Buchang Pharmaceutical pointed out that Danhong injection is a traditional Chinese medicine injection produced by Shandong Danhong Pharmaceutical Co., Ltd., a subsidiary of the company. Before listing, it was approved by the state and obtained the Drug Registration Certificate on June 30, 2002 (approval number: Sinopharm approval word Z20026866).
Buchang Pharmaceutical said that the company has been continuously studying the life cycle of Danhong injection, including but not limited to the quality re-evaluation study of Danhong injection, the safety study of Danhong injection and the effectiveness study of Danhong injection.
According to the announcement, since 2009, the company's joint research institutions have cooperated with the First Affiliated Hospital of Henan College of Traditional Chinese Medicine and Shandong Adverse Drug Reaction Monitoring Center to conduct centralized monitoring and safety research on Danhong Injection after listing. Observe the inpatients who use Danhong injection, and the clinical pharmacist (the third party) will be the evaluator to observe the adverse reactions and evaluate the medical relevance. Solve the problem that the voluntary report of adverse reactions has no denominator, only examples, and cannot provide the evaluation of incidence and correlation. Combined with voluntary reporting information, product safety information can be better defined. * * * There are more than 40,000 inpatients who use Danhong injection.
Buchang Pharmaceutical said that the standards and guidelines for the effectiveness evaluation of traditional Chinese medicine injections have not yet been published, but the company took the lead in re-evaluating the effectiveness of the listed traditional Chinese medicine injections, objectively evaluated the efficacy of the products, gradually completed and published the relevant results, and further revised and improved the product specifications with the guidance and assistance of national regulatory agencies, industry experts and research hospitals.