Pharmaceutical And Medical Safety Bureau

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FDA - Japan, Letter Pharmaceutical Products

https://www.fda.gov/international-programs/cooperative-arrangements/fda-japan-letter-regarding-exchange-information-pharmaceutical-products

The U.S. Food and Drug Administration (FDA) recognizes the importance of timely communication between U.S. and Japanese governmental authorities on matters useful …

Notifications and Administrative Notices

https://www.pmda.go.jp/english/review-services/regulatory-info/0003.html

Dec 10, 2021

Ministry of Health, Labour and Welfare - mhlw.go.jp

https://www.mhlw.go.jp/english/org/policy/p13-14.html

In Pursuit of Safety of Drug and Medical Care. The bureau implements measures for securing the efficacy and safety of drugs/quasi-drugs, cosmetics and medical devices, …

Notifications Related to Safety Measures (Drugs)

https://www.pmda.go.jp/english/safety/info-services/drugs/safety-measures/0001.html

May 31, 2022

Marketed Health Products Directorate - Canada.ca

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/marketed-health-products-directorate.html

Marketed Pharmaceuticals Bureau. The Marketed Pharmaceuticals Bureau conducts post-market surveillance of marketed prescription drugs to determine the safety profile …

PFSB Japan - FDA, Confidentiality Commitment | FDA

https://www.fda.gov/international-programs/confidentiality-commitments/pfsb-japan-fda-confidentiality-commitment

Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare ______________________________ Name of foreign government agency Address: 2-2. …

Pharmaceutical Regulations in Japan 2020

https://www.jpma.or.jp/english/about/parj/eki4g6000000784o-att/2020e_ch01.pdf

the Pharmaceutical Safety and Environmental Health Bureau 2) Matters related to pharmacists 3) Supervision of the PMDA (excluding areas under the control of the …

Ministry of Health, Labour and Welfare: Information for …

https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/01.html

Drugs, Quasi drugs. You can bring your personal medicines into Japan once certain procedures are completed. This is because there are patients who need continuous …

Japan Health Policy NOW – Health Policy Players

https://japanhpn.org/en/players/

Pharmaceutical and Medical Device Agency (PMDA) The PMDA established in 2004, is a government regulatory agency responsible for evaluating new drug and medical device …

省庁による通知の訳語 - 医薬翻訳を学ぼう

https://iyakuhonyaku.wiki.fc2.com/wiki/%E7%9C%81%E5%BA%81%E3%81%AB%E3%82%88%E3%82%8B%E9%80%9A%E7%9F%A5%E3%81%AE%E8%A8%B3%E8%AA%9E

Pharmaceutical and Food Safety Bureau (PFSB) 医薬食品局 Evaluation and Licensing Division 審査管理課 Office of Medical Devices Evaluation 医療機器審査管理室薬機発 (独立行政法人医薬 …

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