Site Map

Outline

Consultations

Reviews

• Master File System

• Accreditation of Foreign Manufacturers

• Drugs open close

  • New Drug Review with Electronic Data
  • Biosimilar

• Regulations and Approval/Certification of Medical Devices

• Regenerative Medical Products

• Advanced Efforts open close

  • Strategy of SAKIGAKE by MHLW

• Information for Approved Products open close

  • Drugs
  • Medical Devices
  • Regenerative Medical Products
  • Companion Diagnostics

• Genetically Modified Organisms

GLP / GCP / GPSP Compliance Assessments

• GLP inspection conducted by PMDA

GMP / QMS / GCTP Inspections

• GMP

• QMS

Assessments to Registered Certification Bodies

• MDSAP

Regulatory Information

Public comments

Outline

Scientific Research and Analyses

Provision of Information regarding Post-marketing Safety

• Drugs open close

  • Risk Manegement Plan
  • The Yellow Letter / Blue Letter
  • Safety Information announced by MHLW
  • PMDA Risk Communications
  • Revisions of PRECAUTIONS
  • MHLW Pharmaceuticals and Medical Devices Safety Information
  • PMDA Alert for Proper Use of Drugs
  • Notifications Related to Safety Measures
  • English Translated Package Inserts

• Medical Devices open close

  • PMDA Risk Communications
  • Revisions of PRECAUTIONS
  • Notification on Self-inspection
  • PMDA Alert for Proper Use of Medical Devices
  • PMDA Alert for Proper Use of Medical Devices (for patients)
  • Notifications Related to Safety Measures

• Regenerative Medical Products open close

  • PMDA Risk Communications
  • Revisions of PRECAUTIONS
  • Notifications Related to Safety Measures

• In-vitro Diagnostics open close

  • Notification on Self-inspection
  • Notifications Related to Safety Measures

• Medical Safety Information

• Information regarding newly introduced Electronic Package Inserts

Regulatory Information

Public comments

Outline

Public comments

Regulatory Science

• Outline of Regulatory Science

Regulatory Science Research Administration

• Recent Publications by PMDA Staff

• Regulatory Science Research in PMDA

Regulatory Science Coordination

• The Science Board open close

  • The 7th Term (FY2024, FY2025)
  • The 6th Term (FY2022, FY2023)
  • The 5th Term (FY2020, FY2021)
  • The 4th Term (FY2018, FY2019)
  • The 3rd Term (FY2016, FY2017)
  • The 2nd Term (FY2014, FY2015)
  • The 1st Term (FY2012, FY2013)

• Measures for advanced science and technology open close

  • Subcommittee on Cell and Gene Therapy Products Produced in vivo
  • Subcommittee on Therapeutic Products Based on Extracellular Vesicles (EVs) Including Exosomes
  • Subcommittee on Microbiome
  • Subcommittee on AMR
  • Subcommittee on Rare Cancers
  • Subcommittee on Pharmaceuticals Development
  • Subcommittee on Placebo-controlled Studies
  • Subcommittee on Non-clinical Studies
  • Pharmaceuticals Subcommittee
  • Bio-products Subcommittee
  • Subcommittee on Software as a Medical Device Utilizing AI and Machine Learning
  • Subcommittee on Computer Simulation
  • Subcommittee on AI (Artificial Intelligence)
  • Subcommittee on Application of Numerical Analysis to Non-clinical Evaluation
  • Subcommittee on Evaluation of Medical Devices in Pediatric Use
  • Medical Devices Subcommittee
  • Subcommittee on Genome Editing
  • CPC (Cell Processing Center) Subcommittee
  • Cellular and Tissue-based Products Subcommittee

• RS Projects Across Multi-Offices in PMDA

Standard Development

• Outline

• Japanese Pharmacopoeia open close

  • JP Editions and Supplements
  • JP Drafts
  • JP Technical Information
  • JP FAQ
  • Pharmacopoeial Harmonization
  • Meetings & Events
  • Public comments

• Medical Device Standards

Outline

• Grand Design for Asian Pharmaceutical and Medical Device Regulatory Harmonization

• Information from PMDA open close

  • PMDA Updates
  • Chief Executive’s Statement

International Harmonization

• ICMRA

• APEC-RHSC

Bilateral Arrangements

• Confidential Arrangements

• Memorandum of Understanding/Memorandum of Cooperation

• Other cooperation schemes open close

  • Tripartite Meeting (for Antibacterial Agents)
  • Tripartite Meeting (for GCP Inspection)
  • Cooperation between WHO and PMDA on training for regulatory authorities

Cooperation with Asia

• Multilateral Cooperation open close

  • Asian Network Meeting (ANM)

• Bilateral Cooperation open close

  • China
  • Chinese Taipei
  • India
  • Indonesia
  • Malaysia
  • Philippines
  • Thailand
  • Vietnam
  • China/Japan/Korea Tripartite Cooperation

Asia Training Center

• Seminar Schedule

• Training Materials

• FAQ open close

  • Frequently Asked Questions (FAQ) about Seminar
  • Frequently Asked Questions (FAQ) about E-learning Courses

Overseas Office

• PMDA Asia Office

• PMDA Washington D.C. Office

Public comments

Outline of PMDA

• History

• Services of PMDA

• List of Executives

• Organization

Message from the Chief Executive

• Chief Executive’s Statement

PMDA Philosophy

Mid-term Targets / Mid-term Plan

Annual Reports

Frequently Asked Questions (FAQ)

Announcements