Library
The reference documents regulatory practitioners return to, gathered in one place. Unlike the brief that moves on each week, these are organised as catalogues you can come back to at any time, each with a link to the official source.
Public material from regulators and expert bodies is checked and updated automatically every Monday — large changes or removals are reviewed by a person first.
ICH guideline catalogue
31topicsThe internationally harmonised guidelines adopted by FDA, EMA, and MFDS alike, organised by Quality (Q) and Multidisciplinary (M) topic.
MFDS guidance and notice archive
99itemsGuidance, guides, notices, and proposed rules published by MFDS. A cumulative list you can return to after a weekly brief has covered them.
EU GMP Guide (EudraLex Vol 4)
38itemsThe EU GMP Guide for medicinal products — the chapters of Parts I, II, and III and the Annexes, in structural order.
PIC/S GMP Guide
47itemsThe PIC/S GMP Guide (PE 009), its annexes, and related guidance documents.
WHO TRS annexes
46itemsSelected GMP and quality documents from the annexes of the WHO Expert Committee Technical Report Series (TRS).
FDA guidance documents
88itemsSelected FDA guidance documents on drug GMP and quality.
US Code of Federal Regulations, 21 CFR (GMP)
63sectionsThe text of the drug GMP sections of the US Code of Federal Regulations. Not guidance but the regulation itself — every section of Part 210 (general) and Part 211 (finished pharmaceuticals CGMP), section by section.
EMA GMP and quality guidelines
33itemsSelected GMP-related procedural and scientific guidelines and Q&As published by the European Medicines Agency (EMA).
MHRA GMP and GDP guidance
26itemsMHRA (UK) GMP and GDP compliance information sheets, inspection deficiency statistics, and guidance documents.
Health Canada GMP guides
26itemsHealth Canada's GMP guide documents (GUI series).
PMDA inspection findings (ORANGE Letter)
15itemsThe English editions of PMDA's GMP inspection findings (ORANGE Letter) and its GMP/GCTP annual reports.
