regulatory agencies

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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