Drug Regulatory Agencies and GMP Guidelines Across the World:

What is a Regulatory Agency: 

A regulatory agency (regulatory body, regulator) or independent agency (independent regulatory agency) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity.

Functions of Drug Regulatory Agencies: 

The Food and Drug Administration and or Agencies are the part of Department of the Health and Human Services of the individual countries. For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health.

These agencies are responsible for protecting and promoting public health through the control and supervision of: Food Safety; Tobacco Products; Dietary Supplements; Prescription and over-the-counter pharmaceutical drugs (medicines); Vaccines; Biopharmaceuticals; Blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. 

List of Country Wise Drug Regulatory Agencies and GMP Guidelines for our ready reference and use: 

Country	Name of Regulatory Agency	Good Manufacturing Practices Guidelines
USA	US Food and Drug Administration (FDA)   https://www.fda.gov	21 CFR – Code of Federal Regulation   https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
UK	Medicines and Healthcare Products Regulatory Agency (MHRA)   https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency	MHRA GMDP Guidelines     https://www.gmp-compliance.org/guidelines/gmp-guidelines
Australia	Therapeutic Goods Administration (TGA)     https://www.tga.gov.au/	PIC/S Guide to Good Manufacturing Practice   https://www.tga.gov.au/publication/manufacturing-principles-medicinal-products
India	Central Drug Standard Control Organization (CDSCO)     https://cdsco.gov.in/opencms/opencms/en/Home/	Drugs and Cosmetics Act ,1940 and Rules, 1945 As amended up to the 31st December, 2016   https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/
Canada	Health Canada   https://www.canada.ca/en/health-canada.html	Good Manufacturing Practices Guide for Drug Products (GUI 0001)   https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html
Europe	European Medicines Agency (EMEA)   https://www.ema.europa.eu/en	EU GMP Guidelines   https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice   and   https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en
Denmark	Danish Medicines Agency   https://laegemiddelstyrelsen.dk/en/	Danish Executive Orders and EU Regulations   https://laegemiddelstyrelsen.dk/en/licensing/company-authorisations-and-registrations/manufacture-and-import-of-medicines-and-intermediates/gdp-and-gmp/
Costa Rica	Costa Rica Ministry of Health   https://www.ministeriodesalud.go.cr/	Legislation   https://www.ministeriodesalud.go.cr/index.php/biblioteca/legislacion
New Zealand	Medsafe - Medicines and Medical Devices Safety Authority     https://www.medsafe.govt.nz/	New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods https://www.medsafe.govt.nz/regulatory/Guideline/code.asp
Sweden	Swedish Medical Products Agency (MPA)   https://www.lakemedelsverket.se/en
Netherlands	Medicines Evaluation Board   https://www.cbg-meb.nl/	Marketing authorization of medicines for humans https://www.cbg-meb.nl/onderdelen/handelsvergunning-geneesmiddelen-voor-mensen
Ireland	Health Products Regulatory Authority / Irish Medicines Board   https://www.hpra.ie/	Inspections relating to manufacturers authorizations   http://www.hpra.ie/homepage/medicines/regulatory-information/manufacturers/inspections-relating-to-manufacturing-authorisations
Italy	Italian Medicines Agency   https://www.aifa.gov.it/en/web/guest/home	Inspections and Authorizations   https://www.aifa.gov.it/en/web/guest/ispezioni
Nigeria	National Agency for Food and Drug Administration and Control (NAFDAC)   https://www.nafdac.gov.ng/
Ukraine	Ministry of Health   https://en.moz.gov.ua/
Singapore	Centre for Pharmaceutical Administration Health Sciences Authority   https://www.hsa.gov.sg/
Hong Kong	Department of Health: Pharmaceutical Services   https://www.dh.gov.hk/english/useful/useful_registration/useful_registration.html
Paraguay	Ministry of Health   https://www.mspbs.gov.py/index.php
Thailand	Ministry of Public Health   http://www.moph.go.th/
China	State Food and Drug Administration   http://www.nmpa.gov.cn/
Germany	Federal Institute for Drugs and  Medical Devices   https://www.bfarm.de/EN/Home/_node.html
Malaysia	National Pharmaceutical Control Bureau, Ministry of Health   https://npra.gov.my/index.php/en/
Pakistan	Drugs Control Organization, Ministry of Health   https://www.dra.gov.pk/
South Africa	Medicines Control Council   https://www.sahpra.org.za/
Sri Lanka	SPC, Ministry of Health   https://www.spc.lk/
Switzerland	Swissmedic  , Swiss Agency for Therapeutic Products   https://www.swissmedic.ch/swissmedic/en/home.html#:~:text=Swissmedic%20is%20the%20national%20authorisation,of%20human%20and%20animal%20health.
Uganda	Ministry of Health   https://www.health.go.ug/
Brazil	Agencia Nacional de Vigiloncia Sanitaria (ANVISA )   https://www.gov.br/anvisa/pt-br/english	GMP     https://www.gov.br/anvisa/pt-br/english/regulation-of-companies
Japan	Ministry of Health, Labour & Welfare(MHLW)   https://www.mhlw.go.jp/english/	GMP     https://www.pmda.go.jp/english/review-services/gmp-qms-gctp/0001.html

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