Global Pharmaceutical Regulatory Authorities and Guidelines Database

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Global Pharmaceutical Regulatory Authorities and Guidelines Database

This blog post provides a comprehensive listing of pharmaceutical regulatory authorities worldwide, including their official websites, guidelines pages, and key regulatory documents. All information is sourced from official regulatory authority websites.

Disclaimer: This document contains links to official regulatory authority websites. Users should verify all information directly from the respective regulatory authorities. Regulatory requirements and guidelines are subject to change.

North America

United States – U.S. Food and Drug Administration (FDA)

Official Websitehttps://www.fda.gov
Guidelines Pagehttps://www.fda.gov/regulatory-information/search-fda-guidance-documents
Regulatory BodyU.S. Food and Drug Administration (FDA)

Key Databases and Resources

  • FDA Guidance Documents Database: https://www.fda.gov/regulatory-information/search-fda-guidance-documents
  • Drugs@FDA Database: https://www.accessdata.fda.gov/scripts/cder/daf/
  • Orange Book (Approved Drug Products): https://www.accessdata.fda.gov/scripts/cder/ob/
  • FDA 510(k) Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
  • Code of Federal Regulations (21 CFR): https://www.ecfr.gov/cgi-bin/ECFR?page=browse

Key Guidelines and Regulations

  • ICH Guidelines adopted by FDA
  • Drug Development and Review Guidelines
  • Good Manufacturing Practice (GMP) Guidelines
  • Clinical Trials Guidance
  • Bioequivalence Guidance

Canada – Health Canada (HC)

Official Websitehttps://www.canada.ca/en/health-canada.html
Guidelines Pagehttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html
Regulatory BodyHealth Canada (HC)

Key Databases and Resources

  • Drug Product Database: https://health-products.canada.ca/dpd-bdpp/
  • Guidance Documents: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html
  • Notice of Compliance Database: https://health-products.canada.ca/noc-ac/
  • Clinical Trials Database: https://health-products.canada.ca/ctdb-bdec/

Key Guidelines and Regulations

  • ICH Guidelines Implementation
  • Food and Drugs Act and Regulations
  • Good Manufacturing Practices (GMP)
  • Risk Management Plans Guidance
  • New Drug Submission Guidelines

Mexico – Federal Commission for Protection Against Sanitary Risk (COFEPRIS)

Official Websitehttps://www.gob.mx/cofepris
Guidelines Pagehttps://www.gob.mx/cofepris/documentos/guias-y-lineamientos
Regulatory BodyFederal Commission for Protection Against Sanitary Risk (COFEPRIS)

Key Databases and Resources

  • COFEPRIS Guidelines Portal: https://www.gob.mx/cofepris/documentos/guias-y-lineamientos

Key Guidelines and Regulations

  • Mexican Pharmacopoeia
  • NOM Standards for Pharmaceuticals
  • Registration Requirements
  • GMP Standards

Europe

European Union – European Medicines Agency (EMA)

Official Websitehttps://www.ema.europa.eu
Guidelines Pagehttps://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines
Regulatory BodyEuropean Medicines Agency (EMA)

Key Databases and Resources

  • Scientific Guidelines: https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines
  • European Public Assessment Reports (EPAR): https://www.ema.europa.eu/en/medicines
  • EU Clinical Trials Register: https://www.clinicaltrialsregister.eu/
  • EudraVigilance (Adverse Reactions): https://www.adrreports.eu/en/index.html

Key Guidelines and Regulations

  • ICH Guidelines (Adopted)
  • EU GMP Guidelines (EudraLex Volume 4)
  • Clinical Trials Regulation (EU) 536/2014
  • Orphan Medicines Guidelines
  • Paediatric Investigation Plans

United Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA)

Official Websitehttps://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Guidelines Pagehttps://www.gov.uk/government/collections/mhra-guidance-and-publications
Regulatory BodyMedicines and Healthcare products Regulatory Agency (MHRA)

