<b>1. The Feature and Implementation Process of Japanese RMP from the Regulatory Authority's Viewpoint </b>-Reference-Cited by-同舟云学术

1. The Feature and Implementation Process of Japanese RMP from the Regulatory Authority's Viewpoint

Published:2015 Issue:2 Volume:19 Page:103-108
ISSN:1342-0445
Container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
language:en
Short-container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku

Author:

MORI Kazuhiko¹

Affiliation:

1. Ministry of Health, Labour and Welfare

Publisher

Japanese Society for Pharmacoepidemiology

Subject

General Medicine

Reference4 articles.

1. 4) ICH. Clinical Safety data management: periodic safety update reports for marketed drugs E2C (R1). [http://www.pmda.go.jp/ich/e/e2cr1_03_4_25e.pdf (accessed 2014-12-22)］．

2. 7) ICH Pharmacovigilance planning E2E. [http://www.pmda.go.jp/ich/e/e2e_05_9_16e.pdf (accessed 2014-12-22)]．

3. 10) The Sentinel Initiative. [http://www.fda.gov/downloads/Safety/FDAsSentinelInitiative/UCM124701.pdf (accessed 2014-12-22)]．

4. 11) TEMPLATE FOR EU RISK MANAGEMENT PLAN (EU-RMP). [http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_ form/2009/10/WC500006317.pdf (accessed 2014-12-22)]．

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