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
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
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
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
The Taiwanese legislature passed the “Biotech and New Pharmaceutical Development Act” in June 2007. The Act is designed to offer incentives to companies in the pharmaceutical and biotech industry. In one major change, the Act allows publicly-funded researchers to help private companies... Read More
Taiwan’s Department of Health (DOH) plans to introduce a Health Technology Assessment (HTA) system to control rising healthcare costs. This HTA system would require all medical devices, new drugs and innovative surgical procedures to demonstrate effectiveness in improving patients’ health and cutting... Read More
The Bureau of National Health Insurance (BNHI) is facing serious financial problems with a deficit of about $104 million. Last year, the BNHI borrowed $2.3 billion and owed $100 million in interest to pay for healthcare reimbursement. This year, the BNHI has... Read More