Japan
Pharmaceuticals and Medical Devices Agency (PMDA) · Asia-Pacific
Executive summary
Japan is the world's third-largest pharmaceutical market and operates an independent regulatory system administered by the Pharmaceuticals and Medical Devices Agency (PMDA) under the policy direction of the Ministry of Health, Labour and Welfare (MHLW). The Pharmaceuticals and Medical Devices Act (PMD Act, formerly Pharmaceutical Affairs Law) governs the framework. New drugs are approved through a J-NDA (Japanese New Drug Application) following PMDA scientific review and MHLW final decision following PAFSC (Pharmaceutical Affairs and Food Sanitation Council) deliberation. Japan does not operate formal reliance pathways but accepts foreign clinical data with appropriate ethnic factor bridging following the ICH E5 framework. The Sakigake (Pioneer) designation, expanded in 2024, provides accelerated review for innovative medicines targeting Japanese patients first; the Conditional Early Approval System (Article 14-2-3) and Emergency Approval System (Article 14-2-2, introduced 2022 in response to COVID-19) provide additional accelerated routes. All branded prescription medicines reimbursed under the National Health Insurance (NHI) are subject to mandatory NHI price listing within 60–90 days of MHLW approval, with biennial price revisions and product-specific price-volume agreements. The 2024 NHI price revision applied a 4.6% average price reduction (long-listed products faced steeper cuts).
About the authority
PMDA is an Independent Administrative Agency under MHLW. It conducts scientific reviews, GCP/GLP/GMP inspections, and post-marketing safety surveillance. The MHLW PAFSC deliberates on PMDA review reports and makes the final marketing authorisation recommendation, with MHLW issuing the formal approval. PMDA also operates the relief system for adverse drug reactions and the Office of International Programs for liaison with FDA, EMA, NMPA, and others.
Reliance & recognition
PMDA does not formally rely on third-country approvals. Foreign clinical data is accepted with appropriate bridging per ICH E5; PMDA participates in Project Orbis (oncology) for parallel review with FDA and other partners and operates simultaneous global development consultations with FDA/EMA. GMP compliance is recognised under MRAs with EU, US (since 2018), and Switzerland for selected dosage forms.