Article 154th in any of the following circumstances, the State Food and drug administration shall not grant approval:
(a) different applicants submit research data, data with the sameor similar, and without justifiable reasons;
(two) found that the reporting of information not true in the registration process, the applicant is unable to prove that itreturns true;
(three) to evaluate the safety, effectiveness, quality control is notthe design and implementation of research projects to support itsapplication for drug;
(four) the declaration data shows that its application has some defects of drug safety, effectiveness, quality control etc.;
(five) failed to supplement the materials within the prescribed time limit;
(six) API is not in conformity with the provisions;
(seven) the production on-site inspection and sample inspectionresults are not in accordance with the provisions of the;
(eight) other circumstances stipulated by laws and regulationsshall not be approved.
155th if a pharmaceutical supervisory and administrativedepartments to make a written decision shall not accept or approve the application in accordance with the law, it shall explain the reasons, and inform the applicant of the right to administrative reconsideration or bring an administrative lawsuit.
156th the applicant to make to the State Food and drug administration not to approve the decision has objections, can bein receipt of the notice not to grant the approval within 60 days from the date of completing "drug registration review application form", an application for review to the State Food and Drug Administration and explain the reasons.
Review of the content is limited to the original application andoriginal reporting data.
Article 157th the State Food and drug administration to review the application, shall make a decision within 50 days, and notify the applicant. Maintain the original decision, the State Food and drug administration no longer accepts the application for review again.
The 158th review of the need for a technical review, the State Food and drug administration shall organize the relevantprofessional and technical personnel in accordance with the original application time limit.