Forms: All types of Clinical Trials

Applications Forms of all types of Clinical Trials under New Drugs and Clinical Trials Rules 2019

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Regulation Law Act
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Last Updated on January 22, 2023 by The Health Master

Forms of all types of Clinical Trials under 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-1

Form CT-2: Grant of registration of ethics committee relating to clinical trial or bioavailability and bioequivalence study
Form-CT-2

Form CT-3: Grant of registration of ethics committee relating to biomedical health research
Form-CT-3

Form CT-4: Application for grant of permission to conduct clinical trial of new drug or investigational new drug
Form-CT-4

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-4A

Form CT-5: Application for grant of permission to conduct bioavailability or bioequivalence study
Form-CT-5

Form CT-6: Permission to conduct clinical trial of new drug or investigational new drug
Form-CT-6

Form CT-7: Permission to conduct bioavailability or bioequivalence study of new drug or investigational new drug
Form-CT-7

Form CT-8: Application for registration / renewal of bioavailability or bioequivalence study centre
Form-CT-8

Form CT-9: Grant of registration of bioavailability or bioequivalence study centre
Form-CT-9

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-10

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-11

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-12

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-13

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-14

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-15

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-16

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-17

Form CT-18: Application for grant of permission to import new drug for sale or for distribution
Form-CT-18

Form CT-19: Permission to import new active pharmaceutical ingredient for sale or for distribution
Form-CT-19

Form CT-20: Permission to import pharmaceutical formulations of new drug for sale or for distribution
Form-CT-20

Form CT-21: Application for grant of permission to manufacture new drug formulation for sale or for distribution
Form-CT-21

Form CT-22: Permission to manufacture new active pharmaceutical ingredient for sale or for distribution
Form-CT-22

Form CT-23: Permission to manufacture pharmaceutical formulation of new drug for sale or for distribution
Form-CT-23

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-24

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-25

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-26

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
Form-CT-27


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana

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