Dali Pharmaceutical Co.,Ltd

China Mandates Rigorous Clinical Trials for Traditional Medicine Injections in Historic Regulatory Overhaul

- China's National Medical Products Administration has released the strictest regulations ever written for traditional Chinese medicine (TCM) injections, requiring all products approved before 2019 to undergo rigorous post-market evaluations for safety and effectiveness. - Companies must conduct randomized controlled trials and generate complete clinical data within five years or lose their registrations, with compliance costs estimated at up to 40 million RMB per product. - Industry insiders predict that half to two-thirds of the 868 active TCM injection approvals will disappear, marking the end of an era for products that generated hundreds of billions in annual sales despite operating in a regulatory grey zone. - The reform follows decades of safety concerns, including patient deaths and severe allergic reactions, as these herbal extracts have long lacked the clinical evidence required for modern pharmaceuticals.