Schedules: All types of Clinical Trials

Schedules –All types of Clinical Trials under New Drugs and Clinical Trials Rules 2019

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Last Updated on June 18, 2021 by The Health Master

Schedules –All types of Clinical Trials under New Drugs and Clinical Trials Rules 2019

Rules Law
Picture: Pixabay

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 DahiyaSDCO cum Licensing Authority, FDA Haryana

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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