Schedules: Clinical Trials

Last Updated on June 15, 2021 by The Health Master

Schedules: Clinical Trials

Schedules – New Drugs and Clinical Trials Rules 2019

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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 ScheduleClinical Trial – General principles and practices for Clinical Trial

Second Schedule – Clinical Trial Requirements and guidelines for permission to import or manufacture of New Drug for sale or to undertake clinical trial

Third Schedule Clinical Trial –Conduct of Clinical Trial

Fourth Schedule – Clinical Trial – Requirements and guidelines for conduct of bioavailability and bioequivalence study of New drug or investigational new drug

Fifth Schedule – Clinical Trial – Post market assessment

Sixth Schedule – Clinical Trial – Fee payable for licence, permission and registration certificate

Seventh Schedule – Clinical Trial – Formulae to determine the quantum of compensation in the cases of Clinical Trial related injury or death

Eight Schedule – Clinical Trial – Application Forms

Schedules: Drugs

Schedules: Cosmetics

Schedules: Medical Devices

Notifications: New Drugs, FDC, Clinical Trial

Other details about New Drugs, FDCs, Clinical trial

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