Medical network - on May 27, recently, the country issued the national adverse drug reaction monitoring annual report (2016), which reports about the adverse reaction of Chinese traditional medicine/event involving the number of proprietary Chinese medicine cases of suspected drug top five categories, respectively is Richard blood agent in promoting blood circulation to remove blood stasis drugs (29.7%), heat in the heat of poison (9.7%), benefit qi and nourishing Yin in medicine (8.5%), begin to understand the cool prescriptions (8.4%) and nourish the agent in the cool nourish medicine (6.0%). 

 

▍ Chinese medicine injection adverse reaction rate is high, safety evaluation is on the agenda again 

 

Delivery system according to the distribution, Chinese medicine adverse reactions/events in 2016 report, the injection 53.7%, compared with 51.3% in 2015 rose by 2.6%. 

 

More interesting is that in Chinese medicines, serious adverse reactions/events report, intravenous administration (85.8%), other injected accounted for 0.9%, oral medicine accounted for 12.1%, the other method (1.2%). 

 

It is no wonder that the CFDA earlier this year director jingquan attended the press conference of the state council, to the Chinese and foreign media to release the CFDA in 2017, is the key to promote the first article mentioned the work of seven TCM injections safety evaluation work again - "accelerate the drug quality consistency evaluation of curative effect. 

 

Because, generic drugs on the market in China is the main body of clinical medicine, we should expand the resources of the clinical trials, explore the method of injection quality consistency and curative effect evaluation, to start the Chinese medicine injection drug safety, effectiveness and evaluation work. "It is also the first time since 2009 that we will reevaluate the safety of traditional Chinese medicine injections. 

 

▍ TCM injections growth started to show 

 

A total of more than 200 million brands have been found by the company's annual report, bond issuance report, and the Internet and other public data. 

 

Disease of heart cerebrovascular disease (16), tumor (6) and (5) the respiratory system disease is TCM injections "lucky", is the cradle of Chinese medicine injection big brands. 

 

From the point of sales revenue in 2016, though most brands or growth, but weakness all show that 29 brand of rise, though there are still 17, but growth is the highest is less than 17%, with only two in more than 15%, there were 11 under 10%; 

 

The decline of brands, combined with 12, fell by more than 30%, and by more than 18%, the decline was strong. 

 

 

 

Note: the data is derived from the annual report of the listed companies, as well as the estimated data from the public data. According to the sales revenue, the size of the sales figures is different from the sales figures for the listed price and the retail terminal price. Data for reference. 

 

▍ regulatory overweight, many traditional brands sales will be blocked 

 

In recent years, China has taken more concrete measures for medical reform. Among them, reduce the medicine proportion, strengthen the supervision of adjuvant and so on are the specific means, especially several provinces developed auxiliary drug monitoring directory, many of which are proprietary Chinese medicine injection, and great variety. 

 

In addition, the restrictions and regulations on the injection of Chinese medicine are fully reflected in the country's new health care directory released this year. 

 

Compared with the previous version of the medical insurance directory, the original marked clinical reimbursement constraints of all varieties of traditional Chinese medicine injection in the new health insurance directory, and add a number of varieties of traditional Chinese medicine injection clinical reimbursement limit conditions, as shown in the table below: 

 

 

 

▍ by evidence-based medicine/safety to evaluate the variety of the future or have a "second spring" 

 

Evidence-based medicine is to follow the scientific evidence of clinical medicine, advocate the clinician personal clinical practice and experience with objective evidence of scientific research, to the correct diagnosis and the most safe and effective treatment and the most accurate estimate in the service of each specific patients prognosis. 

 

In addition, the country has been advocating the promotion of the safety of traditional Chinese medicine injections and some manufacturers are moving forward. 

 

Still, there is a long way to go. Currently published technical document was published in 2010, including the principle of TCM injections to evaluate production process safety technology (try out) ", "Chinese medicine injection safety to evaluate quality control technology principle (try out)", "Chinese medicine injection safety evaluation principle of non-clinical research and evaluation technology again (try out)", and so on seven technical documents. 

 

However, the systematic evaluation method for the clinical use of TCM injectants in clinical use and safety reevaluation is still unreported. 

 

So far, publicly reported listed have been completed safety evaluation after a few of the traditional Chinese medicine injection prefer to marketing clinical research, experiment data and quality may not withstand the test. 

 

Some of the aforementioned TCM injection brands, the evidence-based medicine or the safety reevaluation are carried out as follows: