The Pharma Legal Handbook: Vietnam

Vietnam is one of Southeast Asia's fastest-growing pharmaceutical markets, with a rapidly expanding middle class, increasing healthcare spending, and a regulatory framework that has been subject to significant modernisation under the updated Law on Pharmacy. The Drug Administration of Vietnam (DAV) manages product registration and post-market surveillance.

Vietnam's health insurance system, administered by the Vietnam Social Security agency, covers a significant proportion of the population and the insured drug list is an important channel for reimbursable products. Vietnam has been strengthening its GMP requirements and aligning with WHO and ASEAN standards.

The Pharma Legal Handbook: Vietnam provides comprehensive guidance on pharmaceutical regulation in Vietnam, covering DAV product registration, pricing and reimbursement frameworks, clinical trial requirements, pharmacovigilance obligations, manufacturing and GMP requirements, marketing rules, and intellectual property protection.