Coverage
The regulatory corpus Preclari draws on: every source in the corpus today, the sources on the roadmap, and the jurisdictions and domains not yet covered. If your jurisdiction or domain isn't listed here, tell us. A new source goes into the corpus only after a recorded review of it passes. Public jurisdiction additions enter the shared corpus snapshot once they pass that review. Your workflow data does not.
Curated. No crawling.
Covered today
in the corpus nowRoadmap
trigger-gated · by demand signalICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
Unlocks: API manufacturing AI workflows (deviation, OOS, change control)
FDA Draft Guidance, Considerations for the Use of Artificial Intelligence and Machine Learning in Drug Manufacturing AI-specific context
Unlocks: AI-specific GMP context for US workflows
Not yet covered
tell us if you need itJapan, PMDA
Pharmaceuticals and Medical Devices Agency guidance not yet onboarded; translation and structural alignment required.
Tell us if: Your workflow touches Japanese market authorisations or PMDA-inspected sites.
China, NMPA
National Medical Products Administration guidance not yet onboarded; corpus requires NMPA-specific document curation.
Tell us if: Your workflow operates in or imports to mainland China and is regulated by NMPA.
India, CDSCO
Central Drugs Standard Control Organisation guidance not yet onboarded.
Tell us if: Your workflow involves CDSCO-regulated manufacturing or distribution.
Brazil, ANVISA
Agência Nacional de Vigilância Sanitária guidance not yet onboarded.
Tell us if: Your workflow operates under ANVISA jurisdiction.
Korea, MFDS
Ministry of Food and Drug Safety guidance not yet onboarded.
Tell us if: Your workflow involves Korean market authorisation or MFDS-inspected sites.
GCP and GLP, extended coverage
Tier-1 pharma R&D anchors are now onboarded: ICH E6(R3) GCP (ich-e6-r3-gcp) and FDA 21 CFR Part 58 GLP (fda-21cfr-58-glp). Still NOT covered: ICH E8(R1)/E9 (general clinical-study and statistical principles), EU Clinical Trials Regulation 536/2014, and FDA 21 CFR Part 312 (IND), adjacent clinical sources deferred to a later R&D tranche.
Tell us if: Your workflow needs ICH E8/E9, EU CTR 536/2014, or FDA Part 312 (IND) coverage beyond the onboarded GCP and GLP anchors.
OECD Principles of Good Laboratory Practice (Series No. 1)
Reference-only. The OECD GLP document's controlling copyright notice requires written permission for reproduction (and the 1998 document predates OECD's post-2024 CC BY 4.0 default), so its text is NOT reproduced under the B-3 verbatim gate. GLP requirements are carried verbatim by the US public-domain equivalent, FDA 21 CFR Part 58 (fda-21cfr-58-glp); OECD GLP is cited as a cross-reference only.
Tell us if: Your workflow specifically requires verbatim OECD GLP No. 1 clause text rather than the FDA Part 58 GLP equivalent.
Veterinary medicines
Veterinary GMP and EMA/CVMP veterinary medicines guidance are not yet onboarded. They differ enough from human-pharma GMP to warrant a separate corpus.
Tell us if: Your workflow is veterinary-pharma rather than human-pharma.
Switzerland, IvDV (In-vitro-Diagnostika-Verordnung, SR 812.219)
Swiss IVD ordinance (Switzerland's parallel to EU IVDR 2017/746) not yet onboarded. IvDV requires separate extraction under the same verbatim gate.
Tell us if: Your workflow involves Swiss in-vitro diagnostic devices regulated under IvDV.
IMDRF, MDSAP audit criteria
Medical Device Single Audit Program (MDSAP) audit approach and task descriptions (IMDRF/MDSAP WG/N9 and related documents) not yet extracted. MDSAP covers manufacturers in AU/BR/CA/JP/US.
Tell us if: Your workflow involves MDSAP audit readiness or single-audit participation.
Need a jurisdiction or domain not yet on this page?
If your workflow touches a jurisdiction, regulator, or GxP domain that isn't visible here yet,