Experts from Tilleke & Gibbins have written The Pharma Legal Handbook: Vietnam, published by Pharma Boardroom, a comprehensive guide to the legal framework regulating the pharmaceutical sector and related industries in Vietnam [Latest update: September 2022]. Authored by the Hanoi-based team of Hien Thi Thu Vu, head of regulatory affairs for Vietnam, and Mai Thi Le, regulatory affairs consultant, the handbook is a must-read for healthcare and life sciences companies that are interested in the Vietnam market.
The guide includes eight sections on various important aspects of local regulations:
- Regulatory, Pricing, and Reimbursement Overview
- Preclinical & Clinical Trial Requirements
- Marketing, Manufacturing, Packaging & Labeling, and Advertising
- Traditional Medicines and Over-the-Counter Products
- Product Liability
- Patents and Trademarks
- Regulatory Reforms
- Orphan Drugs and Rare Diseases
The first section of the handbook—Regulatory, Pricing, and Reimbursement Overview—is provided via the link below, and the complete guide is available for purchase on the Pharma Boardroom website.