China currently has virtually no specific policies or legislation regarding orphan drugs despite having 16.8 million patients with rare diseases, according to the Chinese Center for Disease Control and Prevention. Furthermore, many orphan drugs approved in western countries are unavailable in China.... Read More
Korea has emerged as a leading pharmaceutical market and global hub in Asia over the last two decades. With a population of 50 million, Korea is the third largest pharmaceutical market in the Asia-Pacific region. Market Size and Growth In 2016,... Read More
Introduction Despite its small population of 5.6 million, Singapore is a key drug market for Western pharmaceutical companies. Singapore’s pharmaceutical market is currently estimated to be about $820 million. It is expected to grow at a steady rate of 6% in 2017,... Read More
There are several steps to consider when entering the Asian medical device market. This presentation covers 10 essential steps to help grow your business in Asia. Case studies will be used to demonstrate key points. To view these presentation slides, please click... Read More
Over the last few years, 80% of the drug clinical trials in China have been withdrawn with their dossiers for product registration from the China Food and Drug Administration (CFDA). Drug companies are worried that fraudulent clinical trial data could get them... Read More
In March 2017, the China Food and Drug Administration (CFDA) has released draft rules allowing MNCs to include Chinese patients in the earliest possible stages of drug multi-regional clinical trials (MRCTs). These policies are meant to significantly reduce foreign drug registration timelines.... Read More
Several groups in Japan have announced plans to conduct clinical studies on donated stem cells in order to commercialize regenerative therapies. These studies will begin in April 2017. Applications of these studies include skin grafts for burn victims, liver cirrhosis tissue regeneration,... Read More
Thailand is leading clinical trial research in Southeast Asia, with potential for continued growth in coming years. An increasing number of overseas pharmaceutical companies are finding Thailand to be a prime destination to conduct drug clinical trials. Researchers are able to host... Read More
In late January, 2017, India’s Central Drugs Standard Control Organization (CDSCO) finally released Medical Device Rules, which establish different regulatory norms for medical devices and drugs. For over 10 years, the Indian government has been trying to set up new medical device... Read More
This article was also published on MedTech Intelligence. Regenerative medicine focuses on harnessing the body’s ability to heal itself by restoring the functionality of damaged tissues and organs. Current medicine treats symptoms but oftentimes does not repair the underlying problems, which is... Read More