SPEQ decodes the sources that govern regulated industry worldwide — national regulators, international harmonizers, compendia, and standards bodies. Select any to see what SPEQ maps from it.
Every regulator, harmonizer, compendium, and standards body SPEQ decodes, grouped by where it holds jurisdiction. Follow any regulator to the standards SPEQ maps to it.
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.
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.
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.
Brazil’s ANVISA — the region’s reference regulator, an ICH member issuing GMP through its RDC resolutions.
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.
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.