泰国食å“è¯å“监ç£ç®¡ç†å±€å¯åŠ¨ç”µå版通用技术文档试点计划
泰国食品和药物管理局(FDA)最近宣布,对于药品注册申报资料实行电子版通用技术文件(eCTD)试点。该试点项目将于2014年10月开始。从试点中获得反馈后,泰国FDA的电子提交系统将于2015年5月全面实施。 Read More
泰国食品和药物管理局(FDA)最近宣布,对于药品注册申报资料实行电子版通用技术文件(eCTD)试点。该试点项目将于2014年10月开始。从试点中获得反馈后,泰国FDA的电子提交系统将于2015年5月全面实施。 Read More
There is a wealth of opportunities for healthcare companies looking to expand to the Asian markets. This presentation provides an overview of important business and regulatory issues to consider for medical device companies interested in Asia. To view these presentation slides, please... Read More
The pharmaceutical market in Thailand had a 2013 value of more than $4.5 billion, almost the same size as the Taiwan market. Already the second largest in Southeast Asia (behind Indonesia). the Thai drug market is projected to double by 2020. Read More
A country of 15 million people, Cambodia’s 2013 GDP was about $15.5 billion with growth around 7%. As the Cambodian economy develops, healthcare spending has been expanding throughout the country. Though still smaller and more difficult to do business in than many... Read More
Sourcing medical devices in Asia has become a common practice as more companies are taking advantage of the lower overhead, lower labor costs and increasing technical capabilities available in the Asian countries. Medical device companies can buy and manufacture a wide array... Read More
This report on Asian CROs provides a comprehensive list of contract research organizations in Asia. The countries covered include: Japan, Taiwan, Korea, Singapore, Hong Kong, India, China, Malaysia, Philippines, Indonesia, Thailand and Vietnam. Included for each CRO are contact information, description of... Read More
The ten nations that make up the Association of Southeast Asian Nations (ASEAN) -- Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam -- together have a population of over 610 million, almost twice the population of the U.S.... Read More
Together, the ten countries of the Association of Southeast Asian Nations (ASEAN) have a combined GDP of $2 trillion and a population of more than 600 million. Indonesia, Malaysia, the Philippines, Singapore, Thailand, Brunei, Myanmar (Burma), Cambodia, Laos and Vietnam made up... Read More
The Thai pharmaceutical market is the largest in Southeast Asia, with a value of more than $4 billion in 2012. At its current rate of growth, it should more than double in size by 2020, when it is expected to reach a... Read More
The forthcoming ASEAN Medical Device Directive (AMDD) will cover harmonization for a Common Submission Dossier Template (CSDT) and will govern requirements of product registration. Read More