Every regulatory body a GxP practitioner is cited against.
SPEQ decodes the sources that govern regulated industry worldwide — national regulators, international harmonizers, compendia, and standards bodies. Open any one for its mandate, how its requirements acquire force, and what practitioners get wrong about it.
How to use this library
Start with what a body IS — a regulator issues law, a compendium publishes text someone else enforces. Then narrow by where it holds jurisdiction. Each row opens the body’s own page: its mandate, how its requirements acquire force, and what practitioners get wrong about it.
SPEQ curates and cross-references these bodies. It is not affiliated with, accredited by, or endorsed by any of them, and a count of decoded standards is a measure of SPEQ’s coverage, not of a body’s importance.
COMPLETE INDEX — ALL 48 REGULATORY BODY
Every count on this page is derived at render from src/data/regulatory-bodies.ts and the standards mapped to each body — none is a literal. Follow each official-source link for authoritative text.
GxP regulators, region by region
Where each body holds jurisdiction, and which frameworks it issues. Open a region to filter the catalog above to it.
North America7 bodies
The United States (FDA, 21 CFR, and the USP compendia) and Canada (Health Canada, GUI-0001) — the market whose cGMP and data-integrity expectations set the global reference point.
Filter to North America →Europe5 bodies
The EU framework (EMA and the European Commission’s EudraLex Volume 4 — the EU GMP Guide and its Annexes), the post-Brexit UK (MHRA), and Switzerland (Swissmedic) — GMP, GDP, and GVP across the EEA and its trading partners.
Filter to Europe →Asia-Pacific11 bodies
Australia (TGA), Japan (PMDA), China (NMPA), India (CDSCO), and South Korea (MFDS) — a mix of ICH members and PIC/S participants applying national GMP codes to the world’s largest manufacturing base.
Filter to Asia-Pacific →Latin America6 bodies
Brazil’s ANVISA — the region’s reference regulator, an ICH member issuing GMP through its RDC resolutions.
Filter to Latin America →Middle East & Africa2 bodies
Saudi Arabia (SFDA, the first Arab member of PIC/S) and South Africa (SAHPRA, a PIC/S member since 2007 and WHO Maturity Level 3) — the reference regulators for the Gulf and sub-Saharan markets, both anchoring GMP to the PIC/S standard.
Filter to Middle East & Africa →International17 bodies
The bodies that harmonize across borders — ICH (Q/E/M series), WHO (TRS), PIC/S (PE 009 inspection standard), Codex and VICH (food and veterinary), and the standards and compendia (ISO, IEC, OECD GLP, USP) — plus the industry societies (ISPE, PDA) whose guides are de-facto references.
Filter to International →SPEQ curates and cross-references these bodies; it is not affiliated with or endorsed by any of them. Follow each official-source link for authoritative text.