDRH) | NIST
Canada Health Canada
European Union
European Medicines Agency EMA
Heads of Medicines Agencies HMA
European Commission Public Health
EU Member States
Austria Federal Ministry of Health
Belgium Federal Agency for Medicines & Health Products
Bulgaria Bulgarian Drug Agency
Croatia Agency for Medicinal Products and Medical Devices | Ministry of Health
Cyprus Ministry of Health
Czech Republic State Institute for Drug Control
Denmark Danish Medicines Agency
Estonia State Agency of Medicines
Finland Finnish Medicines Agency | National Supervisory Authority for Welfare and Health
France National Agency for the Safety of Medicines and Health Products (ANSM)
Germany Federal Institute for Drugs and Medical Devices (BfArM)
Greece National Organisation for Medicines (EOM)
Hungary National Institute of Pharmacy and Nutrition
Ireland Health Products Regulatory Authority
Italy Italian Medicines Agency
Latvia State Agency of Medicines | Ministry of Health
Lithuania State Medicines Control Agency (SMCA)
Malta Medicines Authority
Netherlands Medicines Evaluation Board | Health Care Inspectorate (IGZ)
Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) | Ministry of Health
Portugal National Authority of Medicines and Health
Romania The National Agency for Medicines and Medical Devices (NAMMD)
Slovak Republic State Institute for Drug Control
Slovenia Agency for Medicinal Products and Medical
Spain Ministry of Health, Social Services and Equality
Sweden Medical Products Agency
United Kingdom Medicines and Healthcare Products Regulatory Agency
Non-EU Member States
Albania National Agency on Drugs and Medical Devices | Ministry of Health and Social Protection
Belarus Center for Examinations and Tests in Health
Bosnia & Herzegovina Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina | Ministry of Health of the Federation of Bosnia and Herzegovina
Iceland Icelandic Medicines Agency
Kosovo Kosovo Medicines Agency | Ministry of Health
Macedonia Agency for Medicinal Products and Medical Devices | Ministry of Health
Montenegro Agency for Medicines and Medical Devices | Ministry of Health
Norway Norwegian Medicines Agency
Russia Federal Service on Surveillance in Healthcare and Social Development | Ministry of Health Care
Serbia | Medicines and Medical Devices Agency of Serbia | Ministry of Health
Switzerland Swiss Agency for Therapeutic Products
Turkey Turkish Medicines and Medical Devices Agency
Ukraine State Inspectorate for Quality Control of Medicines | Ministry of Health Care
South America
Argentina National Administration of Drugs, Foods and Medical Devices (ANMAT)
Brazil Brazilian Health Surveillance Agency (ANVISA)
Chile Public Health Institute of Chile (ISPCH)
Colombia Ministry of Health and Social Protection
Costa Rica Ministry of Health
Ecuador National Agency for Regulation, Control and Sanitary Surveillance (ARCSA)
Mexico Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
Panama Ministry of Health
Peru General Directorate of Medicines, Supplies and Drugs (DIGEMID)
Venezuela National Institute of Hygiene “Rafael Rangel” | Autonomous Health Service Comptroller (SACS)
Africa
Algeria Ministry of Health, Population and Hospital
Kenya Pharmacy and Poisons Board (PPB)
Morocco Ministry of Health
Nigeria National Agency for Food and Drug Administration and Control (NAFDAC)
South Africa Medicines Control Council | Department of Health
Asia and Pacific
China China Food and Drug Administration
Hong Kong Department of Health | Central Drugs Standard Control Organization
India Central Drugs Standard Control Organization
Indonesia Ministry of Health
Japan Pharmaceuticals and Medical Devices Agency (PMDA) | Ministry of Health, Labour and Welfare (MHLW)
Kazakhstan National Center of Drugs, Medical Products and Medical Equipment Examination
Malaysia National Pharmaceutical Regulatory Agency | Medical Device Authority
New Zealand New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE)
Philippines Department of Health
ROC (Taiwan) Taiwan Food and Drug Administration
Singapore Health Sciences Authority
South Korea Korea Food and Drug Administration
Sri Lanka Cosmetics, Devices & Drugs Regulatory Authority | Ministry of Health
Thailand Bureau of Drug Control | Medical Device Control Division
Vietnam Drug Administration of Vietnam | Medical Devices Department, Ministry of Health
Middle East
Bahrain National Health Regulatory Authority
Egypt Ministry of Health and Population | Egyptian Drug Authority (EDA)
Iraq Ministry of Health
Israel Ministry of Health
Jordan Jordan Food and Drug Administration (JFDA)
Kuwait Kuwait Institute for Medical Specialization
Lebanon Ministry of Public Health
Oman Ministry of Health Sultanate of Oman
Qatar MOH Pharmacy and Drug Control Department
Saudi Arabia Saudi Food and Drug Authority (SFDA)
United Arab Emirates Ministry of Health
Organizations and Standards Agencies
ANZTPA Australia New Zealand Therapeutic Products Agency
Asian Harmonization Working Party AHWP
Association of Southeast Asian Nations ASEAN
Council for International Organizations of Medical Sciences CIOMS
GCC Health Ministers’ Council for GCC States
International Conference on Harmonization ICH
International Medical Device Regulators Forum IMDRF
International Organization for Standardization ISO
League of Arab States League of Arab States (LAS)
MedTech Europe MedTech Europe
MERCOSUR MERCOSUR
Organization for Economic Co-operation and Development OECD
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme PIC/S
World Health Organization WHO
World Medical Association WMA
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