NeuAge Institute (NAI)

An Introduction to the Generic Drug Submission Process for Students in Regulatory Affairs Training

A trio of generic medication examples alongside their respective packaging as emphasized in regulatory affairs training.

Generic drugs are versions of brand-name medications developed by different companies. They are usually more affordable, which is great news for the public. However, like any other scientific and regulatory process, obtaining approval for a generic drug is a complex process. The FDA needs time to carefully review all the complex data to ensure the generic drug can be safely and effectively substituted for the original brand-name drug. How long this takes depends on the complexity of the drug and how comprehensive the application is.

If you’re a student undergoing regulatory affairs training, this blog post aims to provide a concise introduction to the complex world of generic drug submissions.

A Closer Look at Generic Drugs

As you’ll discover in regulatory affairs training, a generic drug has the same active ingredients in the exact quantities. It is presented in a similar form as its brand-name counterpart. It. While a generic medication might contain different inactive ingredients compared to its brand-name counterpart, the manufacturing company must demonstrate that these variations don’t compromise the drug’s safety, effectiveness, or quality. It’s common to find multiple generic versions of a single brand-name drug. These generics are typically more budget-friendly.

When submitting a generic drug application to the FDA for approval, it is imperative to demonstrate that: 

  • The generic drug is “pharmaceutically equivalent” to the brand
  • The manufacturer is capable of making the drug correctly and consistently
  • The “active ingredient” is the same as the brand
  • The right amount of the active ingredient reaches its target area
  • The “inactive” ingredients of the drug are safe
  • The drug does not break down over time
A combination of generic drugs analyzed by a professional after regulatory affairs training.
As per our regulatory affairs training, a generic drug application needs to fulfill the requirements.

The submission process for generic drugs can broadly be broken down into the following steps:

Regulatory Affairs Training Covers Pre-submission Activities

Before submission, companies invest heavily in R&D to develop a generic version bioequivalent to the brand-name drug. This means the generic drug will work similarly and provide the same clinical benefit as its branded counterpart.

A generic patient information form, which you'll dissect and familiarize yourself with during regulatory affairs training
As regulatory affairs training highlights, generic drugs must undergo bioequivalence studies.

Once the generic version is ready, the next step is to prepare a comprehensive report that contains all the scientific data proving that the generic drug is bioequivalent to the reference product. This often involves bioequivalence studies and clinical trials comparing the generic drug to the branded one.

Submission to Health Authorities and Review by Health Authorities

With the dossier ready, the next step is the submission to the health authority (like the FDA in the U.S.). Here, regulatory affairs professionals present the generic drug’s data, proving its safety, quality, and efficacy. The data must illustrate the production method – detailing how the generic drug will be produced by merging the active and inactive ingredients. This information, as our regulatory affairs courses emphasize, helps regulatory agencies determine if the manufacturer can consistently produce a top-quality product.

Once the submission is received, the health authority will review the generic drug’s dossier. This review process ensures that the drug is safe for consumption, effective, and high-quality. Any discrepancies or concerns will be relayed back to the company for rectification. The FDA also examines the labeling and packaging of prospective new drugs to make sure the information provided is both accurate and precise for healthcare professionals and everyday consumers.

Approval and Market Launch

Next, an FDA team will conduct an on-site visit to the location where the drug is to be produced to review the manufacturing facilities. Upon satisfying all requirements and addressing any concerns raised by the health authority, the generic drug gets the green light for commercial sale. From here, the company can use marketing strategies to introduce its product to patients.

Are you interested in our regulatory affairs certificate program?

Contact the NeuAge Institute for more information.




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