According to the rules of Chapter V of Measure on the Approval of New Medicine, there are two stages in the application for and approval of new medicine: the clinical research stage and the manufacture stage. The application is examined by the appropriate provincial drug administration for primary auditing and by the National Drug Administration for final auditing and approval. The basic procedures and provisions for applying for new medicine are as follows.
1. Applicants are required to submit the Application Form for New Medicine Clinical Research or New Medicine Manufacturing, together with relevant data and samples, to the corresponding drug administration at the level of province, autonomous region, or municipality (for municipalities directly under the central government). The primary auditing will be performed by the provincial drug administration upon receipt of all source materials; and trial-manufacture conditions will be investigated on the spot in order to submit an investigation report. If the materials are complete, applicants will be informed officially that the application has been accepted. Meanwhile, relevant data and samples will be forwarded for further examination to the institute of drug control at the level of province, autonomous region, or municipality (for municipalities directly under the central government). If the materials are incomplete, application forms and relevant materials will be returned to applicant along with explanations of what is missing.
2. Application materials and inspection samples will be inspected by the institute of drug control at the level of province, autonomous region, or municipality (for municipalities directly under the central government) according to the procedures for requesting new medicine.
Auditing by the institute of drug control refers to the testing of new medicine and inspection samples for pharmacodynamics and toxicology (this might also include new inspection methods).
After auditing, the overall conclusion regarding quality standards in light of tests for pharmacodynamics and toxicology will be provided by institutes of drug control of the provincial drug administration.
3. The provincial drug administration will write the conclusions of the qualifying case on the Application Form for New Medicine Clinical Research or New Medicine Manufacturing. This form and relevant materials (along with five copies) will be sent for format auditing to the Registration Department of the National Drug Administration. Applicants concerned with new biomedicine and new medicine listed in Article 26 of the Measure on Approval of New Medicine are required to submit an application form and forward relevant materials (along with five copies) to the Registration Department of the National Drug Administration. Samples inspection and quality standard rechecking will be executed by the National Pharmaceutical and Biomedicine Testing Center.
4. Document format auditing is authorized by the Registration Department of the National Drug Administration; and the applicants are required to pay an examination charge. Meanwhile other relevant materials will be forwarded for technical evaluation, committee evaluation, and other necessary evaluation to the Center for Drug Evaluation. Applications that are disqualified by format auditing will be returned to the applicants.
5. After technical evaluation, the recommendation approval or rejection of the applicant will be forwarded to the Registration Department of National Drug Administration,
6. Application for new medicine clinical research will be approved by the director of the Registration Department of the National Drug Administration. Upon approval, clinical tests are processed by clinical test and research institutes chosen by the applicants.
7. Applications for new medicine manufacturing are approved by director of the Registration Department and then approved by the director general of the National Drug Administration. Putting new medicine quality standards and new medicine technology into practice is the job of the State Pharmacopeias Committee of china.
8. Relevant approval documents will be sent to the applicant.
(For reference only)