Breaking the dependence on import of pharmaceutical excipients and promoting the quality of drugs

[market analysis of chinapharma.com] the quality of drugs is related to the curative effect and affects people's health In recent years, with the opening of the second child policy, the aging of the population, the improvement of domestic drug demand and requirements, drug quality issues are more and more valued by the state, so it is urgent to improve drug quality and ensure drug safety The industry points out that from the perspective of pharmaceutical industry, the three key factors affecting the quality of drugs are APIs, pharmaceutical excipients and preparation process Among them, the domestic pharmaceutical excipients industry started late, the industry concentration was low, and the quality standard system was not perfect, which led to the relatively backward development and production of domestic pharmaceutical excipients The quality of pharmaceutical excipients products in the market was uneven varieties, while the pharmaceutical excipients mainly depended on imports, which restricted the quality level of domestic drugs In order to improve the quality of pharmaceutical excipients in China, the state pharmaceutical regulatory department attaches great importance to and gradually strengthens the supervision and management of pharmaceutical excipients industry, continues to improve the quality standard system of pharmaceutical excipients, and the pharmaceutical excipients industry in China is gradually developing towards standardization and standardization In the aspect of quality and safety of pharmaceutical excipients, the quality management of pharmaceutical excipients is becoming increasingly strict Among them, "the production quality management standard of pharmaceutical excipients" has carried out a more comprehensive and systematic standard for the quality control of pharmaceutical excipients In 2012, the former State Food and Drug Administration issued the relevant provisions on strengthening the supervision and management of pharmaceutical excipients, further strengthening the supervision on the production and use of pharmaceutical excipients In addition, the 2015 edition of Chinese Pharmacopoeia has further improved the quality standard requirements of pharmaceutical excipients in terms of variety collection, system improvement of standard system, and overall improvement of quality control level In terms of registration and evaluation of pharmaceutical excipients, China's food and Drug Administration implemented classified management and hierarchical registration of pharmaceutical excipients before 2016 In August 2016, the State Food and Drug Administration issued the announcement of the General Administration on matters related to the review and approval of drug packaging materials and pharmaceutical excipients, which made it clear that "the packaging materials, containers and pharmaceutical excipients in direct contact with drugs shall be reviewed and approved together with the drug registration application instead of being approved separately" Previously accepted applications for registration of drugs, drug packaging materials and pharmaceutical excipients shall continue to be reviewed and approved in accordance with the original provisions In terms of standards for pharmaceutical excipients, according to the Pharmacopoeia 2020 edition, the inclusion of standards for raw materials, Chinese medicinal materials and pharmaceutical excipients will be emphasized Among them, it is clearly proposed in the draft for comments to further strengthen and improve the pharmacopoeia standard system of pharmaceutical excipients and drug packaging materials, increase the collection of standards for commonly used pharmaceutical excipients and drug packaging materials, promote the collection of mature standards for new pharmaceutical excipients and drug packaging materials, and focus on strengthening the formulation of excipients for high-risk preparations (injection, eye preparation, inhalation preparation and animal source); promote drugs Renewal of auxiliary materials and drug packaging materials According to the industry, there are a large number of pharmaceutical excipients manufacturers in China, with fierce market competition Foreign pharmaceutical excipients manufacturers, such as Merck and other international excipients production giants, have entered the pharmaceutical excipients market earlier in China, and have a certain stable market share These large-scale pharmaceutical excipients enterprises, with their advantages of capital and technical strength, occupy a monopoly position in some product markets and obtain excess profits Therefore, if domestic pharmaceutical excipients want to compete with them, it is not smooth sailing, and the key factor is the improvement of standards In 2019, the revised draft of the national pharmaceutical excipients standard was publicized intensively, which shows that the pharmaceutical excipients industry in China is on the way of standardization In this context, whether the pharmaceutical enterprises can catch the fast train of pharmaceutical excipients industry and improve the level of drug quality will be the key to its transformation driven growth In addition, some people in the industry said that with the continuous improvement of the production quality management specifications and quality standards of pharmaceutical excipients, pharmaceutical enterprises need to meet higher quality requirements, the cost of investment will inevitably increase, and pharmaceutical enterprises need to manage reasonably in cost control.