Key Databases and Resources

  • MHRA Guidance and Publications: https://www.gov.uk/government/collections/mhra-guidance-and-publications
  • UK Medicines Information: https://www.gov.uk/guidance/medicines-and-medical-devices-regulation-what-you-need-to-know

Key Guidelines and Regulations

  • ICH Guidelines
  • UK GMP Guidelines
  • Good Clinical Practice (GCP)
  • Post-Brexit Regulatory Framework

Switzerland – Swissmedic

Official Websitehttps://www.swissmedic.ch
Guidelines Pagehttps://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/marktueberwachung/legislation-and-regulations.html
Regulatory BodySwissmedic

Key Databases and Resources

  • Legislation and Regulations: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/marktueberwachung/legislation-and-regulations.html
  • Authorised Medicines: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/authorised-medicinal-products-with-new-active-substances.html

Key Guidelines and Regulations

  • ICH Guidelines
  • Swiss Therapeutic Products Act
  • GMP Guidelines

Asia-Pacific

Japan – Pharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare (MHLW)

Official Websitehttps://www.pmda.go.jp/english/index.html
Guidelines Pagehttps://www.pmda.go.jp/english/review-services/regulatory-info/0002.html
Regulatory BodyPharmaceuticals and Medical Devices Agency (PMDA) / Ministry of Health, Labour and Welfare (MHLW)

Key Databases and Resources

  • PMDA Regulatory Information: https://www.pmda.go.jp/english/review-services/regulatory-info/0002.html
  • Japanese Pharmacopoeia 18th Edition: https://www.pmda.go.jp/english/rs-sb-std/standards-development/jp/0029.html
  • PMDA Safety Information: https://www.pmda.go.jp/english/safety/info-services/drugs/medical-safety-information/0002.html

Key Guidelines and Regulations

  • Japanese Pharmacopoeia
  • Pharmaceutical and Medical Device Act
  • ICH Guidelines (Active Member)
  • GMP Guidelines (J-GMP)
  • Bioequivalence Guidelines

China – National Medical Products Administration (NMPA) – formerly CFDA

Official Websitehttps://www.nmpa.gov.cn
Guidelines Pagehttps://www.nmpa.gov.cn (Chinese language primarily)
Regulatory BodyNational Medical Products Administration (NMPA) – formerly CFDA

Key Databases and Resources

  • NMPA Portal: https://www.nmpa.gov.cn
  • Drug Registration Database: http://app1.nmpa.gov.cn/data_nmpa/face3/dir.html

Key Guidelines and Regulations

  • Drug Administration Law
  • ICH Guidelines (Adopted)
  • GMP Guidelines
  • Clinical Trial Guidelines

South Korea – Ministry of Food and Drug Safety (MFDS) – formerly KFDA

Official Websitehttps://www.mfds.go.kr/eng/index.do
Guidelines Pagehttps://www.mfds.go.kr/eng/index.do
Regulatory BodyMinistry of Food and Drug Safety (MFDS) – formerly KFDA

Key Databases and Resources

  • MFDS English Portal: https://www.mfds.go.kr/eng/index.do
  • Korean Pharmacopoeia: Available through MFDS
  • Clinical Trials Information: https://cris.nih.go.kr

Key Guidelines and Regulations

  • Pharmaceutical Affairs Act
  • Korean GMP (K-GMP)
  • ICH Guidelines
  • Bioequivalence Guidelines
  • Korean Pharmacopoeia 12th Edition

India – Central Drugs Standard Control Organisation (CDSCO)

Official Websitehttps://cdsco.gov.in
Guidelines Pagehttps://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Guidance-documents/
Regulatory BodyCentral Drugs Standard Control Organisation (CDSCO)

Key Databases and Resources

  • CDSCO Guidance Documents: https://cdsco.gov.in/opencms/opencms/en/Acts-and-rules/Guidance-documents/
  • CDSCO SUGAM Portal: https://cdsco.gov.in/opencms/opencms/en/CDSCO-SUGAM/
  • Clinical Trials Registry – India: http://ctri.nic.in

