What It Is

The Act on the Protection of Personal Information (APPI), enacted in 2003 and amended through 2024, is Japan's cornerstone national regulation for handling personal data. It defines personal information broadly, including pseudonymous data, and mandates protections for Japanese residents' data with extraterritorial reach for foreign businesses targeting the market. APPI balances privacy rights with data utility via a principle-based, risk-focused approach overseen by the Personal Information Protection Commission (PPC).

Key Components

• Core principles: purpose limitation, data minimization, transparency, security, and data subject rights (access, correction, deletion within 30 days).
• Heightened rules for sensitive data (e.g., medical, racial) requiring explicit consent.
• Pseudonymously Processed Information framework for analytics flexibility.
• Four security categories: systematic, human, physical, technical.
• PPC enforcement with ¥100 million fines; no mandatory certification but voluntary P Mark.

Why Organizations Use It

Mandatory for data handlers to avoid fines, breaches, and market barriers. Drives trust (78% consumer preference), enables cross-border transfers, yields 20-30% efficiency gains, and creates competitive moats in tech, finance, e-commerce.

Implementation Overview

Phased 12-24 month framework: gap analysis, governance/DPO appointment, technical controls, training, monitoring. Applies to all sizes/industries handling Japanese data; SMEs lighter touch, enterprises full GRC integration.

What It Is

FDA 21 CFR Part 11 is a U.S. regulation establishing criteria for electronic records and electronic signatures to be trustworthy, reliable, and equivalent to paper records and handwritten signatures. It applies to FDA-regulated industries using electronic systems for predicate-rule-required records. The approach is risk-based, with narrow scope focused on relied-upon electronic records, per 2003 FDA guidance exercising enforcement discretion on certain elements.

Key Components

• Subparts A-C: scope, electronic records controls (§11.10 closed systems, §11.30 open systems), signatures (§11.50-11.300).
• Core controls: validation, audit trails, access/authority/device checks, training, documentation, signature uniqueness/linking.
• Built on ALCOA+ principles; no formal certification, but inspection readiness required.

Why Organizations Use It

• Mandatory for electronic reliance in pharma, devices, biologics to avoid enforcement.
• Ensures data integrity, non-repudiation; reduces inspection risks, enables digital transformation.
• Builds regulator trust, accelerates batch release, supports quality investigations.

Implementation Overview

• Phased: scoping, risk assessment, CSV (IQ/OQ/PQ), SOPs, training.
• Targets life sciences; risk-based for all sizes; FDA audits via inspections.