Real World Data（RWD）

Links to major regulatory information of Real World Data（RWD）.
 

Regulations and Notifications

• Points to Consider When Registry Data are utilized for Partial Change Approval Applications or Revision of Electronic Package Insert for Prescription Drugs [102KB]

October 4, 2024 PSB/PED Notification No. 1004-4・ PSB/PSD Notification No. 1004-1

 

• Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Regenerative Medical Products[601.79KB]

March 31, 2023　PSEHB/MDED Administrative Notice

 

• Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Drugs[201.63KB]

September 14, 2022 PSEHB/PED Administrative Notice

 

• Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications[495.56KB]

March 23, 2021 PSEHB/PED Notification No. 0323-2 PSEHB/MDED Notification No. 0323-2

 

• Basic principles on Utilization of Registry for Applications[362.43KB]

March 23, 2021 PSEHB/PED Notification No. 0323-1 PSEHB/MDED Notification No. 0323-1

 

• (In Japanese)Basic principles in conducting a validation study of outcome definitions used for post-marketing database study[727KB]

July 31, 2020　PMDA/CRS Notification No.0731002・PMDA/CPE Notification No.0731002

 

• Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Regenerative Medical Products[464.08KB]

March 23, 2020　PSEHB/MDED Notification No. 0323-4

 

• (In Japanese)Procedures for Developing Post-marketing Study Plan[315KB] (originaly published as “Procedures for Developing Post-marketing Study Plan[308KB]” by PMDA in January 2018)

March 14, 2019 PSEHB/PED Notification No.0314-4・PSEHB/SD Notification No.0314-4

 

• Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Medical Devices[462.43KB]

December 19, 2018　PSEHB/MDED Notification No. 1219-4

 

• Points to Consider for Ensuring the Reliability of Post-marketing Database Study for Drugs[462.39KB]

February 21, 2018　PSEHB/PED Notification No. 0221-1

 

• (In Japanese)Contents and format of a study protocol for Post-marketing Database Study[750KB]

January 23, 2018

 

• (In Japanese)Amendment of Ministerial Ordinance on Good Post-marketing Study Practice for Drugs[173KB]

October 26, 2017 Ordinance of MHLW No.116

 

• (In Japanese)Basic principles on the utilization of health information databases for Post-Marketing Surveillance of Medical Products[228KB]

June 09, 2017 PSEHB/PED Notification No.0609-8・PSEHB/SD Notification No.0609-4

 

• Guidelines for the Conduct of Pharmacoepidemiological Studies in Drug Safety Assessment with Medical Information Databases[550KB]

March 31, 2014