【正文】 plication dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of nonacceptance notification of drug registration application, with explanation of reasons.Article 52: PDA shall, within 5 days upon acceptance of the application, organize and conduct onsite inspection of the drug research and the original data, conduct preliminary examination of the application dossier. If the drug to be registered is biological product, PAD shall take sample drugs of 3 batches, and notify the drug control institute for inspection.Article 53: PDA should, within the prescribed time limit, submit the examination remendation, verification report and application dossier to the Center of Drug Evaluation of SFDA, and notify the applicant.Article 54: Drug control institute received the registration inspection notification should inspect the sample according to the drug standards submitted by the applicant, verify the drug standards, and submit the inspection report to Center of Drug Evaluation (CDE) of SFDA within the prescribed time limit, and copy applicant in.Article 55: Upon receipt of the application dossier, CDE of SFDA shall within the prescribed time, organize pharmaceutical, medical and other technical staff to conduct technical examination of the application dossier, and may request, with explanation of reason, the applicant to provide supplemental information and drug sample if necessary. After pleting the technical examination, technical examination remendation will be issued and submitted to SFDA along with the related application information. SFDA shall make approval decision based on the technical examination remendation. When SFDA consider the requirements are met, Approval for Drug Clinical Study will be issued. When SFDA does not consider the requirements are met, Notification of Approval Opinion will be issued with explanation.Section 2: Production of New Drug Article 56: After pletion of a clinical study, the applicant shall fill out the Drug Registration Form, and submit production application dossier to the PDA where the applicant is located. At the same time, the applicant shall submit the raw material and research data related to standard substance for the preparation of the standard substance to NICPBP.Article 57: PDA shall examine for form the application dossier, and if the requirements are met, the application will be accepted with issuing of acceptance notification of drug registration application. If the requirements are not met, the application will not be accepted with issuing of nonacceptance notification of drug registration application, with explanation of reasons.Article 58: PDA shall, within 5 days upon acceptance of the application, organize and conduct onsite inspection for the clinical trial and relevant original data, conduct preliminary review and issue examination remendation. For those drugs other than biological product, PDA should also need to take sample of 3 batches of the drugs, and notify the drug control institute to verify the standards.PDA shall, within the prescribed time limit, submit its remendations, inspection report and application dossier to CDE, and notify the applicant. Article 59: Drug control institute should verify the drug standards, and then submit the verification remendation to CDE within the prescribed time limit, at the same time, copy in the PDA that issued the notification to verify, and copy the applicant in.Article 60: Upon receipt of the application dossier, CDE of SFDA shall within the prescribed time, organize pharmaceutical, medical and other technical staff to conduct technical examination of the application dossier, and may request, with explanation of reason, the applicant to provide supplemental information and drug sample if necessary. After the examination, if the related provisions are met, CDE shall notify the applicant to file application for on site inspection of production site, and notify the Centre for Certification Administration (CCA) of SFDA.After the examination, if the related provisions are not met, CDE shall submit the remendation and application dossier to SFDA. SFDA shall make decision not to approve based on the technical examination remendation, and Notification of Review Opinion will be issued with explanation.Article 61: Upon receipt of the notification of on site inspection of production site, applicant should file at CCA application for on site inspection of production site within 6 months.. Article 62: Upon receipt of the application of on site inspection of production site, CCA shall within 30 days organize on site inspection of the production process of the sample, confirm the feasibility of the verified production process, take sample of 1 batch of product (3 batch for biological product), submit them for inspection to the drug control institute where the drug standards was verified, submit the inspection report of production site to CDE within 10 days upon pletion of the on site inspection.Article 63: The sample product shall be manufactured in a workshop with the GMP Certificate. For a newly established drug manufacturing enterprise or workshop or for the manufacture of additional drug dosage forms, the process of production of the sample product should ply with requirement of GMP.Article 64: The Drug Control Institute shall test the sample product in accordance with the verified drug standards, and submit the drug test report to CDE within the prescribed time, and send copies to the related PDA and the applicant.Article 65: CDE shall conclude a general examination remendation based on the technical examination remendation, inspection report of production site of the sample and sample test report, and then submit to SF