Understanding The General Approval Process Of Generic Medicines

Understanding The General Approval Process Of Generic Medicines
3 min read
24 November 2022

Understanding The General Approval Process Of Generic Medicines

Generic medicines are the most righteous solution to the rising medicinal unaffordability in the world. Being highly standard yet affordable is what makes generic medicines stand out.

However, how and why should one trust these affordable medicines? Is the quality compromised due to a lesser profit margin? And such other doubts are the ones that need to be clarified.

To cut short, generic medicines undergo an arduous screening process to gain approval for commercial utility.

The organization that sanctions these approvals is called the Food and Drug Administration (FDA), the federal agency of the Department of Health and Human Services (United States Jurisdiction).

In this article, we will check out the step-by-step process of this approval process so that the next time you visit a chemist shop, you ask for generic medicines.

  • The generic medicines manufacturer’s challenge is to prove to the FDA that its product is substitutable with a brand-name medicine that has been proven safe and effective.
  • Whereas FDA requires the generic medicine company to produce enough data to demonstrate that the company can make a medicine that can be appropriately substituted for the brand-name product.
  • The data includes the manufacturing process and answers some vital questions like how the generic medicines will be made by combining the active ingredient, which actually provides the treatment, and the inactive ingredients.
  • Once the data is submitted, FDA’s health care professionals and scientists with a wide range of expertise work together to analyze this data.
  • High-end scrutiny is implemented to ensure the safety of generic medicines. The medicines are effective, high-quality, and substitutable for the brand-name drug.
  • The FDA thoroughly examines the submitted data and evaluates the information the investigators obtain while inspecting the related testing and manufacturing facilities.
  • After completing this entire procedure, the generic medicines are finally approved.
  • However, the process doesn’t end here, as the generic manufacturers need to report any problems and serious adverse health effects to FDA for further evaluation.
  • The FDA periodically inspects and proposes changes to the manufacturing plants and continues monitoring medicine quality.
  • After these evaluations are over, the generic medicine gets its approval status.

Take Away

Brand-name medicines are already complete with the demonstration of the safety and effectiveness of their medicines with expensive and time-consuming research and development programs, including clinical studies.

They also make immense efforts to familiarise their product to the masses until it gets popular.

However, generic medicines do not have to repeat these studies, hence are cheaper yet equally high-quality than brand-name medicines.

The only thing generic medicines need to go through is the critical approval process to re-manufacture the brand-named medicines under the generic label.

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