Korea is quickly expanding the use of AI in its drug regulatory and safety systems. Korea’s Ministry of Food and Drug Safety (MFDS) will start applying AI in drug review work starting next year as part of a wider attempt to innovate its regulatory... Read More
Registering a medical device in Korea involves navigating a stringent regulatory process governed by the Ministry of Food and Drug Safety (MFDS). While much has been written about Korea’s classification system and regulatory pathways, one critical aspect often overlooked is the documentation... Read More
Securing Korea Good Manufacturing Practice (KGMP) certification is a key regulatory milestone for medical device registration in Korea. The KGMP system, overseen by the Ministry of Food and Drug Safety (MFDS), ensures that medical devices are consistently produced and controlled according to... Read More
Western drug companies are demanding improvements to Korea’s “Innovative Company” criteria. Up until now, the Korean government has been choosing innovative firms every two years. Since the program started, there have been 49 designated innovative drug companies, but only 4 of these were... Read More
The Korean Ministry of Food and Drug Safety (MFDS) has introduced a new initiative focused on three aspects: organoid alternatives to animal testing, legal framework for CDMOs, and the acceleration of GMP inspections. First, the Bio Future Development Council will establish regulations... Read More
Introduction In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia,... Read More
Asia’s growing healthcare needs and aging populations offer a significant opportunity for medical device manufacturers from around the world. However, market access to the biggest economies in Asia – China, Korea, and Japan – usually entails navigating complicated and rapidly changing reimbursement... Read More
As global drug companies look to expand into Asia, having insight into the drug market access environment in China, Korea, and Japan is more important than ever. Although the drug registration procedure is getting less complicated in these markets, market access in... Read More
In the international pharmaceuticals industry, Good Manufacturing Practice (GMP) compliance is a fundamental foundation for the safety, quality, and efficacy of drugs. With expanding supply chains and more complex global partnerships, knowledge of the quality compliance environments of leading Asian pharmaceutical markets... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More