Introducing Regulatory Intelligence in Sofie

Regulatory information shapes decisions across development, quality, supply, and compliance. Yet teams still search across multiple regulator websites, compare requirements market by market, and piece together the evidence behind recalls, shortages, inspection outcomes, and revised guidance. The information changes constantly, but the conclusions must remain current, traceable, and ready to support change controls, audit responses, submissions, and risk assessments.

Today we’re announcing Sofie Regulatory Intelligence: a continuously updated, fully sourced knowledge base of official pharmaceutical regulations, guidance, publications, and regulator records from eight regulators and standards bodies: the FDA, Health Canada, the EU and EMA, ICH, PIC/S, WHO, TGA, and Japan’s PMDA and MHLW.

Research Current Requirements

The library contains approximately 16,000 official documents, 218,000 searchable passages, and 177,000 structured regulatory records. It brings together regulations, guidance, approvals, recalls, enforcement actions, shortages, Health Canada inspection outcomes, safety assessments, FDA warning letters and compliance programs, Federal Register notices, PMDA review reports, and other regulator publications. Coverage is limited to human drugs and biologics, using English-language sources.

Every supported answer traces to an official source, with the source URL, publication status, relevant dates, and page or section. Sofie retains an archived copy of every original; that link is shown when an official URL is unavailable. When evidence is missing, Sofie identifies the gap rather than filling it from memory.

Compare Across Regulators

Regulatory Intelligence compares requirements and expectations across authorities using evidence from each named regulator. Its requirements graph connects hundreds of thousands of individual extracted requirements with verified cross-authority relationships, version history, and company and site profiles. Teams can also read long regulations systematically by page, section, or document outline and verify which sources and records are available before drawing a conclusion.

Operate With Market-Wide Visibility

Many teams can answer, “What does this guidance say?” Fewer can quickly answer, “What is happening across markets that could affect this product, facility, or program?” Regulatory Intelligence lets teams count and trend recalls, shortages, approvals, Health Canada inspection outcomes, and safety activity; profile a drug, company, or facility across markets; and look up identifiers such as NDA, ANDA, NDC, DIN, and recall numbers.

Monitor Change and Trigger Action

Recall, shortage, enforcement, and safety feeds are checked every six hours; approvals, product registers, and other catalogs every twelve hours. Sofie re-checks every authority at least daily and flags a missed check, while quality gates prevent incomplete updates from replacing validated content. Sofie tracks whether each authority’s feed is current and can tell users what it does and does not cover.

Each refresh records material that was added, revised, withdrawn, or removed, including before-and-after copies. Teams can manually run a Regulatory Change Review orchestration to compile relevant changes, support impact review, recommend the appropriate owner, and prepare draft communications for review. Each change also receives an automatic materiality assessment to distinguish substantive changes from date-only updates.

Designed for Traceable Review

Regulatory Intelligence helps regulatory affairs, quality, and supply teams work from primary records rather than general web search or model memory. Coverage varies by authority and source type: Health Canada guidance remains limited. TGA’s full product register is not yet included because TGA does not provide a machine-readable export, and FDA inspection classifications are not included because they require agency-issued access. Historical change tracking begins with the launch of the change ledger.

Sofie summarizes the available evidence and does not provide legal or regulatory advice. Draft and withdrawn materials are excluded unless explicitly requested. By bringing official sources, structured data, monitoring, and downstream action together, Regulatory Intelligence helps teams spend less time finding information and more time determining what it means for their work.

Already using Sofie? Ask us how regulatory intelligence can support your next regulatory review. If you're new to Sofie and want to see regulatory intelligence in action, request a 1:1. Regulatory intelligence is now available in beta within Sofie.