Drug approval reform can boost innovation

Time: 2015-11-17

Source: China economic times

Drug approval reform in strict new drug approval at the same time, encourage Chinese medicine new medicine, Chinese medicine innovation or usher in new opportunities.

Released recently, total bureau of national food and drug supervision and administration on the solution for drug registration backlog for priority review approval opinion (draft) ", the draft said that in order to strengthen the drug registration management, solve the contradictions of the current backlog of drug registration, make full use of the review of resources, speed up has clinical value for urgent clinical needs by new drugs and generic drugs research and development of the listed.

Among them, the new drug registration situation includes: not publicly listed company in China sales of medicine and has significant clinical value of innovation; The prevention and treatment of AIDS, malignant tumors, the major infectious diseases, rare diseases and other diseases and there is no effective treatment for drug registration of disease; Embody traditional Chinese medicine treatment of superiority, and has clear clinical localization in major disease prevention and control of the application for registration of new drug of TCM. The draft will be included in the priority in the scope of the examination and approval of new drug of TCM, release to encourage the innovation of traditional Chinese medicine.

In our country, a long time has been widely criticized for examination and approval of new drugs. In accordance with the provisions, for example, new drugs, according to the clinical trial approval time is 60 days to 90 days. But in fact, most companies have to wait 1 year to get approval. Reporting guidelines is not clear and opaque, often for new drug research and development enterprise "confused", to a certain extent affect the drug innovation of our country.

Promulgated by the state council in August of this year, "about the opinions of the drug review of medical equipment examination and approval system reform", from the national level for the reform of drug approval unfolds. Drug approval reform will focus on improve the quality of drug approval, solve the backlog of drug approval, improve the level of generic drugs, encourage innovation, and improve the review approval from five aspects, such as transparency in order to promote the pharmaceutical industry innovation and transformation and upgrading.

At present, China's drug innovation problems of the new drug is not "new" on the one hand, on the other hand also face the shortage of traditional Chinese medicine (TCM) innovation problem. The so-called new drugs is the vast majority of generic drugs, and the proportion of new drug of TCM is very small. According to the state drug supervision administration web site data, nearly 3 years of drug approval, according to the annual report 2012-2013, the number of traditional Chinese medicine (TCM) approved 27 and 37, respectively, only about 6% of the total number of the new drug. In 2014 approved 501 new drug approval, only 11 Chinese medicine, accounted for only 2.19%.

For examination and approval of the medicines reform drug standard by the current "not on sale in the territory of China medicine" to "not publicly listed company in China sales of the drug". This means that the listed abroad and at home has not yet listed medicines, is no longer belong to the scope of the new drugs, this change has greatly raised the threshold of the new drugs to declare. In addition, the drug of encouraging clinical value oriented innovation comes from ancient classic square compound preparations, simplify approval, etc., these policies will be conducive to further research and development innovation has the positive effect of traditional Chinese medicine (TCM).

To the Nobel laureate professor tu develop artemisinin to treat malaria, for example, artemisinin is on the basis of traditional Chinese medicine, after selection, extraction, separation, refining and purification of effective components development of traditional Chinese medicine, it is different from traditional Chinese medicine. Artemisinin is, as it were, with chemical medicine characteristics of modern Chinese medicine.

Should see, classic square is China's traditional Chinese medicine for the precious heritage of the modern human, to the health of the Chinese nation have made great contribution, is rare Chinese traditional medicine innovation resources. In recent years, the state has staged a series of promoting independent innovation and modernization of traditional Chinese medicine support policy, Chinese traditional medicine industry has become one of the highly independent innovation potential of the industry in China.

Internationally, plant medicine is more and more get the favour of people, Europe and the United States and other countries will also plant medicine into therapeutic drugs. Predictably, with the development and progress of science and technology, an aging population and the emergence of some new difficulty miscellaneous disease, people no longer rely on a single composition and synthetic drug prevention and treatment of diseases, the demand for Chinese herbal medicine, such as plant medicine will increasingly urgent, it also brought opportunities for the development of traditional Chinese medicine (TCM) industry in China.

But must also see that most of the Chinese traditional medicine is currently on the market at an early age to develop products, the backward production technology, quality control level is low, the serious lack of basic research and standardization of clinical research, seriously affected the further develops, the clinical use of traditional Chinese medicine (TCM) and market needs, in accordance with the international drug standard, to Chinese medicine research and development, the innovation for the center with disease.

At present, the basic research of TCM, TCM modernization level is also rising. The separation and purification of Chinese medicine effective component, effective parts has gradually become a conventional technology. Separation and purification of effective parts or active ingredients, to remove invalid, inefficient or toxic ingredients, lower doses, has become the inevitable trend in the development of modern traditional Chinese medicine (TCM).

The drug approval reform to encourage innovation, Chinese traditional medicine to promote our country's traditional Chinese medicine research on the path of more scientific, standardized, will help improve the overall level of development of new drug of TCM. But also unavoidable, the most traditional Chinese medicine research work is still very weak, the basis of its chemical composition, mechanism of action and process remains to be further studied in vivo, traditional Chinese medicine (TCM) innovation still has a long way to go.