Key Guidelines and Regulations

  • Drugs and Cosmetics Act, 1940
  • New Drugs and Clinical Trials Rules, 2019
  • Schedule M (GMP Requirements)
  • Indian Pharmacopoeia
  • Bioavailability/Bioequivalence Guidelines

Singapore – Health Sciences Authority (HSA)

Official Websitehttps://www.hsa.gov.sg
Guidelines Pagehttps://www.hsa.gov.sg/therapeutic-products/register
Regulatory BodyHealth Sciences Authority (HSA)

Key Databases and Resources

  • Therapeutic Products Registration: https://www.hsa.gov.sg/therapeutic-products/register
  • HSA Guidelines: https://www.hsa.gov.sg/therapeutic-products/overview

Key Guidelines and Regulations

  • Health Products Act
  • ICH Guidelines
  • ASEAN Guidelines
  • GMP Guidelines

Australia – Therapeutic Goods Administration (TGA)

Official Websitehttps://www.tga.gov.au
Guidelines Pagehttps://www.tga.gov.au/resources
Regulatory BodyTherapeutic Goods Administration (TGA)

Key Databases and Resources

  • TGA Guidance and Resources: https://www.tga.gov.au/resources
  • Australian Register of Therapeutic Goods (ARTG): https://www.tga.gov.au/artg
  • TGA Learn Portal: https://www.tga.gov.au/tga-learn

Key Guidelines and Regulations

  • Therapeutic Goods Act 1989
  • ICH Guidelines
  • Australian Code of GMP
  • Labelling Requirements
  • Clinical Trials Guidelines

New Zealand – New Zealand Medicines and Medical Devices Safety Authority (Medsafe)

Official Websitehttps://www.medsafe.govt.nz
Guidelines Pagehttps://www.medsafe.govt.nz/regulatory/Guideline/Guideline.asp
Regulatory BodyNew Zealand Medicines and Medical Devices Safety Authority (Medsafe)

Key Databases and Resources

  • Medsafe Guidelines: https://www.medsafe.govt.nz/regulatory/Guideline/Guideline.asp
  • New Zealand Medicines and Medical Devices Database: https://medsafe.govt.nz/

Key Guidelines and Regulations

  • Medicines Act 1981
  • ICH Guidelines
  • GMP Guidelines

Taiwan – Taiwan Food and Drug Administration (TFDA)

Official Websitehttps://www.fda.gov.tw
Guidelines Pagehttps://www.fda.gov.tw/eng/siteListContent.aspx?sid=10584
Regulatory BodyTaiwan Food and Drug Administration (TFDA)

Key Databases and Resources

  • TFDA English Portal: https://www.fda.gov.tw/eng/index.aspx
  • Regulations and Guidelines: https://www.fda.gov.tw/eng/siteListContent.aspx?sid=10584

Key Guidelines and Regulations

  • Pharmaceutical Affairs Act
  • ICH Guidelines
  • Taiwan Pharmacopoeia
  • GMP Standards

Malaysia – National Pharmaceutical Regulatory Agency (NPRA)

Official Websitehttps://www.npra.gov.my
Guidelines Pagehttps://www.npra.gov.my/index.php/en/legislation-guidelines.html
Regulatory BodyNational Pharmaceutical Regulatory Agency (NPRA)

Key Databases and Resources

  • NPRA Guidelines: https://www.npra.gov.my/index.php/en/legislation-guidelines.html
  • QUEST Portal: https://portal.bpfk.gov.my/quest3plus/

Key Guidelines and Regulations

  • Drug Control Authority Guidelines
  • ASEAN Guidelines
  • GMP Guidelines

Thailand – Thailand Food and Drug Administration (Thai FDA)

Official Websitehttps://www.fda.moph.go.th
Guidelines Pagehttps://www.fda.moph.go.th/eng/
Regulatory BodyThailand Food and Drug Administration (Thai FDA)

