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It is similar in function to the Food and Drug Administration in the United States, the Medicines and Healthcare products Regulatory Agency in the United Kingdom, the Spanish Agency of Medicines and Medical Devices in Spain or the Food and Drug Administration in the Philippines. [2] The PhMDA has been eCTD compliant at least since December 2017 ...
Sakigake (さきがけ, lit. "pathfinder", "harbinger") is a drug designation by the Pharmaceuticals and Medical Devices Agency, the pharmaceuticals regulator of Japan. It was designed to provide easier access to novel advanced treatments. [1]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The Japanese Adverse Drug Event Report (JADER) database is a spontaneous reporting system of drug adverse events which is managed by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. [1] It has been available since 2012. [1]
It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]
The first Western compounding pharmacy was opened in Japan in 1872 by Arinobu Fukuhara operating under the name Shiseidō. 1893 Japan Pharmaceutical Association was established as the sole national professional association for pharmacists. [4] [2] In 1909, The Japan Pharmaceutical Association was legally incorporated as a public interest ...
A Japanese Accepted Name (Japanese: 日本医薬品一般的名称, Hepburn: Nihon Iyakuhin Ippan-teki Meishō) (JAN) is the official non-proprietary or generic name given to a pharmaceutical substance by the Government of Japan. [1] [2]
Ensitrelvir was approved for emergency use in Japan in November 2022, [9] [4] [5] before gaining full approval in March 2024. [1] It was approved in Singapore in November 2023. [17] In April 2023, ensitrelvir was given a "Fast Track" designation from the US Food and Drug Administration. [18]