Articles -Pharma & Cosmetics

Forms: All types of Clinical Trials

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

Rakesh Dahiya

June 21, 2021

10541

Forms for Allopathic drugs Medical Devices Homoeopathy Cosmetics Clinical trial — Forms

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Rakesh Dahiya

SDCO Cum Licensing Authority |
Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com

Forms of all types of Clinical Trials under 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:

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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 Dahiya, SDCO cum Licensing Authority, FDA Haryana

Also read

Forms: Drugs

Forms: Cosmetics

Forms: Medical Devices

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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)