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; India-map-colourapprovals 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

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