APIs are important substances in pharmaceutical production. The quality of pharmaceutical excipients is directly related to the quality of the drug. For a long time, pharmaceutical excipients have been included in China's drug categories and have been subject to strict management. The new "Pharmaceutical Administration Law" no longer includes "pharmaceutical excipients" in the definition of "drugs".Regarding the management of pharmaceutical excipients, the new "Pharmaceutical Administration Law" only stipulates that "when approving drugs, chemical raw materials should be reviewed simultaneously" and that "the production of unapproved pharmaceutical excipients, packaging materials, and containers" is prohibited. Overall, the new "Pharmaceutical Administration Law"'s regulations on the management of "pharmaceutical excipients" investigate and penalize "drugs produced using unreviewed and unapproved raw materials." The development, production, and operational requirements of APIs need further clarification in the "Implementation Rules of the Pharmaceutical Administration Law" or pharmaceutical management regulations.

To study the management of "pharmaceutical excipients", the basic first question is to scientifically determine the basic attributes of "pharmaceutical excipients", that is, whether "pharmaceutical excipients" are "drugs"? According to the original "Pharmaceutical Administration Law", "pharmaceutical excipients" belong to "drugs", but strictly speaking, they do not meet the definition of "drugs": "Drugs are used to prevent, treat, and diagnose human diseases, aiming to regulate the physiological functions of the human body, and provide indications or functional indications, as well as usage and quantity of substances." Because all "drugs" can be used directly, while "raw materials" cannot be used directly, nor do they have "specified indications." The new "Pharmaceutical Administration Law" aims to clarify the source, restore the essential attributes of "raw materials", and separate them from "drugs." This is a respect for the drug law.As mentioned earlier, "raw materials" are important substances in pharmaceutical production. To strengthen drug supervision, raw materials (3 provisions in the "Pharmaceutical Administration Law"), excipients (9 provisions in the Pharmaceutical Administration Law), and packaging materials (9 provisions in the Pharmaceutical Administration Law) must adhere to source management. There are 6 provisions regarding administrative organs and ion methods, 6 provisions regarding containers, etc. To achieve the "four strictest" requirements for drug safety, "raw materials" must be strictly managed according to law.