Data and information required for grant of permission to conduct bio availability and bioequivalence study of a new drug or investigational new drug
Document required for registration of bio availability and bioequivalence centre
Data elements for reporting serious adverse events occurring in a clinical trial or bio availability or bioequivalence study
Import of New drug/Investigational drug for clinical trials
Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or Any person or institution or organisation who intends to import a new drug or any substance relating thereto for conducting clinical trial or The application under sub-rule (2) shall be accompanied by […]
Registration of Bioavailability and Bioequivalence study centre
Application for registration of bioavailability and bioequivalence study centre Application for registration of any bioavailability and bioequivalence study centre with the Central Licencing Authority shall be made to the said authority in Form CT-08. The application under sub-rule (1) shall be accompanied by a fee as specified in the Sixth Schedule and such other information […]
Application for conducting Bioavailability or Bioequivalence study
Any person or institution or organisation which intends to conduct bioavailability or bioequivalence study of a new drug or an investigational new drug in human subjects shall obtain permission for conducting bioavailability or bioequivalence study from the Central Licencing Authority by making an application in Form CT-05. The Central Licencing Authority may, after scrutiny of […]
