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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]
The approval of ELIQUIS in Japan is supported by the pivotal Phase 3 trial, ARISTOTLE, which evaluated the safety and efficacy of ELIQUIS versus warfarin in 18,201 patients with NVAF, including ...
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 ...
Japan: Pharmaceuticals and Medical Devices Agency (PMDA) 2014 Latvia: State Agency of Medicines Zāļu valsts aģentūra (ZVA) 2004 Liechtenstein: Office of Healthcare Amt für Gesundheit (AG) 1995 Lithuania: State Medicines Control Agency (SMCA) 2009 Malaysia: National Pharmaceutical Regulatory Agency (NPRA) Bahagian Regulatori Farmasi Negara ...
A Japanese health ministry panel on Monday recommended approval of the Alzheimer's disease treatment Leqembi, following standard approval for the drug granted by U.S. regulators last month. The ...
This flexibility eliminates the need for venous access, offering patients greater convenience. The approval was based on data from two Phase 3 clinical trials conducted in Japan and North America.