The India profile in ClinRegs now includes three circulars issued on November 10, 2015. The circulars address the clinical trial application process for academic research; approvals for adding trial sites and investigators; and approvals for investigational products.
Changes have been made to the following topics and subtopics:
- Competent Authority Oversight: Scope of Assessment
- Ethics Committee Oversight: Scope of Review
- Clinical Trial Lifecycle: Submission Process, Commencement of Trial
- Sponsorship: Trial Authorization, Commencement of a Trial, Investigational Medicinal Products/Investigational New Drugs
- Investigational Products: Manufacturing Authorization, The Information and Data Required to Support the Quality of the IMP/IND