Quality

Links to major regulatory information of Quality.
 

​Regulations and Notifications

GMP

• Handling of Applications for GMP Inspections[70.72KB]

March 30, 2005　PFSB/ELD Notification No. 0330006・PFSB/CND Notification No. 0330005

Clinical Trial Notification

• Example of Documents on Assessment and Control of DNA Reactive (Mutagenic) Impurities attached to Clinical Trial Notification (Early Consideration) [399KB]

January 16, 2025 Administrative Notice

Oligonucleotide Therapeutics

• Questions and Answers (Q&A) on "Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics"[46.44KB]

June 9, 2022　PSEHB/PED Administrative Notice

 

• Points to Consider for Quality Assurance and Evaluation of Oligonucleotide Therapeutics[155.72KB]

September 27, 2018　PSEHB/PED Notification No. 0927-3

Application for Marketing Approval

• Checklist for Common Inquiry Cases to Be Noted When Submitting Approval Applications for New Active Ingredient Containing Pharmaceuticals (Chemical Products) (Early Consideration) [337KB]

January 16, 2025 Administrative Notice

 

• Guideline for Descriptions on Application Forms for Marketing Approval of Drugs, etc. under the Revised Pharmaceutical Affairs Law[728.95KB]

February 10, 2005　PFSB/ELD Notification No. 0210001

Specifications and Test Methods

• Rationalization of descriptions in the specification column in approval application forms for prescription drugs[242.4KB]

　 January 28, 2022  Administrative Notice
 

• Notes on the Principles on Bioequivalence Studies of Oral Solid Dosage Forms with Manufacturing Process Changes[253.71KB]

　 April 19, 2013  Administrative Notice
 

• Handling of Prescription Drugs Having Different Crystalline Forms, etc.[33.01KB]

　 June 16, 2011 PFSB/ELD Notification No. 0616-1

Manufacturing Control and Quality Control

• Handling of Changes to Approved Product Information Pertaining to the Quality of Drugs[175.58KB]

　 March 9, 2018  PSEHB/PED Notification No. 0309-1・PSEHB/CND Notification No. 0309-1

Related Links

• Master File System
• GMP compliance inspection
• Regulations Regarding Living Modified Organisms (Genetically Modified Organisms)
• Japanese Pharmacopoeia(links to the website of the National Institute of Health Sciences)

Frequently Asked Questions (FAQ)

• GMP/QMS