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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 ...
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 ...
The Health Sciences Authority headquarters at Outram Road, Singapore. HSA was formed on 1 April 2001 with the integration of five specialised agencies under the Ministry of Health: the Centre for Drug Evaluation; Institute of Science and Forensic Medicine; National Pharmaceutical Administration; Product Regulation Department; and Singapore Blood Transfusion Service.
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.
The Japanese Pharmacopoeia (日本薬局方) is the official pharmacopoeia of Japan. It is published by the Pharmaceuticals and Medical Devices Agency ...
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 ) .
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] It is analogous to the Regenerative Medicine Advanced Therapy designation in the United States and the ...