How to Register a Generic Medicine

A generic medicine is a medicine that is marketed without a trade (brand) name. When the drug's patent has expired, the same company may market the drug under its trade or generic name, while other companies who file to market the drug must use the same generic name but may use their own trade name. Consequently, many generic versions of the drug may be on the market under a single generic name and different trade names. Because generic drugs require less extensive development, they are generally less expensive than innovator drugs.

A registered generic drug is a generic drug with marketing authorization. The regulatory authority in the United States is the U.S. Drug and Food Administration (FDA). Generic applicants make an Abbreviated New Drug Application (ANDA) which is reviewed by FDA's Office of Generic Drugs (OGD). OGD highly recommends that submissions be made in an electronic Common Technical Document (eCTD).

Things You'll Need

• eCTD sample application for an Abbreviated New Drug
• eCTD application for an Abbreviated New Drug
• eCTD software
• Professional consulting services for eCTDs/FDA regulatory processes

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Instructions

• 1

  Review FDA's eCTD guidances by visiting the FDA eCTD website.

• 2

  Consult the FDA guidances for ANDAs. Recent guidances are grouped together on the ANDA page, while the complete list of available guidances online and instructions on how to obtain them are available on the Drug Information Branch's Guidance Documents page.

• 3

  Contact the Office of Business Process Support (OBPS), Division of Regulatory Review Support at [e-mail] when you are ready to begin the application process. This initiates dialogue with the FDA about your future application and enables you to submit a sample eCTD.

• 4

  Prepare a sample eCTD. The sample eCTD is processed by the FDA to ensure that your official application is in proper technical shape for submission. The content of the sample application is not reviewed.

• 5

  Use software that can interface with document management systems for your eCTD sample and official applications. The FDA recommends conducting an Internet search for eCTD software that will allow you to build, validate and view eCTDs. Some companies that specialize in electronic regulatory submissions will offer both software and submissions consultation services.

• 6

  Correct any errors that are found in your sample eCTD in accordance with the FDA report and if necessary resubmit the revised eCTD sample application using the same sequence number. Once the corrections are complete, your application will be technically ready for submission.

• 7

  Submit your official eCTD for review. ANDAs are submitted to the Office of Generic Drugs, 7500 Standish Place, Rockville, MD, 20855.