Analysis And Strategies On The Post-market Safety Evaluation System For Injectable Traditional Chinese Medicine Formulations

Injectable Traditional Chinese Medicine(TCM) formulation originated in1950s in China. After many years’development, its gross annual market has risen to17billion RMB, constituting an important part of our national drug supply. However, with the emergence of various adverse effects associated with TCM injectables, its safety has become a major concern for the general public. The problems associated with TCM injectables include poor quality, discrepancies in specifications, huge number of low-quality manufactures and imprudent clinical application, where not all may be attributable to product quality or benefit-risk consideration. Hence, there is a need for a scientific and reasonable post-market evaluation system for injectable TCM formulations for its organic growth and development.Current study stated the history and current use of TCM injectables, along with its various problems. The author clearly stated the important value and irreplaceable role of TCM injectables to the current drug supply system of China. Based on the specialties of TCM injectables in material control, intermediate control, sterilization and product quality control, this paper further demonstrated the gaps between the legacy evaluations system with an ideal one. Through rationing and benchmark analysis, along with the series files on post-market safety evaluation strategy on TCM injectables put forth by SFDA from2009, this paper develops an ideal strategy in post-market evaluation on TCM injectables.The author deems that an ideal evaluations strategy on TCM injectables should be built on the gold principles on pharmaceutical evaluation-safety, effectiveness and controlled quality, where problems specific to TCM injectables could be further emphasized. With a review of the entire TCM injectables post-market evaluation campaign since2009, this paper states the value and positive effects of its actual operation. Provincial experience in implementing the campaign, along with case studies underpins the great value of the current new evaluation strategy. Current paper offers a preliminary analysis on the review of current evaluation strategy of TCM injectables. It is also valuable to the formation of a long-term growth strategy of TCM injectables.