Management System Reform Speeding up

At present, China's pharmaceutical accessories R & D costs are high, there is an urgent need to improve the registration process, R & D investment output is relatively low, the lack of R & D initiative. The urgent task is to draw lessons from the experience of medical management in foreign countries, to speed up the reform of related management system.

First, from the point of view of the production level, Chinese medicinal materials production enterprises in more basic level, most stay in the stage of high energy consumption and low profit, there are few effort and money into the development of new varieties and technology research. Secondly, from the point of view of the production environment, the present stage of the production of medicinal materials and non pharmaceutical accessories compared to the policy does not have the advantage. New accessories to study the development of its safety and toxicity, to undergo a lengthy approval process, after the approval of the product promotion and market development and growth of the process. Enterprises registered pharmaceutical accessories to pay high costs, it is inevitable in terms of price competitiveness disadvantage, if there is no relevant support policies, it is easy to combat the enthusiasm of enterprises to develop new pharmaceutical accessories.

In fact, in the registration process we can learn from the United States DMF record management model, this registration system makes the registration efficiency of medicinal materials is very high, as long as 2 ~ 3 weeks. The excipients used in the application, the U. S. Food and Drug Administration (FDA) has a series of detailed provisions, such as in the United States Pharmacopoeia has developed quality standard accessories, new drug application does not need to provide quality information; if there is no income USP accessories or new materials, it is necessary to provide data on the safety of the application; for some have been used, but not income in the United States Pharmacopoeia accessories can also be declared according to other quality standards. For new accessories, manufacturers must refer to the "supplementary materials safety assessment guidelines" to provide security information, etc.. For the application of accessories imitation products, all ingredients must be listed in the FDA non active material database or auxiliary materials database. As the production of generic drugs does not need to do clinical research, and therefore the use of each adjunct must be less than the amount used, otherwise it is necessary to provide security information. At the same time, the FDA also established a drug reference file, medicinal materials production enterprises will be confidential information of their products put in for FDA inspection, not only can achieve confidentiality, also facilitate the FDA's review of the need.

China's drug regulatory departments approval and issue the approval number for accessories, be responsible for determining the materials can be used in the manufacture of the drug product, which in a certain extent limits the preparations of materials used, resulting in a lack of preparation production enterprise use new materials development a new formulation of active consciousness. At the same time, the domestic materials production enterprises because of free competition and the lack of enthusiasm for new materials development. Therefore, the country should give preparation production enterprise more choice and promote the enterprises to actively take the initiative to choose a wide range of medicinal materials, develop new medicinal materials in new drug preparations to try, to improve the level of development of Chinese medicine preparation. Of course, in order to ensure the quality of drugs preparation production enterprise, promote the use enterprises to actively take the initiative to choose new materials and accessories, and drug regulatory authorities also need to further strengthen the preparation production enterprise, sense of responsibility, principle who used accessories who is responsible for and asked responsibility materials production enterprises and enterprises. It can supervise the preparation of production, can also hold the quality accessories products.

In the administrative management system, the relevant departments of the State shall be reference DMF management mode in the United States in summary based on China's material management experience and problems, for the establishment of China's regulatory and enforcement of medicinal materials for the record system. This can not only shorten the registration period, improve processing efficiency, saving the cost of examination and approval, and approval of materials evaluation can and drug combination, to effectively master drug production and was listed on the use of information to ensure supervision and inspection can trace to the source.

China's new materials generally can be divided into: was invented in our country or abroad, only the reported in the literature of pharmaceutical excipients (to be submitted pharmacology study, acute toxicity test, long term toxicity test, mutation test, reproductive toxicity, carcinogenic test data), the existing chemical substances for the first time employed as excipients in preparation (to be submitted to the pharmacological studies, acute toxicity test data, other information can be does not require), abroad has been approved and used in the preparation of pharmaceutical excipients, and existing food additives for the first time as the excipients used in formulation. At present, our country for the management of the new accessories is in accordance with the different requirements of the category of the corresponding information, but not on the specific ways of giving further classification of the drug. U. S. Food and Drug Administration (FDA) on the auxiliary further according to the route of administration of classification management, if the medicinal supplementary material application of the ultimate drug injection when administered, provide the pharmaceutical excipients do not have acute injection toxicity and safety test data; if the pharmaceutical excipients of the ultimate drug preparation via the skin or mucous membrane administration need to add to it in the position of evaluation of safety data. Through this classification management can more to ensure the safety of the application materials, the FDA will accessories used in short-term, short-term or medium-term repeated use, in the long-term repeated use of the different, in different route of administration of accessories to further requirements provide some additional data. Even if the enterprises save a lot of manpower and resources, and fully guarantee the safety of the public.