Last Updated on January 24, 2023
The application for registration of clinical trials, clinical trial sites, Contract Research Organizations (CRO) and Bioequivalence/ Bioavailability (BE/BA) studies centers are reviewed by the Division of Pharmacy Service, DRAP. Application evaluation summaries are presented before the Clinical Study Committee (CSC) of DRAP. The Evaluation process flows for registration and license of clinical trials are provided below:
Authorization to Conduct Clinical Trials :-
Application for authorization to conduct clinical trail shall be submitted by the applicant on Form II with supporting documents (as per checklist) and applicable fee. The evaluation process flow is being provided for illustrative purpose.
Registration to Conduct Bio-availability and Bio-equivalence Studies:-
Application for registration to conduct Bioavailability/Bioequivalence study shall be submitted on Form II-A with supporting documents (as per checklist) and applicable fee. The evaluation process flow is being provided for illustrative purpose.
Grant of License for Contract Research Organization (CRO), Clinical Trial Site (CTS), BE/BA Studies Center or Bio-analytical Laboratory:-
Application for grant of License for Bioavailability/Bioequivalence studies center, Clinical trial site, Contract Research Organization (CRO) or Bioanalytical laboratory shall be submitted on Form-I by the applicant along with requisite documents (as per checklist) and applicable fee. The evaluation process flow is provided for illustrative purpose.
Grant of Renewal of License for Contract Research Organization (CRO), Clinical Trial Site (CTS), BE/BA Studies Center or Bio-analytical Laboratory:-
Application for grant of renewal of License for Bioavailability/Bioequivalence studies center, Clinical trial site, Contract Research Organization (CRO) or Bioanalytical laboratory shall be submitted on Form-III with supporting documents and applicable fee. The evaluation process flow is provided for illustration.