Abstract

The combined advent of generative artificial intelligence (GenAI) and Health Level 7’s (HL7) next generation standard for Fast Healthcare Interoperability Resources (FHIR) has lifted a rarely discussed ‘chilling effect’ on regulatory innovation. The regulatory ecosystem and its resource capacity has been modernised, resulting in revolutionary shifts in how regulatory affairs will operate in the pharmaceutical industry.  

This article describes the business impact of lifting this chilling effect and how pharmaceutical organisations can leverage this new paradigm to maximum effect and impact. This includes accelerating document generation timelines, replacing the staggered submission wave model with a simultaneous global submission model, and delivering personalised label content to patients on demand. 

The scale and pace of this change will be significant. Industry and regulators will need to collaborate and coordinate change management and upskilling efforts to maximise the benefits and incentives, and ensure there is a smooth transition as our industry moves into a more modern way of creating, receiving and processing information.