The Taiwan Bureau of National Health Insurance (BNHI) had recently announced its 6th drug price cut to reduce drug prices. This cut was to take effect starting September 1, 2009. Taiwan’s Department of Health (DOH) Minister Yang Chih-Liang has pushed back this... Read More
As previously reported in our Asia Medical eNewsletter, the Taiwan Food and Drug Administration (TFDA) will combine the Bureau of Food Safety, Bureau of Pharmaceutical Affairs, Bureau of Food and Drug Analysis, and Bureau of Controlled Drugs in order to better integrate... Read More
The Office of the United States Trade Representative (USTR) recently issued a 2009 National Trade Estimate Report on Foreign Trade Barriers, with details on over 50 countries. Taiwan was one specific country where the USTR had updates on the pharmaceutical and medical... 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
Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
Taiwan’s Department of Health (DOH) has mandated that local drug manufacturers comply with the “Guideline for International Standard Site Inspection,” based on the Pharmaceutical Inspection Cooperation Theme (PIC/S). As of now, the DOH has sent requests to over 160 local drug manufacturers... Read More
When medical companies think of bringing their products to the Asian markets, they typically think of larger countries like China, Japan, or Korea first. However, other smaller Asian countries such as Singapore and Malaysia can be worthwhile destinations as well. Although they... Read More
The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS,... Read More
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and... Read More