Key Databases and Resources

  • Thai FDA Portal: https://www.fda.moph.go.th/eng/

Key Guidelines and Regulations

  • Drug Act B.E. 2510
  • ASEAN Guidelines
  • GMP Requirements

Indonesia – National Agency of Drug and Food Control (BPOM)

Official Websitehttps://www.pom.go.id
Guidelines Pagehttps://www.pom.go.id/new/view/more/peraturan/
Regulatory BodyNational Agency of Drug and Food Control (BPOM)

Key Databases and Resources

  • BPOM Regulations: https://www.pom.go.id/new/view/more/peraturan/

Key Guidelines and Regulations

  • Indonesian Pharmacopoeia
  • ASEAN Guidelines
  • GMP Standards

Philippines – Food and Drug Administration Philippines (FDA Philippines)

Official Websitehttps://www.fda.gov.ph
Guidelines Pagehttps://www.fda.gov.ph/guidelines-and-issuances/
Regulatory BodyFood and Drug Administration Philippines (FDA Philippines)

Key Databases and Resources

  • FDA Philippines Guidelines: https://www.fda.gov.ph/guidelines-and-issuances/

Key Guidelines and Regulations

  • Republic Act No. 9711 (FDA Act)
  • ASEAN Guidelines
  • GMP Standards

Vietnam – Drug Administration of Vietnam (DAV)

Official Websitehttp://dav.gov.vn
Guidelines Pagehttp://dav.gov.vn (Vietnamese language)
Regulatory BodyDrug Administration of Vietnam (DAV)

Key Databases and Resources

  • DAV Portal: http://dav.gov.vn

Key Guidelines and Regulations

  • Vietnamese Pharmacy Law
  • ASEAN Guidelines
  • GMP Standards

Middle East

Saudi Arabia – Saudi Food and Drug Authority (SFDA)

Official Websitehttps://www.sfda.gov.sa
Guidelines Pagehttps://www.sfda.gov.sa/en/regulations
Regulatory BodySaudi Food and Drug Authority (SFDA)

Key Databases and Resources

  • SFDA Regulations: https://www.sfda.gov.sa/en/regulations
  • GHAD Portal (Electronic Submissions): https://ghad.sfda.gov.sa

Key Guidelines and Regulations

  • SFDA Law
  • ICH Guidelines (Aligned)
  • WHO Maturity Level 4 Status
  • Drug Pricing Regulations
  • GMP Requirements

United Arab Emirates – UAE Ministry of Health (MOH)

Official Websitehttps://www.mohap.gov.ae
Guidelines Pagehttps://www.mohap.gov.ae/en/services
Regulatory BodyUAE Ministry of Health (MOH)

Key Databases and Resources

  • MOH Services Portal: https://www.mohap.gov.ae/en/services

Key Guidelines and Regulations

  • UAE Drug Registration Requirements
  • GCC Guidelines
  • GMP Standards

Kuwait – Kuwait Food and Drug Authority (KuFDA)

Official Websitehttps://www.kfda.gov.kw
Guidelines PageContact Authority directly
Regulatory BodyKuwait Food and Drug Authority (KuFDA)

Key Databases and Resources

  • KuFDA Portal: https://www.kfda.gov.kw

Key Guidelines and Regulations

  • Kuwait Drug Registration
  • GCC Guidelines

Bahrain – National Health Regulatory Authority (NHRA)

Official Websitehttps://www.nhra.bh
Guidelines Pagehttps://www.nhra.bh/en/Sections/drugctrl
Regulatory BodyNational Health Regulatory Authority (NHRA)

Key Databases and Resources

  • NHRA Drug Control: https://www.nhra.bh/en/Sections/drugctrl

Key Guidelines and Regulations

  • Bahrain Drug Regulations
  • GCC Guidelines

Qatar – Pharmacy and Drug Control – Ministry of Public Health

Official Websitehttps://www.moph.gov.qa
Guidelines PageContact Authority directly
Regulatory BodyPharmacy and Drug Control – Ministry of Public Health

