Related approval refreshes the selection mode of raw and auxiliary materials for pharmaceutical enterprises

Source: pharmaceutical economic report 2016-08-01 "the application for listing of APIs, pharmaceutical packaging materials and pharmaceutical excipients shall be reviewed and approved in connection with the application for listing of preparations or the supplementary application for listed preparations The original and auxiliary materials will no longer accept their listing application separately " At present, the administrative measures for the registration of drugs (Revised Draft) (hereinafter referred to as the "draft") which is in the process of public consultation has added a long-standing and far-reaching term of "related examination and approval" Liu Xuebin, general manager of Baiyunshan chemical pharmaceutical factory of Guangzhou Pharmaceutical Group Co., Ltd., told reporters: "I think the upstream and downstream pattern of the pharmaceutical sector will be reshaped Pharmaceutical companies will "hold the upstream resources more tightly" and become the first person responsible for product quality From this point of view, upstream API suppliers will have pain in the short term In the past, the company registered and applied by itself to meet the national standards, but in the context of generic drug consistency evaluation, the related approval indirectly improved the requirements of raw and auxiliary material product research and development technology level If we fail to meet the requirements, what we lose is not a customer, but an approval In the long run, the industry concentration will be accelerated and the service awareness of enterprises needs to be further enhanced " According to the industry insiders of the community of common destiny, "prior to the implementation of approval management for raw and auxiliary materials, chemical, food and other enterprises, which accounted for a large proportion, intensified industry competition." Related examination and approval will certainly restructure the industry pattern " In a deeper level, the industrial pattern of "low, small and scattered" raw and auxiliary materials industry in China needs to be broken Take Shanhe Pharmaceutical Co., Ltd., a leading enterprise, as an example In 2015, the revenue was 260 million yuan, the market share was less than 1% of the auxiliary industry, and the R & D investment accounted for 2.8% of the revenue These data are good in the auxiliary material industry, but also reflect the embarrassment of the auxiliary material industry in China Yin Zhenglong, chairman of Anhui Shanhe pharmaceutical Accessories Co., Ltd., felt the same "The domestic auxiliary material industry has developed rapidly in recent years, but it also faces great challenges For example, there are more than 500 kinds of auxiliary materials in use, but only about 300 kinds have standards, and a large number of varieties lack standards," he told reporters Compared with the separate declaration, the associated approval provides a fast channel for the declaration of new excipients, meanwhile, the audit of preparation manufacturers will be stricter, and good excipient suppliers will be selected In my opinion, the development of the industry comes from competition It's up to the pharmaceutical companies to decide which enterprise's excipients to use, so that the upstream and downstream cooperation will be closer " The consistency evaluation of generic drugs provides an opportunity for the upgrading of domestic excipients industry Pharmaceutical enterprises have changed from choosing low-cost drug accessories in the past to high-quality and stable drug accessories "Domestic raw and auxiliary materials have price advantages As long as the cooperation is in place, domestic raw and auxiliary materials can also assist the pharmaceutical factory to complete the consistency evaluation." Experts pointed out that preparation enterprises will pay more attention to and standardize the audit of raw and auxiliary materials enterprises, fully understand their standards, performance, production and other information, and ensure the quality of raw and auxiliary materials through strict and standardized supplier audit, and ultimately be responsible for the quality of drugs To this end, Liu Xuebin said bluntly: "in the past, the impurity research of generic drugs has a close relationship with APIs Strengthening the research of APIs is conducive for pharmaceutical manufacturers to comprehensively consider the impact of its safety and scientific prescription process on the quality of drugs Related approval enables the binding of APIs and preparations in advance In the past, only simple pharmaceutical research was done for APIs Now upstream enterprises and pharmaceutical enterprises are lips and teeth of each other, and they need to carry out two-way mutual assistance research closely " Previous documents mentioned that the regulatory authorities of the place where the drug registration applicant is located should strengthen the extended supervision of the packaging materials and auxiliary materials used for drugs This requires the implementation of remote supervision, raw and auxiliary materials and pharmaceutical enterprises linked together, more need to strengthen cooperation Quality competition is more specialized and refined At present, pharmaceutical preparations are developing in the direction of high efficiency, quick effect, long-term, small dosage and side effects, and pharmaceutical dosage forms are transforming into timing, positioning and quantitative drug delivery systems The new raw and auxiliary materials play a key role in this process "The overall trend in the future is to develop in the aspects of stronger functionality, less impurity residues and better stability Such as compound auxiliary materials "I think there are two shortcomings of domestic excipients that need to be strengthened: first, stability," Yin said At present, the stability of domestic pharmaceutical excipients varies greatly among batches, especially for polymer materials The research on their functional indexes is not deep enough In the context of the consistency evaluation of generic drugs, it is urgent to improve the stability of excipients At present, the main solution is to further improve the level of production automation and reduce manual operation, but this is still a problem for many small and medium-sized enterprises Second, refinement There are many different specifications for a excipient product in developed countries Different processes distinguish different performances However, no matter what preparation is made for the domestic excipient product, its specifications are very single China's auxiliary material industry started late, which requires the auxiliary material enterprises to further strengthen the research on the fluidity and compressibility of auxiliary material products, and refining will be the next development focus " If the pharmaceutical excipients have an impact on the stability of the API, it is necessary to conduct a study on the compatibility of the two FDA has clearly defined the maximum daily dosage of each excipients, which is also worthy of attention Some experts pointed out that the lack of communication between upstream and downstream enterprises is also a common problem in the industry, resulting in weak technical support and insufficient support for customers Compared with foreign products, the lack of competition between domestic raw materials and auxiliary materials has a lot to do with this According to Liu Xuebin“ The curative effect of generic drugs is the same as that of the original research drugs, which is reflected by the preparations If the preparation factory and the API factory belong to the same company, there is no such problem On the contrary, with the upgrading of the consistency evaluation of generic drugs, the preparation enterprises will select the raw and auxiliary materials of corresponding specifications according to their own varieties in the future, and the enterprises that can comply with the development trend of preparation technology are expected to occupy the future incremental market " He believes that pharmaceutical enterprises are ultimately responsible for the quality of drugs, and promote the purchase selection mode of raw and auxiliary materials to change from simple price selection to consideration of multiple factors such as technical support, quality stability and price In the future, the improvement of technology and quality will guide the market to redistribute