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CLINOVITAS LIFESCIENCES / REGULATORY HUB

Global Regulatory
Authorities & Guidelines Hub.

A curated directory of high-authority regulatory, ethical, clinical trial and data standards resources.

UNITED STATES

US FDA

Clinical Trials, IND/NDA Regulations & 21 CFR Part 11

Official FDA Drugs Resource →
GLOBAL

ICH-GCP

Integrated Addendum to ICH E6(R2/R3) Good Clinical Practice

Official ICH Resource →
GLOBAL

WHO

Clinical Trial Registry Network & Standards

Official WHO Resource →
INDIA

CDSCO

NDCT Rules 2019 & Sugam Portal

Official CDSCO →
INDIA

ICMR

National Ethical Guidelines for Biomedical & Health Research

Official ICMR →
EUROPE

EMA

EudraLex & Clinical Trial Regulation (EU CTR)

Official EMA →
AUSTRALIA

TGA

Australian Regulatory Guidelines

Official TGA →
JAPAN

PMDA / MHLW

Pharmaceuticals and Medical Devices clinical regulations

Official PMDA →
CANADA

Health Canada

Guidance for Clinical Trials & Drug Submissions

Official Health Canada →
DATA STANDARDS

CDISC

SDTM / CDASH / SEND clinical data standards

Official CDISC →
INDIA

PvPI / IPC

Pharmacovigilance Programme of India & adverse event reporting

Official IPC →
INDIA

AYUSH

GCP guidance for traditional medicine trials

Official AYUSH →
INDIA

DBT

Biosafety regulations & recombinant research

Official DBT →
ANALYTICS

IBM SPSS Statistics

Advanced inferential biostatistics & predictive analytics

Official IBM SPSS →