The European Federation of Pharmaceutical Industries and Associations (EFPIA) advocates for the modernization of marketing authorization (MA) renewal requirements worldwide. While many countries continue to require periodic renewals—typically every five years—other jurisdictions have moved to permanent authorizations, one-time renewals, or administrative auto-renewal systems.

EFPIA argues that recurring dossier-based renewals have become largely redundant because modern regulatory systems already provide continuous oversight through pharmacovigilance, GMP inspections, post-approval change management, and other lifecycle controls. These mechanisms continuously monitor the safety, efficacy, and quality of medicines and allow regulators to suspend or revoke authorizations when necessary.

To address the issues, EFPIA recommends a risk-based approach to MA maintenance. The preferred long-term objective is the adoption of permanent marketing authorizations or simplified administrative renewals in jurisdictions with mature post-marketing surveillance systems.