Global life sciences manufacturing is increasingly distributed across regions, suppliers, and regulatory jurisdictions. For quality and regulatory teams, that creates a practical challenge: inspection and compliance signals exist across many agencies—but they are difficult to use consistently because they are fragmented, unstructured, and not readily comparable.

Redica converts fragmented inspection and enforcement data into connected intelligence that supports global oversight, supplier qualification, and risk-based decision-making.

With new data sets from Japan PMDA, Swissmedic, expanded EMA GDP coverage, and Korea MFDS, Redica delivers the industry’s most comprehensive and harmonized view of global GMP and GDP inspection activity. This expansion brings customers greater clarity to regulatory pressure, supplier risk, and compliance maturity across Asia and Europe.

Why Global Inspection Data Still Falls Short

Most quality and regulatory teams face the same challenge: the information exists, but it’s nearly impossible to use at scale.

Some regulators publish only high-level summaries. Others bury critical findings in PDFs or country-specific portals. Many release documents exclusively in local languages. Terminology and categorizations for inspection types, outcomes, and findings vary across regulators and cross-agency comparisons are often manual, slow, and difficult to validate.

The result is blind spots, especially when teams need to monitor multi-tier supplier networks, spot emerging compliance concerns early, or maintain consistent global oversight.

At Redica, we go beyond collecting documents, focusing on structuring, normalizing, enriching, and connecting inspection intelligence so customers can understand regulatory risk in context, across regions, and before issues escalate.

What’s New in Redica’s Global Inspection Coverage

This launch significantly expands both the breadth and depth of Redica’s global inspection intelligence:

2,500+ Japan PMDA GMP inspection events
1,700+ Swissmedic GMDP documents
18,000 additional EMA GDP documents, expanding our existing European coverage
500 Korea MFDS GMP Result Documents, fully translated and structured
Standardized inspection reasons, outcomes, and inspector details
New inspector profiles and enriched site linkages
Integration into Site Risk Scores and cross-agency analytics

Together, these datasets create a harmonized global foundation and support consistent risk evaluation, prioritization, trending and preparation across quality, regulatory, and supplier management teams.

PMDA: One of the Industry’s Strongest Early-Warning Signals

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is recognized as one of the world’s most rigorous regulators. Understanding PMDA inspection patterns is essential for manufacturers to ensure compliance, manage supplier risk, and maintain supply chain quality.

PMDA also maintains bilateral cooperation arrangements with the European Union. Since mid-2023, the PMDA has conducted Paper Assessment reviews, which are desktop records reviews, for inspected sites within the EU. These reviews can provide additional context when evaluated in conjunction with EU Member State inspection outcomes and site histories.

From late 2022 to mid-2025, Redica structured more than 2,500 PMDA inspection events. Of these, 225 were conducted on-site, with the following distribution:

Across the same period, 48% of PMDA inspections were Routine, while the remaining 52% were conducted for Pre-Approval or Post-Approval purposes.

By structuring over 2,500 PMDA inspection events and linking them across sites and organizations, Redica enables customers to more quickly:

Identify inspection frequency and inspection-type patterns by site, network, or region
Support risk-based supplier qualification and surveillance planning
Compare signals across agencies for multiple regulators at the same site

Swissmedic: High-Value Insight Into Europe’s Most Critical Manufacturing

Switzerland plays an outsized role in sterile manufacturing, biologics, and high-value pharmaceutical production. Swissmedic’s GMDP certificates and compliance documents provide some of the most reliable insight available into GMP maturity and compliance status.

These documents are operationally important particularly for injectables, biologics, and high-potency products, where compliance lapses can quickly lead to shortages, import constraints, or manufacturing suspensions.

By structuring and linking 1,700+ Swissmedic GMDP documents, Redica fills a critical gap in European regulatory visibility and enables proactive, cross-agency supplier-risk assessment.

Swissmedic’s GMP and GDP Certificates provide insight into Site Operations of inspected establishments. In the past 5 year timeframe, the Swissmedic GMP and GDP Inspection counts are as follows:

The 2024 increase may reflect, at least in part, the release of the SwissGMDP Database, which potentially accelerated inspection workflows. Additionally, Swissmedic revised its Agency Procedures on conducting inspections of establishments manufacturing or distributing medicinal products (Redica). Clarifications made in this revision around the handling of immediate actions during the final inspection meeting may accelerate inspection closure.

Notably, 99% of Inspections resulted in a Compliant Outcome, with a small number resulting in certificates issued under Conditional Compliance, indicating increased supervision to the particular site.

MFDS: Unlocking a Previously Opaque Biologics Powerhouse

Korea has rapidly become a global leader in biologics, biosimilars, and sterile manufacturing. MFDS publishes GMP Result Documents that contain inspection findings at a level of specificity rarely seen elsewhere. Historically, this information has been difficult to incorporate into global oversight because it is fragmented across portals, and available only in Korean.

By translating and structuring 500 MFDS GMP Result Documents, Redica opens visibility into a strategically vital region whose manufacturing output directly affects product quality, supply continuity, and regulatory scrutiny across North America, Europe, and Asia.

Expanded EMA GDP Coverage: Deeper Insight Into Supply-Chain Integrity

While Redica already supported EMA data, this launch adds 18,000 additional EMA GDP certificates and noncompliance reports, increasing visibility into European distribution compliance and oversight.

GDP documentation can support risk screening for distribution networks. Non-compliance often reveals vulnerabilities in temperature control, storage, transport, documentation, and anti-counterfeiting practices; issues that can affect product supply and quality even when manufacturing sites remain compliant.

This expanded dataset strengthens the industry’s ability to evaluate distributor reliability, identify weak points in multi-tier distribution networks, and anticipate supply-chain disruptions before they affect patients or markets.

From Fragmented Data to Connected Intelligence

What makes this expansion powerful isn’t just scale; it’s connection.

Across PMDA, Swissmedic, EMA, and MFDS, Redica harmonizes inspection data into a unified global view, enabling:

Stronger risk scoring and models through increased signal density
Cross-agency comparisons that reveal emerging regulatory scrutiny
Richer inspector and site context for more informed decision-making
Earlier identification of supplier and supply-chain fragility

The result is a clearer, more actionable understanding of global GMP and GDP compliance risk.

A Clearer Global Compliance View

Global manufacturing continues to grow more distributed, and regulatory expectations aren’t converging overnight. But with the right intelligence foundation, organizations can move from reactive compliance to proactive risk management.

This latest expansion strengthens Redica’s global data foundation while maintaining accessibility, comparability, and connectivity of global GMP and GDP inspection data.

If you’d like to see how these new datasets can support risk assessments, supplier oversight, and inspection readiness and compliance strategy, we’d love to show you.

Redica customers can also be on the lookout for more datasets coming soon; and deeper insights from Redica driven in part by this new data.

Request a Demo to See How Redica Can Work for You.