Forms: Clinical Trial

Last Updated on November 27, 2024 by The Health Master

Forms: Clinical Trial

Applications Forms: New Drugs and Clinical Trials Rules 2019

Law
Picture: Pixabay

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

Schedules: Drugs

Schedules: Cosmetics

Schedules: Medical Devices

Schedules: Clinical Trials

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

Procedure to obtain license for Medical Store / Pharmacy

How to start Jan Aushadhi Store: Procedure

Licenses-fee-structure-for-all-licenses

Notifications: New Drugs, FDC, Clinical Trial

Other details about New Drugs, FDCs, Clinical trial

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news