The Global Drug Development Process Map

A comprehensive interactive tool for guiding developers, grantees, or anyone involved in the process of developing therapeutic drugs and administration devices.

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About the Process Map

This interactive process map takes you through the various stages and phases of product development, including:

  • Therapeutic drug development

    A comprehensive overview of the step-by-step process of discovery and development of biologics.

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  • Administration device development

    Products which require "combination product" development considerations.

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  • Advanced drug delivery system development

    Products which share product development considerations of combination products, but are not necessarily held under the same regulatory agency requirements.

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This website was created in collaboration by the Bill & Melinda Gates Foundation and the Global Health Network

Please note that some of the information in this map is specific to the practices of the Bill & Melinda Gates Foundation. Examples of this include Partner Management and Global Access. Additionally, some terminology used in this map reflects the specific terminology used at the Bill & Melinda Gates Foundation, however the activities are common practices. An example of this would be the term ‘Stage Gate’, which is a go/no-go decision point in the development lifecycle.

We will continue to develop this product, and welcome any feedback you wish to provide.

For questions regarding the content development process please contact Stephen Gerrard: stephen.gerrard@gatesfoundation.org.