The formulation and revision of pharmaceutical excipients standards is more standardized, helping the high-quality development of the industry

[industry trends of pharmaceutical Station] on May 5, the Pharmacopoeia Committee issued a message saying that in order to further standardize the working procedures and requirements for the preparation and revision of pharmaceutical excipients standards in China Pharmacopoeia, the Pharmacopoeia Committee specially formulated the working specifications for drafting and review of national pharmaceutical excipients standards (for Trial Implementation)   According to the contents of the annex "national standards for pharmaceutical excipients drafting and review work specification" (Trial), the specification aims to encourage and regulate the holders of drug listing licenses (drug manufacturers), pharmaceutical excipients production enterprises, inspection institutions, educational and scientific research institutions, social organizations, etc to undertake or participate in the research of national standards for pharmaceutical excipients, and clarify the preparation and revision of standards for pharmaceutical excipients in Chinese Pharmacopoeia To formulate the qualification, responsibility and work flow of drafting and review unit According to the qualification requirements of drafting and review units, the drafting unit and review unit of the national pharmaceutical excipient standard formulation and revision research project shall have the qualification of an independent legal person or contracting entity, and at least one municipal or above inspection institution approved by the laboratory and having the pharmaceutical excipient standard formulation and Revision Test The drafting unit shall have technicians who are familiar with the technical development trend, production level and application requirements at home and abroad involved in the product standard, and understand the existing problems and solutions of the standard In addition, drug marketing license holders (drug manufacturing enterprises), pharmaceutical excipients manufacturing enterprises, educational and scientific research institutions, social organizations, etc can participate in the research work of national pharmaceutical excipients standard preparation and revision by providing standard research samples, validation data and suggestions According to the arrangement, the drafting work should be completed in 6 months generally, and can be extended to 8 months appropriately according to the workload Pharmaceutical excipients have important functions such as shaping, acting as carriers, improving drug stability, solubilization, solubilization, slow and controlled release, or affecting the quality, safety and effectiveness of preparations In the past, due to the phenomenon of "heavy API, light excipients" in China's pharmaceutical industry, the pharmaceutical excipients industry has not been attached great importance to, and because the industry itself started late, it is difficult to achieve high-quality development, accounting for a small space in the output value of pharmaceutical preparations In recent years, with China's pharmaceutical excipients industry gradually entering the development period, the scale continues to expand, but the whole industry is still small and scattered phenomenon, leading to frequent quality and safety incidents of pharmaceutical excipients, which also makes the pharmaceutical excipients industry get attention, its system and standard system need to be improved, and the supervision efforts need to be strengthened According to the public information, the author found that since 2019, the National Pharmacopoeia Commission has successively issued the draft standards for national pharmaceutical excipients As of April 25, there are 39 Public drafts related to the national standards for pharmaceutical excipients, involving more than 60 excipients It can be seen that China attaches great importance to the pharmaceutical excipients industry, and the formulation and revision of excipients standards are also speeding up The work specification for drafting and review of national standards for pharmaceutical excipients was formulated to standardize the working procedures and requirements for the preparation and revision of standards for pharmaceutical excipients in Chinese Pharmacopoeia Chinese pharmacopoeia is an important technical standard for the standardization and development of pharmaceutical excipients industry in China According to the industry, at present, there are more than 540 kinds of pharmaceutical excipients in use in China, and the standards of excipients in Pharmacopoeia are increasing With the implementation of China Pharmacopoeia 2020 in the near future, it will help the development of pharmaceutical excipients industry more standardized and accelerate the upgrading and transformation of the whole industry.