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Home / Products / Page 8

Showing 113–128 of 155 results

  • PMDA-PSEHB-MDED No. 0709-2: Ensuring the Quality and Safety of Gene Therapy Products

    PMDA-PSEHB-MDED No. 0709-2: Ensuring the Quality and Safety of Gene Therapy Products

    $150.00
    Add to cart
  • PMDA/PFSB Notification No. 0304004/2009: Guideline for the Quality, Safety, &  Efficacy Assurance of Follow-on Biologics

    PMDA/PFSB Notification No. 0304004/2009: Guideline for the Quality, Safety, & Efficacy Assurance of Follow-on Biologics

    $30.00
    Add to cart
  • PMDA: Basic Principles of Risk-based Monitoring

    PMDA: Basic Principles of Risk-based Monitoring

    $15.00
    Add to cart
  • PMDA: Basic Principles on Global Clinical Trials (Reference Cases)

    PMDA: Basic Principles on Global Clinical Trials (Reference Cases)

    $15.00
    Add to cart
  • Sale! PMDA: Guideline Pharmacokinetic and Pharmacodynamic Analysis

    PMDA: Guideline Pharmacokinetic and Pharmacodynamic Analysis

    $15.00 Original price was: $15.00.$14.00Current price is: $14.00.
    Add to cart
  • PMDA: New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law

    PMDA: New Regulations of Non-Corrective Colored Contact Lenses under the Pharmaceutical Affairs Law

    $15.00
    Add to cart
  • PMDA: Points to Consider for Reprocessed Single-use Medical Devices

    PMDA: Points to Consider for Reprocessed Single-use Medical Devices

    $15.00
    Add to cart
  • PROCEDURES AND REQUIREMENTS FOR COSMETIC PRODUCTS RELATED TO STRAIGHTEN OR CURL THE HAIR

    PROCEDURES AND REQUIREMENTS FOR COSMETIC PRODUCTS RELATED TO STRAIGHTEN OR CURL THE HAIR

    $75.00
    Add to cart
  • PROCEDURES FOR THE TRANSFER OF REGISTRATION OF PRODUCTS AND CLINICAL TESTING SUBJECT TO HEALTH SURVEILLANCE NOTIFICATION

    PROCEDURES FOR THE TRANSFER OF REGISTRATION OF PRODUCTS AND CLINICAL TESTING SUBJECT TO HEALTH SURVEILLANCE NOTIFICATION

    $250.00
    Add to cart
  • Q&A-Biosimilar 000272338_page-0001

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

    $10.00
    Add to cart
  • PROVISIONS ON THE IMPORT, COMMERCIALIZATION AND DONATION OF USED AND REFURBISHED HEALTHCARE PRODUCTS

    PROVISIONS ON THE IMPORT, COMMERCIALIZATION AND DONATION OF USED AND REFURBISHED HEALTHCARE PRODUCTS

    $30.00
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  • PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs

    PSEHB 0608-4/2020 Guideline for Exposure-Response Analysis of Drugs

    $30.00
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  • Sale! PSEHB No. 0122-7 - Clinical Trials Conducted on Ethical Grounds

    PSEHB No. 0122-7 – Clinical Trials Conducted on Ethical Grounds

    $15.00 Original price was: $15.00.$14.00Current price is: $14.00.
    Add to cart
  • PSEHB No. 0731-1 :  Conditional Early Approval System for Innovative Medical Devil Products (Fast-Break Scheme)

    PSEHB No. 0731-1 : Conditional Early Approval System for Innovative Medical Devil Products (Fast-Break Scheme)

    $15.00
    Add to cart
  • PSEHB No.0201: Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software

    PSEHB No.0201: Applications for Marketing Approval related to the Period of Transitional Measures with respect to the Handling of Medical Device Software

    $15.00
    Add to cart
  • Biosimilar-regulation-000267479-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
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