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 In 2016, Malaysia’s economy expanded 5% and the population was at 30 million. The country also has the third highest GDP per capita adjusted for purchasing power pairty (PPP) in ASEAN at $27,000, behind only Singapore and Brunei (International Monetary Fund,... Read More
Indonesia, an archipelago of over 10,000 islands, has a population of over 255 million, making it the fourth most populous country in the world. Indonesia is Southeast Asia’s largest economy, with a GDP adjusted for Purchasing Power Parity (PPP) of over... Read More
Thailand, with a population of 68 million, is Southeast Asia’s third most populous country after Indonesia (256 million) and the Philippines (104 million). As the country continues to undergo economic growth and demographic changes, Thailand’s pharmaceutical market presents numerous opportunities for foreign... 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
Recently, Prime Minister Narendra Modi’s Ministry of Health published a 108 page notification on medical devices in India. Significant changes to medical device regulations include: Device licenses will no longer expire. The manufacturer will need to pay a renewal fee every 5... Read More
In order to promote earlier market access of novel medical devices, Korea’s Ministry of Food and Drug Safety (MFDS) proposed changes for the “Regulation on Approval/Report/Review, Etc. of Medical Devices”. The proposed changes include: Designation criteria for rare-disease devices will include both... Read More
Local Chinese testing of medical devices is a key step in the approval process in China. The CFDA has charged thousands of dollars for mandatory in country testing of devices. Recently, the Chinese Food and Drug Administration (CFDA) has eliminated testing fees... Read More
This presentation provides an overview of the regulatory framework and drug registration process in India. To view these presentation slides, please click on Drug Registration in India Presentation. Table of Contents: Regulatory Framework in India FDC Registration Process in India... 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