Under the win-win environment of "raw materials + preparations", leading enterprises may benefit

[pharmaceutical Station industry trends] pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations, which have the important functions of improving drug stability, solubilization, solubilization, slow and controlled release The market of pharmaceutical excipients in China has broad development space According to the prediction of relevant data, the pharmaceutical excipients industry in China will reach 70-130 billion yuan in the future But in the past, the situation of "heavy API, light excipients" appeared in the development of pharmaceutical preparations in China, which seriously affected the development of pharmaceutical excipients industry, and also caused frequent quality problems of pharmaceutical preparations In this regard, the state's attention and regulatory power to pharmaceutical excipients industry gradually increased For example, as early as November 30, 2017, the former State Food and Drug Administration issued the announcement of the General Administration on adjusting the review and approval of APIs, pharmaceutical excipients and drug packaging materials, marking that China's raw excipients and preparations officially entered the era of related review According to relevant laws and regulations of Association review, if a listed pharmaceutical preparation changes its original auxiliary package supplier, the drug listing license holder (drug manufacturer) shall conduct research in accordance with relevant guidelines to prove that the change will not have adverse effects on the quality of the drug, and shall apply to the drug review center for Association review If the review fails, the supplier cannot be replaced This also means that it is more difficult to change suppliers For another example, in order to improve the quality of pharmaceutical excipients, Pharmacopoeia 2020 proposed to further strengthen the control of the safety of pharmaceutical excipients, which is consistent with the relevant international requirements, such as further strengthening the quality control of animal derived excipients According to pharmacopoeia 2020, the quality control of pharmaceutical excipients from animal sources should involve raw material collection, transportation, production, storage, circulation, use and other links Generally, comprehensive quality research and stability research should be carried out for raw materials, intermediates and key products, and the whole process quality traceability system should be established At present, the preparation of the first draft of the general principles of the four parts of Chinese pharmacopoeia in 2020 has been completed The industry said that the new pharmacopoeia will be of great significance for the improvement of pharmaceutical quality It is understood that the new pharmacopoeia also puts forward new standard requirements for the high-quality development of pharmaceutical excipients, and the market of pharmaceutical excipients may receive more and more attention At the same time, China proposes to improve the construction of the standard system of pharmaceutical excipients, increase the collection of the standards of commonly used pharmaceutical excipients, and promote the renewal and upgrading of the varieties of pharmaceutical excipients For example, on April 1, the State Pharmacopoeia Commission issued information that 11 standards for pharmaceutical excipients, such as l (+) - tartaric acid, would be included in the Chinese Pharmacopoeia 2020 In addition, the implementation of policies such as generic drug consistency evaluation, related review and approval, and volume purchase will also make the market environment of pharmaceutical excipients more standardized For this reason, the market of pharmaceutical excipients in China may be expanded rapidly, and the industry concentration will be further improved   With the gradual increase of the national attention to the pharmaceutical excipients industry, and the gradual promotion of regulatory policy reform in various links such as drug development, production, circulation and use, the situation of "small disorder" in the domestic pharmaceutical excipients industry has improved The related review requires that the finished drug enterprises should be responsible for and traceable to the quality and safety of pharmaceutical excipients, which also forces the finished drug enterprises to choose to have one Pharmaceutical excipients enterprises with fixed scale and technical strength shall conduct in-depth cooperation to ensure the quality and safety of excipients Market participants believe that under the win-win environment of "raw materials + preparations" gradually formed in the deepening reform of the pharmaceutical industry, leading enterprises in related industries may benefit.