Promote product upgrading and play the role of "supporting role" of pharmaceutical excipients

[China Pharmaceutical network industry trends 】Pharmaceutical excipients refer to the general designation of all ingredients except the main drug In addition to shaping, acting as carrier and improving stability, pharmaceutical excipients also have important functions such as solubilization, solubilization, slow and controlled release, which may affect the quality, safety and effectiveness of preparations Pharmaceutical excipients must meet the pharmaceutical requirements in production, storage and application On November 30, 2017, the State Food and Drug Administration issued the "announcement of the General Administration on adjusting the review and approval items of APIs, pharmaceutical excipients and drug packaging materials (No 146, 2017)", which made it clear that pharmaceutical enterprises are mainly responsible for the selection of pharmaceutical excipients, which means that the excipients enterprises will fully accept the review of pharmaceutical enterprises to obtain the approval of pharmaceutical enterprises The announcement will promote the development and innovation of excipients enterprises, promote the promotion and application of new products, new dosage forms and new processes, and the development of pharmaceutical excipients market is full of infinite opportunities According to the statistics of relevant data, the market scale of pharmaceutical excipients calculated by the output value of pharmaceutical preparations in 2016 was 133.1 billion yuan, an increase of 23.2% year on year At present, China's pharmaceutical excipients industry has made great progress However, due to the late start and low overall level of pharmaceutical excipients in China, the proportion of domestic pharmaceutical excipients in the whole drug is still low, generally considered to be about 3% - 5% Nowadays, pharmaceutical enterprises have an urgent need for high-quality pharmaceutical excipients, which also urges domestic pharmaceutical excipients and drug packaging materials enterprises to actively adjust, improve product quality and ensure drug quality and safety Some experts said that with the gradual improvement of the regulatory system of the pharmaceutical excipients industry in China, the significant improvement of the quality and safety level of drugs, especially the development of the industrial production of drugs, the technology, process and quality of pharmaceutical excipients must be matched However, the slow development of new drugs and the transformation from drug development to new dosage forms will also promote the rapid improvement of technology, quality and varieties of pharmaceutical excipients For example, Chongqing stackelydenmeier Materials Technology Co., Ltd has chosen to innovate first, and because the innovation has improved the product quality, it has attracted international enterprises in the pharmaceutical excipients industry to establish joint ventures with them, and has rapidly opened up the global market "We chose to invest at that time, and we also liked their willingness to take the road of independent research and development, benchmarking international standards, and improving the level of domestic pharmaceutical excipients enterprises." Chongqing Science and Technology Venture Capital Co., Ltd Pharmaceutical excipient is a kind of carrier, at the same time, it can help to achieve different functions of drug release and controlled release In order to promote the better use of pharmaceutical excipients in drug production, China needs to constantly improve the level of pharmaceutical excipients enterprises It is understood that in order to promote the upgrading of pharmaceutical excipients, China has issued a number of policies For example, according to the 13th five year plan for national drug safety, the state will strengthen the supervision of pharmaceutical excipients and drug packaging materials, explore the establishment of a system for the review and approval of the relationship between pharmaceutical excipients, drug packaging materials and drugs with key quality risk control as the core and record management as the means China Pharmacopoeia 2020 will further strengthen the control of the safety of pharmaceutical excipients and drug packaging materials, and keep consistent with the relevant international requirements At the same time, we will increase the collection of standards for commonly used pharmaceutical excipients and key drug packaging materials, and promote the upgrading of pharmaceutical excipients and drug packaging materials Drugs are essential in our life, and drug safety is more directly related to our health Although pharmaceutical excipients only play the role of "supporting role", their quality can not be ignored With the promotion of policies, the quality of pharmaceutical excipients will be further improved Some experts said that in order to ensure the smooth implementation of the related review and approval system for pharmaceutical packaging materials and pharmaceutical excipients, the national pharmacopoeia committee will further strengthen the establishment and improvement of the pharmacopoeia standard system for pharmaceutical excipients and pharmaceutical packaging materials, and strengthen the formulation of relevant Pharmacopoeia standards In the future, the work of formulating the national standards for drug packaging materials and pharmaceutical excipients will focus on the establishment of the pharmacopoeia standard system, focusing on the formulation and improvement of the technical requirements related to drug packaging materials and pharmaceutical excipients, and the specification of the standard style.