Last Updated on March 21, 2023 by The Health Master
Schedules: Clinical Trials
Schedules – 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
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: All types of Cosmetics
Schedules: All types of Medical Devices
Schedules: All types of Clinical Trials
Notifications: New Drugs, FDC, Clinical Trial
Other details about New Drugs, FDCs, Clinical trial
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