Key Databases and Resources

  • MOPH Portal: https://www.moph.gov.qa

Key Guidelines and Regulations

  • Qatar Drug Regulations
  • GCC Guidelines

Oman – Directorate General of Pharmaceutical Affairs and Drug Control

Official Websitehttps://www.moh.gov.om
Guidelines Pagehttps://www.moh.gov.om/en/
Regulatory BodyDirectorate General of Pharmaceutical Affairs and Drug Control

Key Databases and Resources

  • MOH Oman: https://www.moh.gov.om/en/

Key Guidelines and Regulations

  • Oman Drug Regulations
  • GCC Guidelines

Jordan – Jordan Food and Drug Administration (JFDA)

Official Websitehttps://www.jfda.jo
Guidelines Pagehttps://www.jfda.jo/EchoBusV3.0/SystemAssets/PDFs.aspx
Regulatory BodyJordan Food and Drug Administration (JFDA)

Key Databases and Resources

  • JFDA Guidelines: https://www.jfda.jo/EchoBusV3.0/SystemAssets/PDFs.aspx

Key Guidelines and Regulations

  • Jordan Drug Act
  • Registration Requirements

Israel – Ministry of Health – Pharmaceutical Division

Official Websitehttps://www.health.gov.il
Guidelines Pagehttps://www.health.gov.il/English/Topics/Pregnancy/Pharma_pregnancy/Pages/default.aspx
Regulatory BodyMinistry of Health – Pharmaceutical Division

Key Databases and Resources

  • MOH Israel Portal: https://www.health.gov.il/English/

Key Guidelines and Regulations

  • Israeli Pharmaceutical Regulations
  • Drug Registration Requirements

Turkey – Turkish Medicines and Medical Devices Agency (TITCK)

Official Websitehttps://www.titck.gov.tr
Guidelines Pagehttps://www.titck.gov.tr/mevzuat
Regulatory BodyTurkish Medicines and Medical Devices Agency (TITCK)

Key Databases and Resources

  • TITCK Legislation: https://www.titck.gov.tr/mevzuat

Key Guidelines and Regulations

  • Turkish Medicinal Products Law
  • GMP Guidelines

Iran – Iran Food and Drug Administration (IFDA)

Official Websitehttps://www.fda.gov.ir
Guidelines PageContact Authority directly
Regulatory BodyIran Food and Drug Administration (IFDA)

Key Databases and Resources

  • IFDA Portal: https://www.fda.gov.ir

Key Guidelines and Regulations

  • Iranian Drug Regulations

Egypt – Egyptian Drug Authority (EDA)

Official Websitehttps://www.edaegypt.gov.eg
Guidelines Pagehttps://www.edaegypt.gov.eg/media/
Regulatory BodyEgyptian Drug Authority (EDA)

Key Databases and Resources

  • EDA Media Center: https://www.edaegypt.gov.eg/media/
  • WHO Guidelines Adopted: https://www.edaegypt.gov.eg

Key Guidelines and Regulations

  • Egyptian Pharmaceutical Law
  • WHO Norms and Standards (Adopted)
  • GMP Guidelines

South America

Brazil – Brazilian Health Surveillance Agency (ANVISA)

Official Websitehttps://www.gov.br/anvisa
Guidelines Pagehttps://www.gov.br/anvisa/pt-br/english/regulation-of-products/drugs
Regulatory BodyBrazilian Health Surveillance Agency (ANVISA)

Key Databases and Resources

  • ANVISA Drug Regulations: https://www.gov.br/anvisa/pt-br/english/regulation-of-products/drugs
  • ANVISA Regulations Database: https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao

Key Guidelines and Regulations

  • Resolution RDC 753/2023 (New Drugs, Generics, Similar)
  • Resolution RDC 945/2024 (Clinical Trials)
  • Law 6360/1973 (Marketing Authorization)
  • ICH Guidelines (Aligned)
  • Real-World Evidence Guidelines

