On April 2, 2024, China’s Center for Drug Evaluation (CDE) released the two draft guidelines:
Chemical, Manufacturing, and Controls (CMC) Self-evaluation Reports on Class 3 Chemical Drug Registration Applications (Drug Substance)
Chemical, Manufacturing, and Controls (CMC) Self-evaluation Reports on Class 3 Chemical Drug Registration Applications (Drug Product)
Class 3 drugs refer to Chinese drug products, whose originator versions have been granted marketing authorization only outside China.
Related: China Chemical Drug Registration Classification
The two drafts are intended to provide applicants with instructions for writing self-assessment reports on registration application dossiers for class 3 drugs. The goal is to improve the quality of the dossiers.
For example, in the self-assessment for drug substance’s filing, the applicant should ensure the name of the active pharmaceutical ingredient (API) is consistent with that in the national drug standards or the generic name specified in drug registration standards. If the API is not in these standards, the applicant should submit a generic name certification document or generic name verification application along with the API filing dossier.
Regarding the finished dosage form registration self-assessment, the applicant should select appropriate reference drugs from the Catalog of Reference Listed Drugs (RLDs). If the marketing authorization holder or the manufacturing country/region of the selected reference drug differs from that in the RLD Catalog, the applicant should evaluate the appropriateness of the selected reference drug.
The contents of self-assessment are basically consistent with ICH M4: The Common Technical Document and are presented in Table 1 and Table 2. The drafts will remain open for consultation until April 30, 2024. If you would like to know more details about drug registration in China, please contact BaiPharm.
Table 1: Contents of CMC Self-evaluation Reports on Class 3 Chemical Drug Registration Applications (Drug Substance) |
3.2.S.1 General Information 3.2.S.1.1 Nomenclature 3.2.S.1.2 Structure 3.2.S.1.3 General Properties 3.2.S.2 Manufacture 3.2.S.2.1 Manufacturer(s) 3.2.S.2.2 Description of Manufacturing Process and Process Controls 3.2.S.2.3 Control of Materials 3.2.S.2.4 Controls of Critical Steps and Intermediates 3.2.S.2.5 Process Validation 3.2.S.2.6 Manufacturing Process Development 3.2.S.3 Characterization 3.2.S.3.1 Elucidation of Structure and Physicalchemical Characteristics 3.2.S.3.2 Impurities 3.2.S.4 Control of Drug Substance 3.2.S.4.1 Specification 3.2.S.4.2 Analytical Procedures 3.2.S.4.3 Validation of Analytical Procedures 3.2.S.4.4 Batch Analyses 3.2.S.4.5 Justification of Specification 3.2.S.5 Reference Standards or Materials 3.2.S.6 Container Closure System 3.2.S.7 Stability 3.2.S.7.1 Stability Summary and Conclusions 3.2.S.7.2 Post-approval Stability Protocol and Stability Commitment 3.2.S.7.3 Stability Data |
Table 2: Contents of CMC Self-evaluation Reports on Class 3 Chemical Drug Registration Applications (Drug Product) |
2.3.P.1 Description and Composition of the Drug Product 2.3.P.2 Pharmaceutical Development 3.2.P.2.1 Components of the Drug Product 3.2.P.2.2 Drug Product 3.2.P.2.3 Manufacturing Process Development 3.2.P.2.4 Container Closure System 3.2.P.2.5 Microbiological Attributes 3.2.P.2.6 Compatibility 2.3.P.3 Manufacture 3.2.P.3.1 Manufacturer(s) 3.2.P.3.2 Batch Formula 3.2.P.3.3 Description of Manufacturing Process and Process Controls 3.2.P.3.4 Controls of Critical Steps and Intermediates 3.2.P.3.5 Process Validation and/or Evaluation 2.3.P.4 Control of Excipients 2.3.P.5 Control of Drug Product 3.2.P.5.1 Specification(s) 3.2.P.5.2 Analytical Procedures 3.2.P.5.3 Validation of Analytical Procedures 3.2.P.5.4 Batch Analyses 3.2.P.5.5 Characterization of Impurities 3.2.P.5.6 Justification of Specification(s) 3.2.P.6 Reference Standards or Materials 2.3.P.7 Container Closure System 2.3.P.8 Stability 3.2.P.8.1 Stability Summary and Conclusion 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment 3.2.P.8.3 Stability Data |
