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
On March 25, the National Medical Products Administration (NMPA) and National Health Commission (NHC) officially published the 2025 edition of the Chinese Pharmacopoeia. This new edition contains both traditional Chinese medicines and Western medicines and was reviewed and approved by the 12th... Read More
In March and April 2025, China’s National Health Commission (NHC) published its first formal guidelines on human genetic resources (HGR) after it took over the regulatory oversight of HGR from the Ministry of Science and Technology (MOST) last year. The introduction of... Read More
On March 19, China’s NMPA promulgated the draft – Interim Implementation Regulations for Drug Trial Exclusivity – with feedback expected by May 18. A similar draft was implemented in 2019, but not put in place due to industry objections. Data exclusivity will include independently... Read More
Everyone knows that it is getting tougher and tougher to export medical devices to China. While some companies with unique devices are succeeding and making large profits, many companies are not. Unprofitable Western business is a result of a number of factors including... Read More
According to the Drug Information Association (DIA), the Chinese pharmaceutical market is still expanding rapidly, as the National Medical Products Administration (NMPA) approved 84 new drugs in 2024, 12% higher than in 2023 and way more than the 50 novel medicines approved... Read More
The Insurance Association of China (IAC) is fast-tracking the proposal for a standardized Commercial Insurance Drug Catalog, which marks a major change in routes of funding for innovative medicines. The IAC, which is an important organization in the self-regulation of the industry, has set... Read More