Pharmaceutical Regulatory Agencies and Organizations around the World

Major Regulatory Agencies around the World: 

Country	Name of  Regulatory Authority
USA	Food and Drug Administration (FDA)
UK	Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia	Therapeutic Goods Administration (TGA)
India	Central Drug Standard Control Organization (CDSCO)
Canada	Health Canada
Europe	European Medicines Agency (EMEA)
Denmark	Danish Medicines Agency
Costa Rica	Ministry of Health
New Zealand	Medsafe - Medicines and Medical Devices Safety Authority
Sweden	Medical Products Agency (MPA)
Netherlands	Medicines Evaluation Board
Ireland	Irish Medicines Board

ICH Guidelines- Multidisciplinary Guidelines

ICH Multidisciplinary Guidelines:

Revised ICH Multidisciplinary Guidelines are listed below:

M1 MedDRA Terminology 

MedDRA Medical Dictionary for Regulatory Activities

M2 Electronic Standards 

ESTRI Electronic Standards for the Transfer of Regulatory Information

M3 Nonclinical Safety Studies 

M3(R2) - Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 

M3(R2) Q&As R - Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 

ICH Guidelines- Efficacy Guidelines

ICH Efficacy Guidelines:

Revised ICH Efficacy Guidelines are listed below:

E1 Clinical Safety for Drugs used in Long-Term Treatment 

E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions

E2A - E2F Pharmacovigilance 

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports
E2B(R3) IWG Implementation: Electronic Transmission of Individual Case Safety Reports
E2C(R2) Periodic Benefit-Risk Evaluation Report
E2C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report
E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning
E2F Development Safety Update Report

ICH Guidelines- Safety Guidelines

ICH Safety Guidelines:

Revised ICH Safety Guidelines are listed below:

S1A - S1C Carcinogenicity Studies 

S1 Rodent Carcinogenicity Studies for Human Pharmaceuticals
S1A Need for Carcinogenicity Studies of Pharmaceuticals
S1B Testing for Carcinogenicity of Pharmaceuticals
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals

S2 Genotoxicity Studies 

S2(R1) Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use

ICH Guidelines- Quality Guidelines

ICH Quality Guidelines:

Revised ICH Quality Guidelines are listed below:

Q1A(R2) - Stability Testing of New Drug Substances and Products

Q1B - Stability Testing: Photostability Testing of New Drug Substances and Products

Q1C - Stability Testing for New Dosage Forms - Annex to the ICH Harmonised Tripartite Guideline on Stability Testing for New Drugs and Products

Q1D - Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

Q1E - Evaluation for Stability Data

Q1F - Stability Data Package for Registration Applications in Climatic Zones III and IV

Q2(R1) - Validation of Analytical Procedures: Text and Methodology

Q3A(R2) - Impurities In New Drug Substances

Q3B(R2) - Impurities in New Drug Products

Q3C(R5) - Impurities: Guideline for Residual Solvents

ICH Guidelines

ICH Guidelines

The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories:

1. Quality Guidelines: 

Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceuticalquality based on Good Manufacturing Practice (GMP) risk management.