Review of New Drug Applications

　　　CDE is responsible for the quality, safety and efficacy of NDA review under the teamwork of experts of CMC, Pharm/Tox, PK, Medical and Statistics.

　　　In general, CDE completes the NDA review within 100 calendar days and sends the assessment reports with recommendations to DOH. For cases of negative opinions due to major deficiencies of dossier, BPA will directly reject the application. However, most of the cases may need further discussion by the Advisory Committee（AC）which may encompass process AC for normal cases, process AC+ for cases with scientifically debatable issues, process AC++ for cases with social or public health issue.