Most countries highly regulate pharmaceuticals because they concern human health and life. Vietnam is not an exception. The regulatory environment is complicated further by Vietnamese laws that prohibit foreign participation in the distribution of drugs. There are also strict prohibitions and guidelines on the marketing of medicines and onerous requirements for the employment of medical representatives. These factors combine to make a highly challenging regulatory environment.

Our pharmaceutical regulatory team can provide clear and practical guidance in this area. In particular, our Michael Lee acted as the primary local counsel to global innovative pharmaceutical giant  Merck Sharp & Dohme during his eight years as a partner at Tilleke and Gibbins. He also advised Besins, Servier, and Ipsen there. At Dilinh, Michael continues to advise Besins, Ipsen, and Mayoly. He has provided regulatory advice to prominent drug companies in Vietnam since 2010.