Main Article Content
Abstract
Background: The pharmaceutical sector operates within a dynamic and complex legal framework that governs drug development, approval, manufacturing, intellectual property, pharmacovigilance, and market authorization. Rapid advancements in biotechnology, digital health, and personalized medicine have necessitated significant legislative reforms globally. Objectives: This review comprehensively examines recent (2018–2024) advancements in pharmaceutical law across drug regulatory affairs, intellectual property rights, product liability, pharmacovigilance, digital health regulation, compulsory licensing, and emerging global harmonization efforts. Methods: A systematic narrative review was conducted using PubMed, Scopus, LexisNexis, and regulatory agency databases. Peer-reviewed literature, legislative texts, and official regulatory guidance documents published between 2018 and 2024 were included. Results: Key advancements identified include the US FDCA amendments (2022), EU Regulation 2022/123, ICH E6 (R3) revisions, FDA's Digital Health Center of Excellence guidelines, TRIPS Agreement flexibilities during the COVID-19 pandemic, expansion of the Biologics Price Competition and Innovation Act (BPCIA) framework, and enhanced post-market surveillance mandates. Conclusion: Pharmaceutical law is evolving rapidly in response to technological innovation, global health emergencies, and equitable access imperatives. Stakeholders must proactively engage with emerging legal developments to ensure compliance and foster innovation.