Skip to content
  • About GRP
    • Why Choose Us
    • Leadership
    • Brochure
    • Careers
  • Countries
    • Canada’s Health Canada
    • United States’ FDA
    • Brazil
    • Mexico’s COFEPRIS
    • Europe’s EMA
    • Australia
    • China
    • Japan’s PMDA
    • Korea’s Ministry of Food and Drug Safety (MFDS)
    • Taiwan’s Food and Drug Administration (TFDA)
    • Singapore’s HSA
    • India’s CDSCO

    North America

    Canada

    United States of America

    Latin AMerica

    Brazil

    Mexico

    Europe

    European Union

    Australia

    Australia

    Asia

    China

    Japan

    South Korea

    Taiwan

    Singapore

    India

  • Services

    Medical Devices

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Strategy
    • Regulatory Affairs
    • Product Registration
    • Medical Writing
    • Health Authority Consultation
    • Clinical

    Pharmaceuticals

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Strategy
    • Regulatory Affairs
    • Product Registration
    • Regulatory Operations
    • Health Authority Consultation

    Nutraceuticals / Food Supplements

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Affairs
    • Regulatory Strategy
    • Verification of Nutrient Claims
    • Verification of Health Claims

    Cosmetics & Personal Care Products

    • Authorized Local Agent
    • Regulatory Intelligence
    • Regulatory Affairs
    • Regulatory Strategy
    • Cosmetic Packaging and Labeling Review
    • Product Classification and Formulation Review

    Pharmacovigilance

    • Overview
    • GRP Pharmacoviglance Services

    Quality

    • Preparation for FDA Inspections
    • GMP Mockup Quality Audits
    • ISO 13485 Quality Audits
    • GCP Audits
    • cGTP Audits
    • GAP Analysis Audits
    • Foreign Manufacture Accreditation (FMA)
    • QA SOPs Development
  • Resource Center
    • Blog
    • Market Access Special Programs
    • Press Releases
    • White Papers
    • Case Studies
    • Videos
    • Presentations
    • Brochure
  • RI Platform
    • Japan Regulatory Intelligence (RI)
    • China (NMPA) Regulatory Intelligence
    • Brazil
    • Mexico Regulatory Intelligence (RI)
    • USA Regulatory Intelligence (RI)

    Japan

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    China

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    Brazil

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    Mexico

    • Health Authority
    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements

    USA

    • Medical Device
    • Pharmaceuticals
    • Clinical Trials
    • Cosmetics
    • Food Supplements
  • Contact Us
  • About GRP
    • Why Choose Us
    • Leadership
    • Brochure
    • Careers
  • Countries
    • Canada’s Health Canada
    • United States’ FDA
    • Brazil
    • Mexico’s COFEPRIS
    • Europe’s EMA
    • Australia
    • China
    • Japan’s PMDA
    • Korea’s Ministry of Food and Drug Safety (MFDS)
    • Taiwan’s Food and Drug Administration (TFDA)
    • Singapore’s HSA
    • India’s CDSCO
  • Services
  • Resource Center
    • Blog
    • Market Access Special Programs
    • Press Releases
    • White Papers
    • Case Studies
    • Videos
    • Presentations
    • Brochure
  • RI Platform
    • Japan Regulatory Intelligence (RI)
    • China (NMPA) Regulatory Intelligence
    • Brazil
    • Mexico Regulatory Intelligence (RI)
    • USA Regulatory Intelligence (RI)
  • Contact Us
  • About GRP
    • Why Choose Us
    • Leadership
    • Brochure
    • Careers
  • Countries
    • Canada’s Health Canada
    • United States’ FDA
    • Brazil
    • Mexico’s COFEPRIS
    • Europe’s EMA
    • Australia
    • China
    • Japan’s PMDA
    • Korea’s Ministry of Food and Drug Safety (MFDS)
    • Taiwan’s Food and Drug Administration (TFDA)
    • Singapore’s HSA
    • India’s CDSCO
  • Services
  • Resource Center
    • Blog
    • Market Access Special Programs
    • Press Releases
    • White Papers
    • Case Studies
    • Videos
    • Presentations
    • Brochure
  • RI Platform
    • Japan Regulatory Intelligence (RI)
    • China (NMPA) Regulatory Intelligence
    • Brazil
    • Mexico Regulatory Intelligence (RI)
    • USA Regulatory Intelligence (RI)
  • Contact Us
  • Q&A-Biosimilar-Notice-000272338
    Japan

    Administrative Notice January 25, 2024 Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars (PSEHD/PED) Notification No. 0204, Ministry of Health, Labour and Welfare (MHLW), dated February 4, 2020

    $10.00 Add to cart
  • Biosimilar-regulation-000267479-japan
    Japan

    PSEHD/PED Notification No.0204-1 February 4, 2020 Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics (PFSB/ELD Notification No. 0304007

    $16.00 Add to cart
  • Q&A-Biosimilar 000272338_page-0001
    Japan

    Provisional Translation (as of December 2024) PFSB/ELD Notification No. 0214-1 February 14, 2013

    $10.00 Add to cart
  • Remote Inspection
    Japan

    Remote Inspection

    Read more
  • Marketing Application - Home use MD for Diagnostic
    Japan

    Marketing Application – Home use MD for Diagnostic

    Read more
  • Guidance for Eval of (AI) Assisted Systems
    Japan

    Guidance for Eval of (AI) Assisted Systems

    Read more
  • 1
  • 2
  • 3
  • 4
  • …
  • 24
  • 25
  • 26
  • →
View Cart
$0.00 0 Cart
Recently Viewed
$0.00 0 Cart
  • Documents
  • Cart
  • Your Downloads
  • Account details
  • Documents
  • Cart
  • Your Downloads
  • Account details

ABOUT GRP GROUP

  • About US
  • Leadership
  • Why Choose Us

Useful Links

  • Contact Us
  • Brochures
  • Resource Center

GRP Headquarters (USA)

22 Boston Warf Road, Boston, MA, 02210, USA
Tel : (+1 ) 781 - 672 -4200
Info@globalregulatorypartners.com

GRP Group Offices

  • GRP USA
  • GRP Japan
  • GRP China
  • GRP Korea
  • GRP Brazil
  • GRP Mexico

Follow Us on Social Media

Twitter Youtube Linkedin
  • Privacy Policy
  • Terms & Conditions
  • Cookies Policy
  • Other Policies

Copyright ©2023 Global Regulatory Partners

Contact Us!