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

Name: 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
Creator: Pharmaceuticals and Medical Devices Agency
Keywords: applications,approval,data,databases,marketing,notices,q-a,questions-and-answers,reliability

Information

Type

Administrative Notice

Regulated products

Regenerative Medical Products

Last updated

March 31, 2023

Description

PSEHB/MDED Administrative Notice

Organization

Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵

Country / Region

Japan

License

Other (Public Domain)

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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

Updated on March 31, 2023

pdf (601.8KB)

URL: https://www.pmda.go.jp/files/000252240.pdf
Permalink: https://data.openrid.co/en/datasets/r/b36d020c-a2b7-40dc-98f6-518ccd8d98e6
MIME Type: application/pdf

Created on: March 31, 2023
Modified on: March 31, 2023

Size: 601.8KB

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

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Regulated products

Last updated

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Country / Region

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