Publishing the registration status of products, country-by-country

Gilead publishes where it has filed for specific products to be registered, and when filings were successful.

Summary  

  • What: Gilead publishes on its website where it has filed for specific products to be registered, including whether and when filings were successful.
  • Objective: By providing this information, Gilead demonstrates accountability for its commitment to register new products in low- and middle-income countries within 12 months of market approval.
  • Details: The geographic reach of this activity is all low- and middle-income countries where Gilead has filed products for registration.
  • Product scope: This information is available for most of Gilead’s products for diseases in scope, including all its HIV/AIDS and hepatitis C products.

Looking closer

On its website, Gilead publishes where it has filed for specific products to be registered, including whether and when filings were successful. This information is available for most of its products for diseases in the scope of the Index, including all its HIV/AIDS and hepatitis C products.

It is the only company to publish registration status information in this level of detail: the industry standard in this area is to not publish such information. Public disclosure of the registration status of its products allows for external scrutiny of a company’s registration approach, and is valuable information to other stakeholders such as regulatory authorities and generic manufacturers.

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