Pharmaceuticals: Regulatory Agencies

Argentina: National Administration on Drugs, Foods, and Medical Devices

The National Administration on Drugs, Foods, and Medical Devices, also known as Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), is responsible for the oversight and regulation of the healthcare, pharmaceuticals, and food and beverage industries within Argentina. The site contains information on regulations, press releases, and publications as well state agency and medical publications links. Some areas of the site are only available in Spanish.

Last reviewed by globalEDGE on: October 24, 2016

Tags: Country Specific , Food and Beverage , Healthcare , Argentina

Australia: Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration (TGA) is the regulatory authority for the Australian pharmaceutical industry. The TGA oversees and regulates numerous therapeutic goods including prescription medicines, vaccines, and medical devices. The site contains information catered specifically to consumers, health professionals, and industry manufacturers. It also lists recent pharmaceutical recalls and alerts.

Last reviewed by globalEDGE on: October 11, 2016

Tags: Country Specific , Australia

Bulgarian Drug Agency (BDA)

The Bulgarian Drug Agency (BDA) is responsible for overseeing the safe production of medicines in Bulgaria. The BDA inspects laboratories, drugs, and medical devices in order to ensure the quality and safety of drug use. Their site includes useful information for citizens, medical specialists, and companies regarding medical laws, devices, and treatments.

Last reviewed by globalEDGE on: October 13, 2016

Tags: Country Specific , Bulgaria

China Food and Drug Administration (CFDA)

The website for the China Food and Drug Administration (CFDA) displays important information in regards to the laws and regulations of food and drug production. Additionally, the site allows users to search by type of drug or ingredients to find corresponding regulations and laws. Recent news about the industry is provided on the homepage.

Last reviewed by globalEDGE on: October 25, 2016

Tags: Country Specific , Food and Beverage , China

Czech Republic: State Institute for Drug Control (SUKL)

The State Institute for Drug Control (SUKL) regulates the safe production of pharmaceuticals in the Czech Republic. SUKL is responsible for the surveillance of advertising and marketing medicines and medical devices. The site contains various databases which allow users to search for clinical trials, medicinal products, and pharmacies. Articles covering the results of recent clinical trials are also posted on the homepage.

Last reviewed by globalEDGE on: October 26, 2016

Tags: Country Specific , Czech Republic

Denmark: Danish Health and Medicines Authority (DHMA)

The Danish Health and Medicines Authority (DHMA) is responsible for the oversight and regulation of the healthcare and pharmaceutical industries within Denmark. The site contains information on licensing and supervision, product information, medical devices, pharmacies, and sale of medicines. A library of publications about pharmaceutical research and developments is also available.

Last reviewed by globalEDGE on: October 27, 2016

Tags: Country Specific , Healthcare , Denmark

Estonia: Agency of Medicines

The Agency of Medicines of Estonia is charged with the oversight and regulation of the healthcare and pharmaceuticals industries within Estonia. The site contains information on regulations, drug trials, and proper healthcare techniques in Estonia.

Last reviewed by globalEDGE on: November 1, 2016

Tags: Country Specific , Healthcare , Estonia

European Medicines Agency

The European Medicines Agency (EMA) protects and promotes public health through the evaluation of medicines. The EMA provides recommendations on the quality and safety of medicines. They apply evaluation procedures to help bring new medicines to the European Union.

Last reviewed by globalEDGE on: October 17, 2012

Tags: Europe , Region Specific

Finland: Finnish Medicines Agency (Fimea)

The Finnish Medicines Agency (Fimea) promotes the health and safety of the population by regulating medicinal, blood and tissue products, and by developing the pharmaceuticals sector. The site provides medicine databases, a directory of pharmacies, and veterinary information.

Last reviewed by globalEDGE on: October 28, 2016

Tags: Country Specific , Finland

Germany: Federal Institute for Drugs and Medical Devices (BfArM)

The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for licensing and registering finished medicinal products as proof of safety and efficacy. BfArM monitors the risks of medicinal products by collecting and evaluating laboratory reports. The institute also evaluates and develops safe medical devices in Germany. The BfArM site contains information about the institute and its functions, medicinal products, and medical devices. Various research documents covering topics such as pharmacogenomics, pharmacoepidemiology, safety of medical devices, neuropsychopharmacology, special indications, and biostatistics are also available. 

