As per ICH-GCP E6 Guidelines, Approval in clinical trials is defined as “The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.”

A drug, device or biologic must be approved by a country’s regulatory agency before it can be marketed. The approval process involves several steps, including pre-clinical (animal) studies, clinical trials for safety and efficacy, filing of a New Drug Application (NDA) in the United States or Marketing Authorization Application (MAA) in Europe by the manufacturer, regulatory agency review of the application, and agency approval/rejection of application.

An approved drug is a preparation that has been validated for a therapeutic use by a ruling authority of a government.

In the United States, the FDA approves drugs. Before a drug can be prescribed, it must undergo the FDA’s approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then tested for safety and effectiveness in humans (clinical trials). The drug manufacturer then files a New Drug Application to the FDA, which reviews the application and either approves or rejects it.

In the European Union, it is the European Medicines Agency (EMA) that evaluates medicinal products.

Approval Process by FDA

You can see below image for the complete Drugs Approval process by the Food and Drugs Administration (United States). You can see the FDA drug development and Approval Process with an example here.

FDA_drug_approval_process

FDA approved the first drug based on salmon calcitonin in an injectable. Since then, two more drugs, one injectable and one administered through a nasal spray were approved.  An oral version of salmon calcitonin is in clinical trials now.  Salmon calcitonin is approved only for postmenopausal women who cannot tolerate estrogen, or for whom estrogen is not an option.