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Regulatory Authorities & Guidelines Hub

Quick links to the regulators, ethics guidelines and data standards that clinical research in India and abroad depends on.

United States

US FDA

Clinical trials, IND/NDA regulations and 21 CFR Part 11

FDA Drugs

Global

ICH

ICH E6(R3) Good Clinical Practice and efficacy guidelines

ICH guidelines

Global

WHO

International Clinical Trials Registry Platform

WHO ICTRP

India

CDSCO

New Drugs and Clinical Trials Rules 2019 and the SUGAM portal

CDSCO

India

CTRI

Clinical Trials Registry – India

CTRI

India

ICMR

National Ethical Guidelines for Biomedical and Health Research

ICMR Bioethics unit & guidelines

India

DBT

Biosafety regulation and recombinant research

DBT biosafety IBKP portal

India

PvPI / IPC

Pharmacovigilance Programme of India and adverse-event reporting

IPC

India

Ministry of AYUSH

GCP guidance for trials of traditional medicine

AYUSH

Europe

EMA

EudraLex and the EU Clinical Trials Regulation

EMA

Australia

TGA

Australian regulatory guidelines

TGA

Japan

PMDA

Pharmaceuticals and medical devices regulation

PMDA

Canada

Health Canada

Guidance for clinical trials and drug submissions

Health Canada

Data standards

CDISC

SDTM, CDASH and SEND clinical data standards

CDISC

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