Links to pages containing key guidance and guidelines related to PMDA operations.
PMDA's Early Consideration
General Topics
Reviews / Clinical Trials
Project Across Multi-Offices: Companion Diagnostics / Pediatric and Orphan Drugs
Multi-Regional Clinical Trials / Real World Data (RWD) / Nanomedicine
Compliance Assessments (GLP / GCP・GPSP) / Inspections (GMP / QMS)
Post-marketing Safety Measures / Database Study
Areas / Fields
Quality / Toxicology / Pharmacokinetics / Biostatistics
New Drugs (based on the review categories)
Vaccines and Blood Products / Biosimilars
Others (Generic Products / Over-the-counter (OTC) Drugs)
In Vitro Diagnostics
Regenerative Medical Products・Gene Therapy
Medical Devices / Criteria for Medical Devices
Regulatory Procedures
Frequently Asked Questions (FAQ)
New Drug Review with Electronic Data
Accreditation of Foreign Manufacturers / Master File System
Genetically Modified Organisms
Information for Approved Products
Drugs / Medical Devices / Regenerative Medical Products
Companion Diagnostics