Argentina – National Administration of Drugs, Foods and Medical Devices (ANMAT)

Official Websitehttps://www.argentina.gob.ar/anmat
Guidelines Pagehttps://www.argentina.gob.ar/anmat/regulados/medicamentos/normativa
Regulatory BodyNational Administration of Drugs, Foods and Medical Devices (ANMAT)

Key Databases and Resources

  • ANMAT Regulations: https://www.argentina.gob.ar/anmat/regulados/medicamentos/normativa

Key Guidelines and Regulations

  • Argentine Pharmacopoeia
  • Drug Registration Requirements
  • GMP Guidelines

Chile – Public Health Institute of Chile (ISPCH)

Official Websitehttps://www.ispch.cl
Guidelines Pagehttps://www.ispch.cl/normativa/
Regulatory BodyPublic Health Institute of Chile (ISPCH)

Key Databases and Resources

  • ISPCH Regulations: https://www.ispch.cl/normativa/

Key Guidelines and Regulations

  • Chilean Pharmaceutical Regulations
  • Drug Registration Requirements

Colombia – National Food and Drug Surveillance Institute (INVIMA)

Official Websitehttps://www.invima.gov.co
Guidelines Pagehttps://www.invima.gov.co/guias-invima
Regulatory BodyNational Food and Drug Surveillance Institute (INVIMA)

Key Databases and Resources

  • INVIMA Guidelines: https://www.invima.gov.co/guias-invima

Key Guidelines and Regulations

  • Colombian Pharmaceutical Regulations
  • Drug Registration Requirements

Peru – General Directorate of Medicines, Supplies and Drugs (DIGEMID)

Official Websitehttp://www.digemid.minsa.gob.pe
Guidelines Pagehttp://www.digemid.minsa.gob.pe/Main.asp?Seccion=813
Regulatory BodyGeneral Directorate of Medicines, Supplies and Drugs (DIGEMID)

Key Databases and Resources

  • DIGEMID Regulations: http://www.digemid.minsa.gob.pe/Main.asp?Seccion=813

Key Guidelines and Regulations

  • Peruvian Drug Law
  • Registration Requirements

Ecuador – National Agency for Regulation, Control and Sanitary Surveillance (ARCSA)

Official Websitehttps://www.controlsanitario.gob.ec
Guidelines Pagehttps://www.controlsanitario.gob.ec/normativa/
Regulatory BodyNational Agency for Regulation, Control and Sanitary Surveillance (ARCSA)

Key Databases and Resources

  • ARCSA Regulations: https://www.controlsanitario.gob.ec/normativa/

Key Guidelines and Regulations

  • Ecuadorian Health Code
  • Drug Registration Requirements

Africa

South Africa – South African Health Products Regulatory Authority (SAHPRA)

Official Websitehttps://www.sahpra.org.za
Guidelines Pagehttps://www.sahpra.org.za/guidelines/
Regulatory BodySouth African Health Products Regulatory Authority (SAHPRA)

Key Databases and Resources

  • SAHPRA Guidelines: https://www.sahpra.org.za/guidelines/
  • SAHPRA e-Submission Portal (eCTD): https://www.sahpra.org.za
  • General Regulations: https://www.sahpra.org.za/document/general-regulations/

Key Guidelines and Regulations

  • Medicines and Related Substances Act, 1965 (Act 101)
  • Risk-Based Assessment Approach
  • ICH Guidelines (Aligned)
  • eCTD Submission Format
  • Clinical Trial Regulations

Nigeria – National Agency for Food and Drug Administration and Control (NAFDAC)

Official Websitehttps://www.nafdac.gov.ng
Guidelines Pagehttps://www.nafdac.gov.ng/resources/guidelines/
Regulatory BodyNational Agency for Food and Drug Administration and Control (NAFDAC)

