How generic drug names are decided

Who is in charge?

There are two main organizations are responsible for assigning generic drug names:

The United States Adopted Names (USAN) Council: A collaborative effort between the U.S. Food and Drug Administration (FDA) and the American Medical Association (AMA).

World Health Organization (WHO) International Nonproprietary Names (INN) Programme: Sets guidelines for generic drug names globally.

The USAN Council and WHO INN Programme collaborate to ensure new generic names are:

non-proprietary, ie not owned by any one company, avoiding confusion with brand names; informative, ideally, the name should reflect the drug’s therapeutic class or mechanism of action in a clear and concise way; internationally Unique,  the name should be easy to pronounce and avoid offensive meanings across different languages and cultures.

What is the naming process?

  1. Proposal Stage:

Pharmaceutical companies or researchers submit proposals for new generic drug names to the USAN Council. Proposals include information about the drug’s chemical structure, pharmacological activity, and intended use.

  • Evaluation and Selection:

The USAN Council evaluates proposals based on the established criteria (non-proprietary, informative, unique). They consider potential for mispronunciation, similarities to existing drugs, and cultural sensitivities.

  • Public Notice and Feedback:

The proposed generic name is published for public review and comment. This allows identification of any issues before finalization.

  • Collaboration with WHO:

The USAN Council works with the WHO INN Programme to harmonize the generic name globally. The goal is to ensure a single generic name is used internationally.

  • Finalization and Publication:

Once approved, the generic name is published in official drug reference lists.

By following a collaborative and well-defined process, these international organizations  work  to  create  clear, informative, and globally  usable  generic drug names  for the benefit of patients and healthcare professionals worldwide. Generally, the naming process can take several months to ensure thorough evaluation and avoid future problems.