Real World Data Use in Pharmaceutical Companies in Japan: Current Status and Issues from Survey of Japan Pharmaceutical Manufacturers Association

Author:

KOTO Ryo12,ASABE Shinichi13,ITO Akira14,DAIDOJI Kasumi15,ISHII Manabu16,TOGO Kanae17,MATSUZAWA Hiroshi18

Affiliation:

1. Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Japan

2. AstraZeneca K.K., Japan

3. AbbVie GK, Japan

4. DAIICHI SANKYO COMPANY, LIMITED, Japan

5. Eisai Co., Ltd., Japan

6. Mitsubishi Tanabe Pharma Corporation, Japan

7. Pfizer Japan Inc., Japan

8. Astellas Pharma Inc., Japan

Publisher

Japanese Society for Pharmacoepidemiology

Reference43 articles.

1. 1) 首相官邸.知的財産戦略本部.構想委員会.厚生労働省が進めるデータヘルス改革.2020.[https://www.kantei.go.jp/jp/singi/titeki2/tyousakai/kousou/2020/dai3/siryou4.pdf (accessed 2023-8-16) ]

2. 2) U.S. Department of Health and Human Services Food and Drug Administration. Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products. Guidance for Industry. (September, 2022). [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drug-and-biological-products (accessed 2023-8-16) ]

3. 3) U.S. Department of Health and Human Services Food and Drug Administration. Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products. Draft Guidance for Industry. (September, 2021). [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-electronic-health-records-and-medical-claims-data-support-regulatory (accessed 2023-8-16) ]

4. 4) U.S. Department of Health and Human Services Food and Drug Administration. Data Standards for Drug and Biological Product Submissions Containing Real-World Data, Draft Guidance for Industry. (October, 2021). [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-standards-drug-and-biological-product-submissions-containing-real-world-data (accessed 2023-8-16)]

5. 5) U.S. Department of Health and Human Services Food and Drug Administration. Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. Draft Guidance for Industry. (November, 2021). [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-data-assessing-registries-support-regulatory-decision-making-drug-and-biological-products (accessed 2023-8-16)]

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