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
PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn more. Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of... Read More
On December 12, 2022, the Ministry of Food and Drug Safety (MFDS) announced that they will resume KGMP on-site audits starting on January 1, 2023, for all Class 2, 3, and 4 devices for registration approvals in Korea. Over the COVID period,... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
Recently, the Korean Ministry of Food and Drug Safety (MFDS) issued new device renewal requirements. For renewals, the medical device in Korea cannot have had any serious adverse events, and there needs to be a production or import track record and documentation.... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) recently announced a new program titled – Global Innovative Products on Fast Track (GIFT) which is similar to the US FDA’s breakthrough therapy designation system. The GIFT program is in addition to the already... Read More