There is no doubt that China is and will continue to be a global hotspot for the medical industry. Yet many Western companies that rush haphazardly into China without fully understanding its business culture and mentality ultimately meet with failure. This presentation... Read More
The Korea Food and Drug Administration (KFDA) is undergoing some reorganization. In his second year at his post, Commissioner Yun Yeo-pyo has decided to restructure the KFDA to improve its efficiency and oversight of food, drug, and medical device safety. New divisions... Read More
As previously reported in our Asia Medical eNewsletter, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is working on overhauling its medical device approval process in order to reduce long review times. Part of this medical device regulation change calls for increasing the... Read More
On December 15, 2008, India’s Minister of Science and Technology, Kapil Sibal, discussed coming medical device regulations at a conference in New Delhi. These regulations are to be submitted to India’s cabinet soon by the Department of Science and Technology, which oversees... Read More
As a response to criticism over inadequate food and drug oversight, the Taiwanese Cabinet approved the creation of the Taiwan Food and Drug Administration (TFDA) on November 20, 2008. The approved draft will be sent to the Taiwanese legislature. If approved in... Read More
To deal with rising health costs and medical safety concerns, Japan’s Ministry of Health, Labor, and Welfare (MHLW) requested a 4% increase in its budget for fiscal year 2009, which begins in April. The total budget request is for 22.9 trillion yen... Read More
On September 16, 2008, high-ranking officials from both China and the U.S. met in California to discuss important issues, such as medical product importation regulations and intellectual property rights. The 19th U.S. – China Joint Commission on Commerce and Trade (JCCT) included... Read More
The Association of South East Asian Nations (ASEAN) is preparing for the upcoming implantation of the ASEAN Common Technical Dossier (ACTD) in January 2009. Drafted by the Pharmaceutical Product Working Group (PPWG) of the ACCSQ (ASEAN Consultative Committee on Standards & Quality),... Read More
The Indian government established a new Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers in July 2008. This new Department will be responsible for matters relating to the NPPA (National Pharmaceutical Pricing Authority) such as price control and monitoring, promoting... Read More
On September 1, 2008, China’s State Council approved the Ministry of Health’s (MOH) plans for reorganization. In line with the State Council’s earlier announcement in March 2008 that the currently independent State Food and Drug Administration (SFDA) would fall under the management... Read More