NMPA CDE issues guidance on common formats for manufacturing processes and quality standards of Chinese medicines, chemicals and biological products

On July 19, 2021, the Center for Drug Evaluation of the NMPA released the "Common Formats and Writing Guidelines for Manufacturing Processes and Quality Standards of Chinese Medicines, Chemical Drugs and Biological Products". The notice of the guideline is as follows; the attachment documents of the guideline can be downloaded from the official CDE website (www.cde.org.cn).

In accordance with the Measures for the Administration of Drug Registration (Order No. 27 of the State Administration for Market Regulation), and to standardize the submission of application materials, under the deployment of the NMPA, the CDE organized the formulation of the "Common Formats and Writing Guidelines for Manufacturing Processes and Quality Standards of Chinese Medicines, Chemical Drugs and Biological Products" (see Attachments 1-3). Upon review and approval by the NMPA, it is hereby released and takes effect from the date of release.

From the date of release of this document, for drug registration applications submitted by applicants that involve the approval of manufacturing processes and quality standards, the manufacturing processes and quality standards shall be written in accordance with the common formats in the attachments. For varieties under review involving the approval of manufacturing processes and quality standards, where the applicant has not yet contacted or is in contact with the Center, approval shall follow the common formats in the attachments; where contact has been completed, review and approval may continue under the original common formats.

It is hereby notified.

Attachments: 1. Common formats and writing guidelines for manufacturing processes and quality standards of Chinese medicines; 2. Common formats and writing guidelines for manufacturing processes and quality standards of chemical drugs; 3. Common formats and writing guidelines for manufacturing processes and quality standards of biological products.

Center for Drug Evaluation, NMPA. July 15, 2021.