International Drugs Regulatory Bodies and Guidelines

International Drugs Regulatory Bodies and Guidelines are as follows-

1 WHO (Medicines) - WHO guidelines on medicines policy, intellectual property rights, financing and supply management, quality and safety, selection and rational use of medicines, technical co-operation and traditional medicines.
Website - www.who.int/medicines/en/
2 WHO sites - WHO guidelines on all areas relevant to health of people all over.
Website - www.who.int/entity/en/
3 ICH - International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy and related aspects for developing and registering new medicinal products in Europe, Japan and the United States
Website - www.ich.org/cache/compo/276-254-1.html
4 EMEA - European Medicines Agency (EMEA), a decentralised body of the European Union head quartered in London, prescribes guidelines for inspections and general reporting and all aspects of human and veterinary medicines in the European Union.
Website - www.ema.europa.eu/ema/
5 OECD - Organization for Economic Collaboration and Development including 30 member countries covers economic and social issues in areas of health care.
Website - www.oecd.org/index.html
6 US FDA - Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.
Website - www.fda.gov/
7 TGA - Specifications regulating medicines, medical devices, blood, tissues and chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.
Website - www.tga.gov.au/
8 WTO - News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations.
Website - www.wto.org/
9 South Africa - The department of Health, South Africa.
Website - www.doh.gov.za/
10 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.
Website - www.codexalimentarius.net/web/index_en.jsp
11 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.
Website - www.mhra.gov.uk/
12 Health Canada - Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.
Website - www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/index-eng.php
13 Thai FDA - Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.
Website - www.fda.moph.go.th/eng/index.stm
14 Medsafe,New Zealand - Medsafe, New Zealand Medicines and Medical Devices Safety Authority.
Website - www.medsafe.govt.nz/
15 DOH, Philippines - The Department of Health, Philippines.
Website - www.doh.gov.ph/
16 HSA, Singapore - Health Sciences Authority (HSA), the regulatory body of Singapore.
Website - www.hsa.gov.sg/content/hsa/en.html
17 NPCB, Malaysia - Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.
Website - www.bpfk.gov.my/
18 BfArM, Germany - Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany.
Website - www.bfarm.de/en/index.php
19 DGMP, Belgium - Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.
Website - afigp.fgov.be/New/EN/About%20DGMP/about%20DGMP.html
20 NAFDAC, Nigeria - News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.
Website - www.nafdacnigeria.org/
21 MPA, Sweden - Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden.
Website - www.lakemedelsverket.se/
22 SwissMedic - Swiss regulatory agency for therapeutic products.
Website - www.swissmedic.ch/?lang=2


Please login your account first to take Free Trial Test and join the Online Test Series.
If you are a new user, Please create your account, its free.