Abstract 

Regulatory authorisation and market access have historically operated as linked but separate domains, with regulatory review often preceding pricing, reimbursement or health technology assessment (HTA) decision-making across markets. The COVID-19 pandemic disrupted that model, compelling regulators, HTA bodies and payers to work within compressed timelines, accept iterative evidence submissions, activate emergency mechanisms and collaborate across jurisdictions. This article examines how those interfaces evolved across 11 key markets over three periods: the pre-COVID-19 era (2000-2019), the acceleration phase during COVID-19 (2020-2021/22), and the post-COVID-19 period of institutionalisation (2022–January 2026).

Drawing on an evidence-first policy review of primary regulatory, HTA, payer and legal sources, supported by peer-reviewed literature, the analysis identifies three areas of convergence: greater use of reliance and work-sharing pathways; more structured alignment between regulatory and HTA or payer processes; and more explicit lifecycle evidence expectations, including wider use of real-world evidence and post-authorisation evidence generation. Yet convergence remains incomplete. Persistent differences in payer centralisation, HTA maturity and pricing controls continue to shape access environments and unequal demands. Regulatory affairs is no longer an approval-enabling function, but a strategic integrator of regulation, evidence and access, with competitive value increasingly determined by how early and how well companies align regulatory strategy with access realities.