LEGAL RESPONSIBILITIES OF PHARMACEUTICAL MANUFACTURERS IN VIETNAM: A COMPARATIVE STUDY OF INTERNATIONAL PRACTICES

Resumen

This article provides a comprehensive analysis of Vietnam’s legal framework governing the responsibilities of pharmaceutical manufacturing establishments, including those producing medicinal ingredients. It examines both the statutory provisions and the practical implementation of these regulations by enterprises operating within the sector. Through this dual lens, the study identifies key strengths in regulatory design, persistent challenges in enforcement, and systemic gaps that hinder compliance and operational efficiency. The research highlights the evolving nature of Vietnam’s pharmaceutical legislation, particularly in light of recent amendments aimed at aligning domestic standards with international best practices. It also explores the implications of these legal developments for both domestic and foreign-invested enterprises, considering the broader context of Vietnam’s ambition to become a regional hub for pharmaceutical innovation and production. Drawing on comparative insights from countries with mature pharmaceutical industries such as the United States, Japan, India, and member states of the European Union, the article proposes targeted legal and policy reforms. These recommendations are intended to enhance regulatory clarity, support sustainable industry growth, and foster a more competitive and transparent pharmaceutical ecosystem in Vietnam.