After the drug registration application is accepted, the Center for Drug Evaluation, NMPA (CDE) will notify the Center for Food and Drug Inspection of NMPA (CFDI) to start the registration verification within 40 days of the acceptance of drug registration application to start registration verification. The registration verification is to verify the authenticity and consistency of application materials and conditions for commercial production of the drug, and to check the compliance and data reliability of drug research and development. If you want to know more detailed registration on-site verification points and contents, please contact us by email or phone.
Factors Influencing Verification Initiation
| Variety Factors | High Risk | Innovative chemical drugs and improved new drugs |
| Innovative traditional Chinese medicines and improved new drugs | ||
| Biological products (except in vitro diagnostic reagents) | ||
| Traditional Chinese medicine injections | ||
| Varieties that adopt innovative processes or introduce new technologies into conventional processes | ||
| Other varieties that the CDE considers should be included in high-risk situations | ||
| Medium Risk | Complex dosage forms such as liposomes, microspheres, microemulsions, long-acting or sustained-release preparations, and inhalation preparations | |
| Special varieties such as synthetic peptides, multi-component biochemical drugs, traditional Chinese medicines and ethnic medicines containing highly toxic medicinal materials in their prescriptions | ||
| Using unconventional sterilization processes, micro-tablet preparation, dry pressure coating and other complex processes | ||
| Other varieties that the CDE considers should be included in medium-risk situations | ||
| Low Risk | Except for the above-mentioned high and medium-risk variety factors, the others are all low-risk variety factors |
Compliance Factors for R&D and Production Entities
R&D and Production Entities
(1) Newly established enterprises or enterprises with no previous experience in the production of relevant dosage forms;
(2) The key data research institution supporting drug marketing has not received registration verification, supervision and inspection by domestic and foreign drug regulatory agencies in the past three years;
(3) Drug manufacturing enterprises (production lines and site facilities), key data research institutions and other institutions supporting drug marketing have failed registration verification and supervision inspections by domestic and foreign drug regulatory agencies in the past three years or have discovered authenticity issues, major defects, or major non-compliance issues;
(4) Drug manufacturing enterprises (production lines and site facilities), key data research institutions and other institutions supporting drug marketing have failed to pass the review of registration applications due to authenticity issues in the past three years, and have failed sample inspections;
(5) Drug manufacturing enterprises (production lines and site facilities), key data research institutions and other institutions supporting drug marketing are involved in withdrawing drug registration applications after receiving registration verification notices in the past three years;
(6) There are related relationships between clinical project research institutions (including clinical trial institutions, central laboratories, biological sample analysis and testing institutions, clinical trial site management organizations, etc., the same below) or with the sponsor;
(7) Other compliance factors for R&D and production entities that the CDE deems should be considered.
In principle, the risk level of the registration application will be determined based on the higher risk situation among the variety factors and the compliance factors of the R&D and production entities, except for special circumstances. For supplementary applications, biological products and traditional Chinese medicine injections are not included in high-risk variety factors.
