GCP: A Question & Answer Reference Guide * A re-submitted CTA/NDA application by an applicant who has withdrawn the CTA application previously submitted or being reviewed for a generic drug according to the new regulatory criteria that require both bioequivalent and quality conformance to the corresponding parent drugs; In the campaign of "reevaluation of generic drug bioequivalent and quality conformance", a supplementary NDA application with changes of approved manufacturing process. * Registration for an imported new drug to transfer the manufacturing line to the domestic. Any applicant who wishes to apply for the FTRP should be spontaneously submitting the application form with the experts' recommendations together with CTA/NDA package. Once the CDE CFDA approves the application, the approval notice will be published at the web of the CDE CTA/NDA review process domain. The official FTRP is initiated in the 5 working days without any public dissents. Any public dissent should be submitted with the dissent form in writing to the CDE within 5 working days post the web notice, followed by argumentation by a designated advisory panel within 10 working days. The final decision will be informed to both applicant and dissenting party. The following diagrams present the general FTRP: For a CTA application: For an application of Product Manufacturing License for NDA (after the phase III completion) and generic drug: 604