Key Databases and Resources

  • NAFDAC Guidelines: https://www.nafdac.gov.ng/resources/guidelines/

Key Guidelines and Regulations

  • NAFDAC Act
  • Drug Registration Requirements
  • GMP Guidelines

Kenya – Pharmacy and Poisons Board (PPB)

Official Websitehttps://pharmacyboardkenya.org
Guidelines Pagehttps://pharmacyboardkenya.org/guidelines/
Regulatory BodyPharmacy and Poisons Board (PPB)

Key Databases and Resources

  • PPB Guidelines: https://pharmacyboardkenya.org/guidelines/

Key Guidelines and Regulations

  • Kenyan Pharmacy and Poisons Act
  • Drug Registration Guidelines

Ghana – Food and Drugs Authority Ghana (FDA Ghana)

Official Websitehttps://www.fdaghana.gov.gh
Guidelines Pagehttps://www.fdaghana.gov.gh/resources.php
Regulatory BodyFood and Drugs Authority Ghana (FDA Ghana)

Key Databases and Resources

  • FDA Ghana Resources: https://www.fdaghana.gov.gh/resources.php

Key Guidelines and Regulations

  • Public Health Act, 2012
  • Drug Registration Guidelines

Zimbabwe – Medicines Control Authority of Zimbabwe (MCAZ)

Official Websitehttps://www.mcaz.co.zw
Guidelines Pagehttps://www.mcaz.co.zw/index.php/guidelines
Regulatory BodyMedicines Control Authority of Zimbabwe (MCAZ)

Key Databases and Resources

  • MCAZ Guidelines: https://www.mcaz.co.zw/index.php/guidelines

Key Guidelines and Regulations

  • Medicines and Allied Substances Control Act
  • Drug Registration Guidelines

South Asia

Pakistan – Drug Regulatory Authority of Pakistan (DRAP)

Official Websitehttps://www.dra.gov.pk
Guidelines Pagehttps://www.dra.gov.pk/guidelines/
Regulatory BodyDrug Regulatory Authority of Pakistan (DRAP)

Key Databases and Resources

  • DRAP Guidelines: https://www.dra.gov.pk/guidelines/

Key Guidelines and Regulations

  • Drugs Act 1976
  • Drug Registration Requirements

Bangladesh – Directorate General of Drug Administration (DGDA)

Official Websitehttps://www.dgda.gov.bd
Guidelines Pagehttps://www.dgda.gov.bd/index.php/laws-and-rules
Regulatory BodyDirectorate General of Drug Administration (DGDA)

Key Databases and Resources

  • DGDA Laws and Rules: https://www.dgda.gov.bd/index.php/laws-and-rules

Key Guidelines and Regulations

  • Drugs Act 1940
  • Drug Registration Requirements

Sri Lanka – National Medicines Regulatory Authority (NMRA)

Official Websitehttp://www.nmra.gov.lk
Guidelines Pagehttp://www.nmra.gov.lk/index.php?option=com_content&view=article&id=93
Regulatory BodyNational Medicines Regulatory Authority (NMRA)

Key Databases and Resources

  • NMRA Guidelines: http://www.nmra.gov.lk

Key Guidelines and Regulations

  • National Medicines Regulatory Authority Act
  • Drug Registration Guidelines

Nepal – Department of Drug Administration (DDA)

Official Websitehttp://www.dda.gov.np
Guidelines Pagehttp://www.dda.gov.np/content/acts-and-regulations
Regulatory BodyDepartment of Drug Administration (DDA)

Key Databases and Resources

  • DDA Acts and Regulations: http://www.dda.gov.np/content/acts-and-regulations

Key Guidelines and Regulations

  • Drug Act 1978
  • Drug Registration Requirements

International Organizations

Global – World Health Organization (WHO)

Official Websitehttps://www.who.int
Guidelines Pagehttps://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines
Regulatory BodyWorld Health Organization (WHO)

