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Generic Drug Approval Process

Generic drug manufacturer must gain FDA approval for selling drug in USA, though they do not need to repeat the clinical trials of the reference listed drug (RLD) they copy.The application for generic drugs approval in USA is the Abbreviated New Drug Application (ANDA). It’s called “abbreviated” because the manufacturers don’t need to include animal and human data to establish safety and effectiveness.

But the generic drug manufacturers must prove that the ingredient in the drug that is effective against the illness or condition it’s treating is the same as that of the reference listed drug. The manufactures also need to show that the generic drug is bioequivalent to reference listed drug.

FDA Generic Drug Approval time

It depends on the complexity of the drug product and the completeness of the application.The goal for standard review is to get a drug through the approval process in 10 months. But some generic versions of priority drugs that offer major advances in treatments or that provide treatment where none existed. The FDA aims to get a drug through the entire process in six months or less.

Data Required for Generic Drug Approval by FDA

There are several types of data generic companies must submit to USFDA for review and evaluation. For example -how the generic drug is made by combining the active ingredient and the inactive ingredients, generic drug is behave the same way in patients as its RLD counterpart (to prove this, the company is often required to conduct trials with human volunteers who take both the brand and generic drug products) and also need to show that the drug will not deteriorate over time.

Reasons for Delayed or Denied

Unexpected safety issues, manufacturing issues or a failure to prove a drug’s effectiveness are reasons for FDA may deny a new drug application. When FDA denies a drug approval, they outline its reasoning in a response letter to the pharmaceutical company who submitted the application.The agency also provides the drug company with the opportunity to meet with FDA officials to discuss the issues. The company can then ask for hearing, correct any issues and submit new information, or withdraw the application.

Once a generic drug is approved, manufacturers must report any problems and serious adverse health effects to FDA for evaluation. They will periodically inspect manufacturing plants and continue to monitor the drug quality. And they also evaluate any proposed changes to the generic drug product after it is approved.

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