According to a recent market research report by Triton Market Research, Asia’s CDX market was valued at $1.4 billion in 2022 and is likely to grow to $3.85 billion by 2030 with a CAGR of 13%. While CDX growth has already accelerated... Read More
Korea is gearing up to expand its own homegrown domestically produced medical device business. The country is hoping to develop and export more of its own medical devices internationally. In an effort to do this, a few weeks ago, Korea’s MFDS outlined... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices that utilize digital technology like AI, Big Data, and some software applications. The MFDS also said... Read More
Drug prices in Korea, like other markets around the world, have seen drug price erosion. Korea’s MOHW, earlier this year, established a private-public working group to discuss increasing reimbursement for innovative drugs. The goal of the Korean group is to foster new... Read More
Last month, officials from Korea and the US issued a Memorandum of Cooperation (MoC) on AI used in medical and healthcare products. According to the MoC, the two countries will try and harmonize regulations on AI medical products. The Korean government also... Read More
Up until 10 years ago, very few phase 1 studies were done in Asia. With limited drug R&D capabilities, new drugs mostly came from the US and EU. According to a recent report by Novotech, the last ten years have seen a... Read More
While telemedicine is now common in the West, it is also now growing in Asia. Some Asian countries recently outlined new telemedicine regulations. For example, Taiwan’s MOH recently announced draft amendments to their initial telemedicine regulation of 2018. Originally, telemedicine was to... Read More
While still behind the US and EU CDx markets to date, over the next 5 years, more and more CDx’s will be registered and used for precision medicine in Asia. Drug companies doing clinical trials and launching new drugs in Asia will... Read More
In late 2022, the Korean Pharma Association did an evaluation of over 200 drugs that were approved in Korea between 2011 – 2022. Western countries and Japan have been able to reduce the review times for new drug approvals, but during this... Read More