The effectiveness and safety evaluation of traditional Chinese medicine injections

At the 28th meeting of the Standing Committee of the Twelfth National People’s Congress held on June 22, the National People’s Congress Deputies Committee heard and deliberated the State Council’s report on drug administration. Commissioned by the State Council, Bi Jingquan, director of the State Food and Drug Administration, made a report.

The report mentioned that China has basically eliminated the backlog of drug registration applications, and the number of drug registration applications waiting for review has dropped from 22,000 at the peak of 2015 to 6,000. Among them, applications for clinical trials of chemical drugs and vaccines, and various types of registration applications for traditional Chinese medicines have been reviewed and reviewed within a time limit, and about 15,000 drugs have been approved for marketing.

However, the current low-level duplication problem of China’s pharmaceutical industry is prominent. First, the homogeneity of medicines is serious. There are now 15,000 drug varieties in China, corresponding to 168,000 approval document numbers. There are 161 varieties with more than 100 document numbers, and 90 varieties with 50-100 document numbers. , The most variety document number reaches more than 800. The second is the serious shortage of investment in drug research and development. The report pointed out that in 2016, the investment of national pharmaceutical companies was less than the research and development funds of the world’s largest pharmaceutical company.

In the field of pharmaceutical production, the traditional Chinese medicine injections approved for marketing in the early stage still have safety and quality risks. The State Council stated in the report that injections, especially the injections produced from traditional Chinese medicines that were approved for the market early, have weak basic research on safety and effectiveness. Some manufacturers cut corners, use fake and inferior raw materials, and change production processes without authorization, which have seriously affected the drugs. The safety and effectiveness of the product.

Therefore, in the next step, the State Council proposes to establish a monitoring system for manufacturers to directly report adverse reactions, and to advance the effectiveness and safety evaluation of listed traditional Chinese medicine injections in phases and batches.

In the field of drug circulation, the problems of “small, scattered, and chaotic” in wholesale enterprises are prominent. Some pharmaceutical logistics and distribution companies have untrue and incomplete purchase and sales records, fictitious flow, separation of invoices and goods, and ticket sales, and other illegal and illegal operations have been repeatedly prohibited.

Behind the above-mentioned problems are deep-seated reasons such as the incomplete system and policies to encourage drug innovation and the difficulty of drug regulatory capabilities to meet the needs of industrial development.
Take the drug innovation system as an example. Only after the completion of phase I clinical trials in foreign drug innovation research can it be granted to China to apply for phase I clinical trials. In addition, China has adopted an approval system for Linchuan trial institutions, which limits the effective use of clinical resources to a certain extent.

In addition, the drug management law cannot fully meet the needs of development, which is also one of the important reasons.

The report points out that the basic system framework of the current Drug Administration Law was formulated 16 years ago. It is recommended to make necessary adjustments based on actual needs and changes in development concepts, further strengthen process supervision, strengthen the main responsibility of enterprises, and improve the consequences and adverse effects of drug violations. Matching punishment measures.

The report also revealed that the Drug Administration Law has now formed the third draft of the revised draft, which will be submitted to the State Council for deliberation in the second half of this year.