Last reviewed by globalEDGE on: October 17, 2016

Tags: Country Specific , Healthcare , Germany

Greece: National Organization for Medicines

Greece's National Organization for Medicines (EOF) protects public health in relation to medicinal products, medical devices, supplements, and cosmetics. EOF evaluates new safe and effective products, control the production of medicines to meet the standards of good manufacturing, and promotes medical and pharmaceutical research. The site provides announcements for various products and laws. Only available in Greek.

Last reviewed by globalEDGE on: October 17, 2016

Tags: Country Specific , Greece

Hong Kong: Department of Health - Drug Office

Hong Kong's Drug Office is responsible for the market surveillance of medicines, risk assessments, and complaints of drugs. Additionally, the office is in charge of inspecting the drugs, licensing manufacturers and retailers, and conducting research and development for the improvement of drug standards. The site is designed to provide specific information for consumers, healthcare providers, and those interested in pharmaceutical trade, and the homepage offers sections that are specific to these audiences.

Last reviewed by globalEDGE on: October 18, 2016

Tags: Country Specific , Hong Kong

Hungary: National Institute of Pharmacy and Nutrition

The National Institute of Pharmacy and Nutrition is a licensing authority for medicinal products, and it is also responsible for the authorization of duty-free donations of medicines in and out of Hungary. The institute evaluates medicines, issues licenses, and supervises medical testing. The site includes news, authorization, supervision, methodology, and drug information. Some information only available in Hungarian.

Last reviewed by globalEDGE on: November 7, 2016

Tags: Country Specific , Hungary

Icelandic Medicines Agency (IMA)

The Icelandic Medicines Agency (IMA) is responsible for assessing the quality and safety of medicinal products in Iceland. They provide inspections to confirm that regulatory requirements are fulfilled. The IMA is also a source of information for health professionals and the public.

Last reviewed by globalEDGE on: November 7, 2016

Tags: Country Specific , Iceland

India: Central Drugs Standard Control Organization

The Central Drugs Standard Control Organization in India sets standards and regulatory measures for medications. The organization provides guidance on health issues and medicines. They also regulate the standards of imported drugs and clinical research in India. Various regulatory documents and forms are available for free PDF download from the website.

Last reviewed by globalEDGE on: October 17, 2016

Tags: Country Specific , India

Ireland: Health Products Regulatory Authority (HPRA)

The Health Products Regulatory Authority (HPRA) protects the public and animal health by regulating medicines, medical devices, and healthcare products. They also monitor the safety of cosmetics. The HPRA website includes product listings, descriptions of different medicines, current topics in medicine and legislation, as well as news and publications.

Last reviewed by globalEDGE on: October 19, 2016

Tags: Country Specific , Ireland

Italian Medicines Agency (AIFA)

The Italian Medicines Agency (AIFA) promotes good health through medicines by setting pharmaceutical policies and assuring their consistent application nationwide. AIFA promotes pharmaceutical research and development to further the safety and efficiency of drugs and medical devices. The site provides information for pricing and reimbursement, medical and scientific information, assessment and registration, and inspections and certifications.

Last reviewed by globalEDGE on: October 18, 2016

Tags: Country Specific , Italy

Japan: National Institute of Health Sciences (NIHS)

The National Institute of Health Sciences (NIHS) conducts testing, research, and studies toward the proper evaluation of the quality, safety, and efficacy of pharmaceutical products, foods, and the numerous chemicals in the living environment. The site includes information on drugs, medical devices, food, and chemicals as well as general information on the NIHS.

Last reviewed by globalEDGE on: October 31, 2016

Tags: Country Specific , Healthcare , Japan

Japan: National Institute of Infectious Diseases (NIID)

The National Institute of Infectious Diseases (NIID) is a research institute attached to the Ministry of Health, Labor and Welfare for conducting fundamental and applied research on infectious diseases and setting testing standards for the development of antibiotics and vaccines. The NIID website contains information about the institute, its recent research, and recent news articles. 

