In order to be able to respond to requests for early access of a drug in a timely manner, companies should plan to implement a comprehensive strategy at a global level.

The type and scope of the global access program (GAP) that is run will depend on considerations such as demand, regulatory feasibility, the license status of the product, and necessary drug pricing structure, as well as company strategy, costs, and product supply.

Successful GAPs require careful and efficient planning and management, from set-up to closure, by either an internal coordinating project manager or a specialist provider.

Throughout the article, we use the term ‘GAP’. These are often referred to as early access programs, but we use this as an umbrella term that covers multiple scenarios including, but not limited to, where the medicinal product may be completely unlicensed globally but also where it may be approved in a major market but is not yet approved in the country of required supply.