Forms: Clinical Trial

Last Updated on June 20, 2021 by The Health Master

Forms: Clinical Trial

Applications Forms: New Drugs and Clinical Trials Rules 2019

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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 DahiyaSDCO cum Licensing Authority, FDA Haryana

Forms: Drugs

Forms: Cosmetics

Forms: Medical Devices

Notifications: New Drugs, FDC, Clinical Trial

Other details about New Drugs, FDCs, Clinical trial

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