Key Databases and Resources

  • WHO Pharmaceutical Guidelines: https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/guidelines
  • WHO Technical Report Series: https://www.who.int/publications
  • WHO Prequalification Programme: https://extranet.who.int/prequal/
  • WHO Listed Authorities (WLA): https://www.who.int/teams/regulation-prequalification/regulation-and-safety/wla

Key Guidelines and Regulations

  • WHO Good Manufacturing Practices (GMP)
  • Quality Assurance of Pharmaceuticals (Compendium)
  • Guidelines for Registration of Fixed-Dose Combinations
  • Stability Testing Guidelines
  • Bioequivalence Guidelines
  • Clinical Trials Guidelines
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Pharmacovigilance Guidelines

Global – International Council for Harmonisation (ICH)

Official Websitehttps://www.ich.org
Guidelines Pagehttps://www.ich.org/page/ich-guidelines
Regulatory BodyInternational Council for Harmonisation (ICH)

Key Databases and Resources

  • ICH Quality Guidelines: https://www.ich.org/page/quality-guidelines
  • ICH Safety Guidelines: https://www.ich.org/page/safety-guidelines
  • ICH Efficacy Guidelines: https://www.ich.org/page/efficacy-guidelines
  • ICH Multidisciplinary Guidelines: https://www.ich.org/page/multidisciplinary-guidelines

Key Guidelines and Regulations

  • Q1-Q14: Quality Guidelines (Stability, Impurities, GMP, etc.)
  • S1-S12: Safety Guidelines (Carcinogenicity, Genotoxicity, etc.)
  • E1-E20: Efficacy Guidelines (Clinical Studies, Pharmacovigilance)
  • M1-M13: Multidisciplinary Guidelines (CTD, eCTD, Medical Terminology)

Global – Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Official Websitehttps://www.picscheme.org
Guidelines Pagehttps://www.picscheme.org/en/publications
Regulatory BodyPharmaceutical Inspection Co-operation Scheme (PIC/S)

Key Databases and Resources

  • PIC/S Guidelines: https://www.picscheme.org/en/publications

Key Guidelines and Regulations

  • PIC/S GMP Guide (PE 009)
  • Guide to Good Manufacturing Practice for Medicinal Products
  • Annexes (Sterile Products, APIs, etc.)

Important Notes and Instructions

  1. All URLs provided are from official regulatory authority websites. Please verify links periodically as they may change.
  2. Many regulatory authorities publish guidelines in their local language. English versions may not be available for all documents.
  3. For the most current guidelines, always check the official regulatory authority website directly.
  4. Some authorities require registration or login to access certain documents and databases.
  5. ICH guidelines are adopted by many regulatory authorities worldwide. Check the ICH website (https://www.ich.org) for the most current versions.
  6. WHO guidelines serve as international reference standards and are adopted by many national regulatory authorities.
  7. For countries not listed or for additional specific guidance, contact the respective regulatory authority directly.
  8. eCTD (Electronic Common Technical Document) format is increasingly required for submissions globally.
  9. Many authorities are members of international collaboration initiatives (ICH, PIC/S, WHO Listed Authorities) which promote harmonization.
  10. Regulatory requirements frequently change. Subscribe to regulatory authority newsletters and updates for the latest information.

Additional Resources

GMP Compliance Database
URL: https://www.gmp-compliance.org/guidelines/gmp-guidelines
Description: Comprehensive database of GMP guidelines from EU/EMA, FDA, ICH, PIC/S, WHO and industry interpretations (over 1,200 guidelines)

ICMRA (International Coalition of Medicines Regulatory Authorities)
URL: https://icmra.info
Description: Network of regulatory authorities from around the world promoting strategic coordination and leadership

Regulatory Affairs Professionals Society (RAPS)
URL: https://www.raps.org
Description: Professional association providing regulatory resources and information

DIA (Drug Information Association)
URL: https://www.diaglobal.org
Description: Global association providing neutral forum for knowledge exchange in product development

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