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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]
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]
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 ...
In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
It is commonly known as Kōrō-shō (厚労省) in Japan. The ministry provides services on health, labour and welfare. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or Kōsei-shō ( 厚生省 ) and the Ministry of Labour or Rōdō-shō ( 労働省 ) .
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 ...
It was enacted in 1953 under the name of Narcotics Control Law (麻薬取締法 Mayaku torishimari hō) and was renamed current title in 1990 along with Japan's ratification of Convention on Psychotropic Substances in the same year. [1] It is often abbreviated to Makōhō (麻向法). [2] Japan has four separate laws to regulate drugs.