IPEC China Excipients Conference 2025 Concluded Successfully 2025-12-05

Copy: Notice on the Cancellation of CD-ROM Submission for Clinical Trial Database and the Update of Electronic Application Dossier Preparation Software 2025-11-20

Huang Guo Conducted an Investigative Research on the Management of APIs in Zhejiang 2025-11-20

XIZIMED Makes a Splash at the 93rd API China 2025-11-19

XIZIMED successfully participated in the 93rd China International Exhibition on APIs, Intermediates, Packaging, and Equipment (API China), held at the Chongqing International Expo Center in China on November 12-14, 2025.

Demonstration of Re-registration application dossier for overseas-produced APIs 2023-10-16

National Medical Products Administration issued the Announcement of NMPA on Relevant Issues of Re-registration Management of Chemical APIs on October 13, 2023(2023 No. 129).

Good news | Xizimed has passed ISO 9001 quality management system certification 2023-05-30

Through nearly a year of hard work and pioneering practice of all employees, Xizimed successfully passed the CQC ISO 9001 quality management system certification, providing a good guarantee for the quality of projects for new and old customers at home and abroad.

Copy | Notice on the Requirements for Submissions in Electronic Format of Drug Registration 2022-12-02

按照《 药监局关于实施药品注册申请电子申报的公告》（2022年第110号）要求，自2023年1月1日起，申请人提交的 药监局审评审批药品注册申请以及审评过程中补充资料等，调整为以电子形式提交申报资料，现就电子申报具体要求通知如下：

Copy | Announcement of NMPA on the Issuance of the Administration of Post-approval Changes to Drugs (Trial Implementation) (No. 8 in 2021) 2024-12-12

为贯彻《药品管理法》有关规定，进一步加强药品上市后变更管理， 药监局组织制定了《药品上市后变更管理办法（试行）》，现予发布，自发布之日起施行，此前规定与本公告不一致的，以本公告为准。各省级药品监管部门应当落实辖区内药品上市后变更监管责任，细化工作要求，制定工作文件，明确工作时限，药品注册管理和生产监管应当加强配合，互为支撑，确保药品上市后变更监管工作平稳有序开展。

Copy |Announcement of NMPA on the Re-issuance of the Fee Standards for Drug Registration (No. 75 in 2020) 2020-06-30

根据《药品注册管理办法》（ 市场监督管理总局令 第27号）、《关于重新发布中央管理的食品药品监督管理部门行政事业性收费项目的通知》（财税〔2015〕2号）和《关于印发〈药品、医疗器械产品注册收费标准管理办法〉的通知》（发改价格〔2015〕1006号）， 药品监督管理局制定了《药品注册收费标准》《药品注册收费实施细则》，现予公布，自2020年7月1日起施行。

Copy |Announcement of NMPA on Further Improving the Bundling Review and Supervision of Drugs (No. 56 in 2019) 2024-12-12

为落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》，原食品药品监管总局发布了《关于调整原料药、药用辅料和药包材审评审批事项的公告》（2017年第146号），现就进一步明确原料药、药用辅料、直接接触药品的包装材料和容器（以下简称原辅包）与药品制剂关联审评审批和监管有关事宜公告如下