Last Updated on December 14, 2024 by The Health Master
Forms: Clinical Trial
Applications Forms: New Drugs and Clinical Trials Rules 2019
As per New Drugs and Clinical Trials Rules 2019 we have provided Application Forms relevant to the above said topic, Click below links for more information:
Form CT-1: Application for registration / renewal of ethics committee relating to clinical trial or bioavailability and bioequivalence study or biomedical health research
Form CT-2: Grant of registration of ethics committee relating to clinical trial or bioavailability and bioequivalence study
Form CT-3: Grant of registration of ethics committee relating to biomedical health research
Form CT-4: Application for grant of permission to conduct clinical trial of new drug or investigational new drug
Form CT-4A: Information to initiate clinical trial of new drug or investigational new drug as part of discovery, research and manufacture in India
Form CT-5: Application for grant of permission to conduct bioavailability or bioequivalence study
Form CT-6: Permission to conduct clinical trial of new drug or investigational new drug
Form CT-7: Permission to conduct bioavailability or bioequivalence study of new drug or investigational new drug
Form CT-8: Application for registration / renewal of bioavailability or bioequivalence study centre
Form CT-9: Grant of registration of bioavailability or bioequivalence study centre
Form CT-10: Application for grant of permission to manufacture new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form CT-11: Permission to manufacture new drug or investigational new drug for clinical trial, bioavailability or bioequivalence study or for examination, test and analysis
Form CT-12: Application for grant of permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study
Form CT-13: Application for grant of permission to manufacture unapproved active pharmaceutical ingredient for development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study
Form CT-14: Permission to manufacture formulation of unapproved active pharmaceutical ingredient for test or analysis or clinical trial or bioavailability or bioequivalence study
Form CT-15: Permission to manufacture unapproved active pharmaceutical ingredient for the development of formulation for test or analysis or clinical trial or bioavailability or bioequivalence study
Form CT-16: Application for grant of licence to import new drug or investigational new drug for clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form CT-17: Licence to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis
Form CT-18: Application for grant of permission to import new drug for sale or for distribution
Form CT-19: Permission to import new active pharmaceutical ingredient for sale or for distribution
Form CT-20: Permission to import pharmaceutical formulations of new drug for sale or for distribution
Form CT-21: Application for grant of permission to manufacture new drug formulation for sale or for distribution
Form CT-22: Permission to manufacture new active pharmaceutical ingredient for sale or for distribution
Form CT-23: Permission to manufacture pharmaceutical formulation of new drug for sale or for distribution
Form CT-24: Application for licence to import of unapproved new drug for treatment of patients of life threatening disease in a government hospital or government medical institution
Form CT-25: Licence to import unapproved new drug for treatment of patients of life threatening disease in a government hospital or medical institution
Form CT-26: Application for grant of permission to manufacture unapproved new drug but under clinical trial for treatment of patients of life threatening disease in a government hospital or medical institution
Form CT-27: Permission to manufacture unapproved new drug but under clinical trial for treatment of patients of life threatening disease in a government hospital or medical institution
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Blood Centre (Blood Bank)
Procedure to obtain license for Commercial Testing Laboratories
Licenses fee structure for all licenses
Notifications: New Drugs, FDC, Clinical Trial
Other details about New Drugs, FDCs, Clinical trial
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