While China has dominated the headlines for new drug research and out-licensing to Western pharmaceutical companies, and will continue to do so in the future, Korea, too, is entering the new drug game. While historically Korean drug companies have mainly focused on making generic drugs, with increased government financial support, the establishment in early 2025 of the Korean National Bio Committee, and the reduction of new innovative drug development timelines, Korea is now increasing its new drug R&D pipeline and coming out with new research and early-stage drugs that are being licensed to the Western drug community. Companies like GSK, Janssen, and Amgen have recently licensed Korean drug products.
The Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organisation (CDSCO) have released a 180-page draft of the standard test protocols for 15 types of in-vitro diagnostic (IVD) devices, including dengue disease, malaria, influenza, Nipah virus, and COVID-19. The protocols will harmonize quality, safety, and performance testing according to India’s Medical Devices Rules, 2017. The public has until late August to respond. Repeat testing of test kits after they fail initial evaluation will be prohibited. Re-validation will have to be done after a three-month wait time and proof of improvements. This move aims to increase IVD diagnostic accuracy, encourage local manufacturing, and improve outbreak preparedness.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.