This spiral-bound, 5" x 7.5" book contains information concerning pharmaceutical administration, regulations, and new drug development in Japan updated biannually by the English RA Info Task Force, International Affairs Committee, Japan Pharmaceutical Manufacturers Association. The contents are not abstracts of governmental rules or regulations but concise descriptions of the most current practices by the regulatory agencies and the industry that the working group complies. It does not contain anything related to forecasts.

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• 1-249 copies:  $15.95             • 250-499 copies:  $14.95
• 500-749 copies: $13.95          • 750+ copies:  $12.95


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* Based on quantities of a single book title

ORGANIZATION AND FUNCTION OF THE MINISTRY OF HEALTH, LABOUR AND WELFARE

PHARMACEUTICAL LAWS AND REGULATIONS
      1. Pharmaceutical Laws
      2. Pharmaceutical Affairs Law
      3. Outline of Pharmaceutical Regulations
      4. Manufacturing/Distribution Approvals
      5. Japanese Pharmacopoeia and Other Standards
      6. Pharmaceutical Supervision

DRUG DEVELOPMENT
      1. Process from Development to Approval and License
      2. Data Required for Approval Applications
      3. Guidelines Concerning Drug Approval Applications
      4. Requirements for Drug Manufacturing and Marketing
         Approvals and Manufacturing Business Licenses
      5. Others

POST-MARKETING SURVEILLANCE OF DRUGS
      1. GPSP
      2. Data Compliance Surveys and Compliance Surveys
         of Manufacturers/Distributors Based on GPSP
      3. GVP
      4. Adverse Drug Reactions and Infections Reporting System
      5. Periodic Infection Reports for Biological Products
      6. Reexamination System (Article 14-4 of the Law)
      7. Reevaluation System (Article 14-5)

SUPPLY AND DISSEMINATION OF DRUG INFORMATION
      1. Package Inserts
      2. Information to Supplement Package Inserts
      3. Supply and Dissemination of Safety Management Information
      4. Electronic Information Dissemination
      5. Package Inserts of Non-prescription Drugs

HEALTH INSURANCE PROGRAMS AND DRUG PRICING IN JAPAN
      1. History of Health Insurance Programs
      2. Medical Benefits Offered under Health Insurance Programs
      3. Reimbursement of Medical Fees
      4. National Health Insurance Drug Price List
      5. Pricing Formula for Reimbursement Price Revisions
          of Drugs Listed in the NHI Drug Price List
      6. Recent Revisions of the NHI Drug Price List
      7. Determination of Reimbursement Prices for New Drugs
      8. Entry of Generic Drugs in the NHI Drug Price List

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