On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes” with Information on requirements for completing a Chemical Drug Change.

The guidance provides information on the basic requirements for application materials, formatting, and review process along with a few attachments: a self-check form and a reference list. The document is divided into 3 major parts, and this blog will cover the basic requirements and the decision of approval.

General Requirements:

  1. The application form should follow: (Provisions of Drug Registration) and (Measures for the Administration of Post-marketing Drug Changes) and etc requirements.
  2. The catalogue number and project numbers cannot change.
  3. The number of documents should be consistent with the number of applications, with at least one original copy.
  4. While filling the information, it should be accurate, complete, standardized, and should not be handwritten or corrected, and should meet the requirements of the filling of applications.
  5. The filing of the application has to follow the electronic filing software and be in the electronic/paper format of the “Drug Registration Application Disk Software”, to be in the latest version, in RVT electronic for, with appropriate code on the data check and to be consistent with the submitted electronic form, the application form and self-check forms should have stamps of the applicant or the Local Representative.

Application Decision:

  • Two forms of Acceptance Notification will be provided to the applicant and to be filed for applications that meet formatting requirements.
  • Applications that are not complete or do not meet legal requirements, the reason for the incompleteness should be informed to the applicant at once, and a Notification for Correction will be issued.
  • Applications that do not meet requirements will be issued a Not Accepted Notification with explanations.

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China's NMPA

China's NMPA regulates the registration of drugs, medical devices and cosmetics; as well as conduct strict review and approval for marketing of these products.

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