Abstract

Platform technologies can be crucial in transforming the development of advanced drugs and biologics by optimising manufacturing processes while improving efficiency and quality. The US Food and Drug Administration’s (FDA) draft guidance ‘Platform Technology Designation Program for Drug Development’, issued in May 2024, explains that platform technologies must be well-understood and reproducible, details the expectations and outlines the submission process to obtain such designation. This designation allows drug manufacturers to leverage established technologies across multiple products, streamlining the drug development process, regulatory review and approval. It potentially reduces development time and costs through more strategic, collaborative interactions with regulatory authorities. While this designation can be a game-changer for companies in expediting drug development, it also comes with challenges, including meeting the stringent eligibility criteria and ensuring that the applicability of the precedent product’s data to subsequent products incorporates the same technology.

This article discusses the platform technology designation (PTD) initiative, including its key elements, challenges and its significance in the regulatory landscape. It also explores the activities and strategies for sponsors at various stages, from pre-approval preparation to post-approval management.