Last reviewed by globalEDGE on: October 31, 2016

Tags: Country Specific , Japan

Latvia: State Agency of Medicines of Latvia (SAMLV)

The State Agency of Medicines of Latvia (SAMLV) implements local and international legislation to ensure that human medicines and medical devices are safe and efficient. SAMLV provides objective information on medicines while ensuring inspection, accreditation, and certification of drug manufacturers and distributors.The SAMLV site contains information about pharmaceutical legislation, services provided by the agency, and recent news posts related to the agency's activities.

Last reviewed by globalEDGE on: May 2, 2016

Tags: Country Specific , Latvia

Lithuania: State Medicines Control Agency (SMCA) of Lithuania

The State Medicines Control Agency (SMCA) of Lithuania is responsible for the protection of public health through the evaluation and supervision of medicines for human use. The SMCA supervises manufacturing authorization holders, wholesale distributors, and pharmacies in Lithuania.

Last reviewed by globalEDGE on: November 1, 2016

Tags: Country Specific , Lithuania

Malaysia: National Pharmaceutical Regulatory Agency (NPRA)

The National Pharmaceutical Regulatory Agency (NPRA) in Malaysia ensures the quality and safety of pharmaceutical products. The NPRA site contains information about the agency, lists of guidelines and updates, and a product search feature.

Last reviewed by globalEDGE on: November 7, 2016

Tags: Country Specific , Malaysia

Malta: Medicines Authority

The mission of the Medicines Authority is the protection of public health in Malta through the regulation of medicinal products and pharmaceutical activities. The authority provides licensing, monitoring, and inspection services for pharmaceutical activities.

Last reviewed by globalEDGE on: November 8, 2016

Tags: Country Specific , Malta

Netherlands: Medicines Evaluation Board (MEB)

The Medicines Evaluation Board (MEB) assesses and guards the efficacy, safety, and quality of both human and veterinary medicinal products. The MEB is the primary source of information on new medicinal products, new applications, and current risk information in the Netherlands.

Last reviewed by globalEDGE on: November 7, 2016

Tags: Country Specific , Netherlands

New Zealand Medicines and Medical Devices Safety Authority

New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is accountable for the regulation of therapeutic products in New Zealand. Medsafe ensures that medicines meet acceptable standards of safety and quality. They also provide information about medicine to health care professionals, consumers, and industry professionals. Information is provided on medicines, devices, dietary supplements, safety, news and events, and publications.

Last reviewed by globalEDGE on: November 11, 2016

Tags: Country Specific , New Zealand

New Zealand: Pharmaceutical Management Agency (PHARMAC)

New Zealand's Pharmaceutical Management Agency (PHARMAC) is responsible for the safe production of medicine and medical devices. PHARMAC provides information to citizens and healthcare professionals regarding drugs and devices. PHARMAC is also now responsible for management of hospital pharmaceuticals

Last reviewed by globalEDGE on: November 11, 2016

Tags: Country Specific , New Zealand

Norwegian Medicines Agency (NoMA)

The Norwegian Medicines Agency (NoMA) is responsible for updating and safeguarding public and animal health by ensuring the efficacy, quality, and safety of medicines. NoMA is also responsible for the authorization, pricing, and classification of medicines. Furthermore, NoMA provides information about clinical trials, regulatory affairs, and pharmacovigilance.

Last reviewed by globalEDGE on: November 7, 2016

Tags: Country Specific , Norway

Portugal: National Institute of Pharmacy and Medicines (INFARMED)

The National Institute of Pharmacy and Medicines (INFARMED) is accountable to the Health Ministry of Portugal. The objective of INFARMED is to monitor, assess, and regulate all activities relating to human medicines and health products for the protection of public health. The site provides detailed information regarding medicinal products, medical devices, cosmetics, licensing bodies, and monitoring the market.

Last reviewed by globalEDGE on: November 10, 2016

Tags: Country Specific , Portugal

Romania: National Agency for Medicines and Medical Devices (NAMMD)

The National Agency of Medicines and Medical Devices (NAMMD) surveys the safety of medicinal products for human use in Romania. The NAMMD maintains a high level of performance and safety of medical devices in use by healthcare networks. The agency also ensures access to useful information on medicinal products for patients and healthcare professionals.

