Next year, we will launch a comprehensive post marketing reevaluation program

"Post market re evaluation is a general trend Enterprises should attach great importance to it, establish advanced concept of continuous innovation of old products, conduct product sorting, diagnosis and top-level design in advance, and timely carry out post market clinical evaluation." Wang Guihua, Secretary General of China Association of traditional Chinese medicine, said in an interview that the post marketing reevaluation of traditional Chinese medicine varieties can not only systematically evaluate the efficacy and safety of products, but also help to find new indications, which has a positive effect on medical insurance, pricing, bidding, academic promotion and adverse events Focus on efficacy and safety "in the pre market phase III clinical research, the sample number is still small, the time is short, some complications and drug interactions may not be shown, need large-scale, long-term re evaluation to verify the efficacy and evaluate the safety." Zhu Tongyu, vice president of Zhongshan Hospital Affiliated to Fudan University, said Since the re evaluation of the safety of traditional Chinese medicine injection was launched in China, some enterprises began to pay attention to the re evaluation of the clinical efficacy and safety of traditional Chinese medicine "Like most traditional Chinese medicine injections, there is no relevant research on the incidence of adverse reactions, population characteristics, influencing factors and other data of Shenfu injection, and the doctors and patients lack the basis for safe drug use." Relevant people of Cr 39 believe that enterprises should actively carry out safety re evaluation research after drug listing The safety re evaluation of Shenwei pharmaceutical Shenmai injection lasted nearly four years, collecting 30000 real world studies; the clinical safety evaluation of Danhong, Reduning and other large varieties of traditional Chinese medicine injection was also included in the national science and technology plan, and has been implemented In order to obtain more clinical data of safety and effectiveness, some manufacturers of other dosage forms of Chinese patent medicine have also explored the post market evaluation of some varieties "We focus on the safety and economy of traditional Chinese medicine." Zhang Chunbo, chairman of Baiyunshan Zhongyi Pharmaceutical Co., Ltd., told reporters that since 2007, the company has invested 10 million yuan in the post market clinical re evaluation research of Xiaoke pill and 5 million yuan in the pharmacoeconomic evaluation project Professor Ma Rong, Dean of the First Affiliated Hospital of Tianjin University of traditional Chinese medicine, suggested that the purpose of re evaluation study should be clear, and the scheme design should be distinguished from phase II and phase III clinical trials The scheme design of reassessment after the marketing of Chinese patent medicine should not only reflect the principles of safety, effectiveness and economy, but also conform to the national conditions, and play a guiding role in the follow-up development Wang Guihua specially pointed out that the research after the drug is put on the market can produce the chain benefit, which can not only promote the secondary development of the product, but also help to clarify the product positioning, obtain marketing support data, excavate new clinical indications, pharmacoeconomics research, etc., which enriches the value of clinical trials of drugs "It can also identify problems as early as possible, and provide solid research data to solve problems in the face of storms and disputes Pharmaceutical companies should have such a long-term vision " "Pharmacoeconomic research has confirmed that the daily cost of Xiaoke pill is 1.42-4.25 yuan, with an average of 2.84 yuan Compared with the commonly used oral hypoglycemic chemicals and traditional Chinese medicine, Xiaoke pill has a good potency ratio After the research of Xiaoke pill, the enterprise will evaluate Zishenyutai pill after it goes on the market, hoping to explore new indications " Zhang Chunbo introduced that these clinical research results can provide doctors with a large number of valuable evidence-based medical data It is worth mentioning that it is of great significance to reevaluate the Chinese patent medicine after it goes on the market in terms of medical insurance "The indications of traditional Chinese medicine are relatively broad, such as Yupingfeng powder or Yupingfeng granules The main ingredient is Astragalus However, the manufacturers make the indications of this medicine very large, involving 20 or 30 diseases." Some experts remind that "because it is difficult to classify specific diseases, in order to keep the selection of traditional Chinese medicine in the basic medicine and medical insurance catalog, Chinese medicine manufacturers should find the dominant diseases and provide clinical research data so as to reasonably classify the diseases by payment.