§ 03 — THE LIBRARY
One standard. Six agencies.
One library.
A curated, free repository of the regulations, inspection programs, guidance, Q&As, templates and reflection papers that govern sponsor-side GCP.
§ 01 — Doctrine
INTL ICH
International Council for Harmonisation
The standard the national authorities adopt. E6(R3), E8(R1), and the
reflection papers that sit upstream of every enforcement programme below.
11
documents
§ 02 — Agencies
US
FDA
U.S. Food & Drug Administration
BIMO · CDER · CBER
17 docs
EU
EMA
European Medicines Agency
GCP Inspectors Working Group
18 docs
UK
MHRA
Medicines & Healthcare products Regulatory Agency
GCP Inspectorate
11 docs
JP
PMDA
Pharmaceuticals & Medical Devices Agency
Office of Conformity Audit
6 docs
CA
HC
Health Canada
Regulatory Operations
3 docs
CN
NMPA
National Medical Products Administration
Centre for Drug Evaluation
11 docs
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77 documents