Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on March 21, 2023 by The Health Master
Schedules –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 all the Schedules introduced in these rules, Click below links for more information:
First Schedule – Clinical Trial – General principles and practices for Clinical Trial
First-Schedule-Clinical-Trials
Second Schedule – Clinical Trial – Requirements and guidelines for permission to import or manufacture of New Drug for sale or to undertake clinical trial
Second-Schedule-Clinical-Trials
Third Schedule – Clinical Trial –Conduct of Clinical Trial
Third-Schedule-Clinical-Trials
Fourth Schedule – Clinical Trial – Requirements and guidelines for conduct of bioavailability and bioequivalence study of New drug or investigational new drug
Fourth-Schedule-Clinical-Trials
Fifth Schedule – Clinical Trial – Post market assessment
Fifth-Schedule-Clinical-Trials
Sixth Schedule – Clinical Trial – Fee payable for licence, permission and registration certificate
Sixth-Schedule-Clinical-Trials
Seventh Schedule – Clinical Trial – Formulae to determine the quantum of compensation in the cases of Clinical Trial related injury or death
Seventh-Schedule-Clinical-Trials
Eight Schedule – Clinical Trial – Application Forms
Eighth-Schedule-Clinical-Trials
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Notifications: New Drugs, FDC, Clinical Trial
Other details about New Drugs, FDCs, Clinical trial
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