Last reviewed by globalEDGE on: November 8, 2016

Tags: Country Specific , Romania

Serbia: Medicines and Medical Devices Agency (ALIMS)

The Medicines and Medical Devices Agency of Serbia (ALIMS) provides high quality, safe, and effective drugs and medical devices to the Serbian citizens. ALIMS provides information of the use of drugs and medical devices and performs tests to ensure the quality control of drugs.

Last reviewed by globalEDGE on: June 17, 2016

Tags: Country Specific , Healthcare , Serbia

Slovakia: State Institute for Drug Control (SIDC)

The State Institute for Drug Control (SIDC) is a part of the Ministry of Health of the Slovak Republic and is responsible for ensuring the surveillance of the quality and safety of medicinal products. SIDC supervises pharmacies and controls advertisements of medicinal products.

Last reviewed by globalEDGE on: November 17, 2016

Tags: Country Specific , Slovakia

Slovenia: Ministry of Health

The Ministry of Health is concerned with matters relating to healthcare and health insurance in Slovenia. The ministry monitors the nation's health programs and health measures to be taken in the event of natural disasters. It also protects the population against diseases and other health problems, especially pertaining to environmental harms like toxic water or waste.

Last reviewed by globalEDGE on: November 17, 2016

Tags: Country Specific , Slovenia

South Korea: Ministry of Food and Drug Safety (MFDS)

South Korea's Ministry of Food and Drug Safety (MFDS) seeks to secure national health and safety of its citizens, mainly through its operations in the food and drug industries. This is done through the enhancement of risk management systems, tightened safety control, and reform on safety regulations. The site provides information on the ministry's projects, relative market news, and economic statistics.

Last reviewed by globalEDGE on: November 18, 2016

Tags: Country Specific , South Korea

Spain: Medicine and Health Products Agency

The Spanish Agency for Medicine and Health Products evaluates and authorizes medicines for human and veterinary use. They continuously monitor the safety and efficacy of medicines as well as license and inspect pharmaceutical laboratories. The agency also fights against illegal drugs and counterfeit health products.

Last reviewed by globalEDGE on: November 15, 2016

Tags: Country Specific , Spain

Sweden: Medical Products Agency (MPA)

The Medical Products Agency (MPA) is responsible for regulating and monitoring the development of drugs and medicinal products. MPA's website contains a wealth of information regarding herbal, homeopathic, and other types of medicinal products as well as medical devices. Recent news releases from the MPA regarding recalls or updates in the pharmaceutical industry are also posted on the homepage of the site. 

Last reviewed by globalEDGE on: June 7, 2016

Tags: Country Specific , Sweden

Switzerland: Swiss Agency for Therapeutic Products (Swissmedic)

The Swiss Agency for Therapeutic Products (Swissmedic) ensures that authorized therapeutic products are of high quality, effective, and safe. Its goal is to protect the health of humans and animals and to also safeguard Switzerland as a location for industry and research. Their site provides the latest news in the Swiss therapeutic industry and information on licensing, authorizations, market surveillance, and legal matters.

 

Last reviewed by globalEDGE on: November 29, 2016

Tags: Country Specific , Switzerland

United Kingdom: Association of the British Pharmaceutical Industry (ABPI)

The Association of the British Pharmaceutical Industry (ABPI) represents research-based companies, bringing life-saving medicines to patients. ABPI researches and develops current medicines to ensure that the UK is at the forefront of helping patients prevent diseases. This site includes information on industry achievements as well as a future outlook on medicinal research. 

Last reviewed by globalEDGE on: July 21, 2016

Tags: Country Specific , United Kingdom

United Kingdom: Medicines and Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring proper use of medicine and medical devices. The MHRA is an executive agency of the Department of Health.

Last reviewed by globalEDGE on: July 26, 2016

Tags: Country Specific , United Kingdom

United Kingdom: NHS Prescription Services

NHS Prescription Services is a service that calculates how much pharmacists should be paid as reimbursement for medicines and medical devices dispensed to patients from NHS prescription forms. NHS Prescription Services provides information to prescribers and organizations, making available financial and drug information.

Last reviewed by globalEDGE on: July 26, 2016

Tags: Country Specific , United Kingdom

United States: Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines safer, more effective, and more affordable.

Last reviewed by globalEDGE on: September 20, 2016

Tags: Country Specific , United States

Glossary