在原“新药审批办法”的附件中没有制定《制备工艺研究的技术要求》,仅在原附件七《质量标准研究的技术要求》中,关于“制法”的内容及说明项下,从标准制定的角度对“制法”及其起草说明提出简略的要求,这不利于制备工艺研究的规范化。鉴于此,起草了本《制备工艺研究的技术要求 In the appendix of the original “Approval Methods for New Drugs,” the “Technical Requirements for the Preparation Process Study” was not formulated. Only in the original Annex VII “Technical Requirements for the Study of Quality Standards”, the content and description of the “Regulations” were developed from the standards. The point of view puts forward simple requirements for the “law” and its drafting instructions, which is not conducive to the standardization of the preparation process. In view of this, drafted the technical requirements of this preparation process study