Saturday, July 24, 2010

International guidelines and regulatory bodies

Links to important international guidelines and regulatory bodies


WHO (Medicines)

WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.

WHO sites

WHO guidelines on all areas relevant to health of people all over.

ICH

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States

OECD

Organization for Economic Collaboration and Development including 30 member countries covers economic and social issues in areas of health care.

EMEA

European Medicines Agency (EMEA), a decentralised body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union.

US FDA

Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.

TGA

Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.

South Africa

The department of Health, South Africa.

WTO

News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations.

Codex Alimentarius

Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.

MHRA

News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK.

Health Canada

Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.

Thai FDA

Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.

HSA, Singapore

Health Sciences Authority (HSA), the regulatory body of Singapore.

DOH, Philippines

The Department of Health, Philippines.

Medsafe,

New Zealand

Medsafe, New Zealand Medicines and Medical Devices Safety Authority.

NPCB, Malaysia

Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.

DGMP, Belgium

Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.

BfArM, Germany

Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany

SwissMedic

Swiss regulatory agency for therapeutic products.

MPA, Sweden

Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden.

NAFDAC, Nigeria

News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.

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