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Medicinal Products Lifecycle
  1. Discovery
  2. Preclinical
  3. Clinical
  4. Dossier
  5. Authorities
  6. Approval
  7. Manufacturing
    Quality regulations
  8. Export & Import
  9. Pricing & Reimburcement
  10. Marketing
  11. Postmarketing
  12. Reevaluation & Reexamination
Medical Devices
Japan Monitor (ISSN 1550-3429)
Information Meetings
Legislation and Agreements
All in Japan (ISSN 1550-3402)
E-health Japan (ISSN 1550-3410)
EU Pharma & Medical Devices
Free documents

Click on the sub-categories of the menu in the left side to view the available documents.

7. Manufacturing




Japan Master Files (Single User License)Japan Master Files (Single User License)
Code:7_D_M001
Price: $750.00
Quantity in Basket: none
 



Japan Master Files (Enterprise-wide Use License)Japan Master Files (Enterprise-wide Use License)
Code:7_D_M002
Price: $3,250.00
Quantity in Basket: none
 



Enforcement Regulations of PAL: Regulations for Buildings and Facilities (Single User License)Enforcement Regulations of PAL: Regulations for Buildings and Facilities (Single User License)
Code:7_D_B001
Price: $375.00
Quantity in Basket: none
 



Enforcement Regulations of PAL: Regulations for Buildings and Facilities (Enterprise License)Enforcement Regulations of PAL: Regulations for Buildings and Facilities (Enterprise License)
Code:7_D_B002
Price: $1,950.00
Quantity in Basket: none
 



Standards for QA for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Single User License)Standards for QA for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Single User License)
Code:7_D_B003
Price: $275.00
Quantity in Basket: none
 



Standards for QA for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Enterprise-wide Use License)Standards for QA for Drugs, Quasi-drugs, Cosmetics and Medical Devices (Enterprise-wide Use License)
Code:7_D_B004
Price: $1,450.00
Quantity in Basket: none
 



Standards for Manufacturing Control and QA for Medical Devices / In-vitro Diagnostics (Single User)Standards for Manufacturing Control and QA for Medical Devices / In-vitro Diagnostics (Single User)
Code:7_D_B005
Price: $475.00
Quantity in Basket: none
 



Standards for MC and QA for Medical Devices / In-vitro Diagnostics (Enterprise License)Standards for MC and QA for Medical Devices / In-vitro Diagnostics (Enterprise License)
Code:7_D_B006
Price: $2,950.00
Quantity in Basket: none
 



Standards for Manufacturing Control and QA for Drugs and Quasi-drugs (Enterprise License)Standards for Manufacturing Control and QA for Drugs and Quasi-drugs (Enterprise License)
Code:7_D_B008
Price: $1,950.00
Quantity in Basket: none
 



Agreement on Mutual Recognition between Japan and EC: Japanese RegulationsAgreement on Mutual Recognition between Japan and EC: Japanese Regulations
Code:7_D_K001
Price: $150.00
Quantity in Basket: none
 



Revision of the Guideline on the Impurities in the Medicinal Products with New Active IngredientsRevision of the Guideline on the Impurities in the Medicinal Products with New Active Ingredients
Code:7_D_K002
Price: $175.00
Quantity in Basket: none
 



Manufacture and Quality Control of Drugs and Medical Devices Originating from Living OrganismsManufacture and Quality Control of Drugs and Medical Devices Originating from Living Organisms
Code:7_D_K003
Price: $375.00
Quantity in Basket: none
 



MHLW Notification No. 210 - Standards for Raw Materials Originating from Living OrganismsMHLW Notification No. 210 - Standards for Raw Materials Originating from Living Organisms
Code:7_D_K004
Price: $475.00
Quantity in Basket: none
 



Self-inspection  of Orthopedic Surgery Appliances and Devices (Single User License)Self-inspection of Orthopedic Surgery Appliances and Devices (Single User License)
Code:7_D_K005
Price: $125.00
Quantity in Basket: none
 



Self-inspection  of Orthopedic Surgery Appliances and Devices (Enterprise-wide Use License)Self-inspection of Orthopedic Surgery Appliances and Devices (Enterprise-wide Use License)
Code:7_D_K006
Price: $950.00
Quantity in Basket: none