What It Is

The Act on the Protection of Personal Information (APPI) is Japan's cornerstone privacy regulation, enacted in 2003 and amended through 2022. It governs collection, use, and protection of personal data by businesses handling Japanese residents' information. APPI employs a risk-based approach balancing privacy rights with data utility, including pseudonymously processed information.

Key Components

• Core principles: purpose limitation, explicit consent for sensitive data, data subject rights (access, correction, deletion), security controls.
• Four security categories: systematic, human, physical, technical.
• Overseen by Personal Information Protection Commission (PPC) with ¥100M fines.
• No formal certification; compliance via guidelines and self-audits.

Why Organizations Use It

Mandatory for data handlers to avoid PPC penalties, reputational harm, and market barriers. Builds consumer trust (78% prefer compliant brands), enables cross-border transfers, yields 15-25% efficiency gains, and provides competitive edges in tech, finance, e-commerce.

Implementation Overview

Phased 5-stage framework (12-24 months): gap analysis, governance design, technical deployment, testing, continuous monitoring. Applies to all sizes, industries processing Japanese data; extraterritorial for foreign entities targeting Japan.

What It Is

Good Manufacturing Practice (GMP) is a legally enforceable regulatory framework establishing minimum standards for manufacturing pharmaceuticals, biologics, and related products. Its primary purpose is to ensure products are consistently produced and controlled to meet quality, safety, and efficacy criteria through preventive controls rather than end-product testing alone. It adopts a risk-based approach (e.g., ICH Q9 QRM) spanning the product lifecycle.

Key Components

• Core pillars: 5 Ps (People, Premises, Processes, Procedures, Products).
• Pharmaceutical Quality System (PQS) per ICH Q10, including CAPA, change control, audits.
• ~200+ requirements across FDA 21 CFR 211, EU EudraLex Vol. 4, WHO GMP.
• Compliance via inspections, no central certification but enforceable by regulators.

Why Organizations Use It

• Mandatory for market access in pharma/food/cosmetics; avoids recalls, fines.
• Reduces contamination/mix-up risks; builds supply chain reliability.
• Enhances reputation, enables global trade via PIC/S/MRAs.

Implementation Overview

Phased: gap analysis, Validation Master Plan, training, qualification (IQ/OQ/PQ). Applies to all sizes in regulated industries globally; verified by regulatory audits.