Innovative industry perspective: Assessing the proposed regulatory changes and their impact on innovation and competitiveness of the EU regulatory framework as part of the EU General Pharmaceutical Legislation revision

Abstract

This study is the innovative pharmaceutical industry's assessment on the European Union (EU) General Pharmaceutical Legislation and proposed legislative revisions analysed across seven domains: robustness, patient centricity, predictability, speed, agility, efficiency, and innovator support. Based on interviews, workshops, and literature reviews, the current system is robust, predictable, and patient-centred but lacks agility, efficiency, and speed. The analysed changes included the Regulatory Sandbox, scientific support for combination products, diversification of evidence, and marketing authorisation holder (MAH) involvement in labelling decisions. A Regulatory Sandbox enhances the agility, speed, and innovation of the system. Three concerns weaken the effectiveness of the system: the complexity of providing scientific support for combination products, a lack of flexibility in utilising diverse types of evidence, and the exclusion of MAHs from labelling decisions. Policymakers must address these gaps to achieve a competitive legal framework.