Pharmaceutical/Drug Registration in Vietnam

Vietnam's pharmaceutical/drug market is about $1 billion. Vietnam's pharmaceutical regulators are the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV). All pharmaceuticals require both product approval and a separate import permit. In an attempt to improve the overall pharmaceutical market in Vietnam, the country's National Assembly approved a new Pharmceutical Law in May 2005.

The MOH reviews all pharmaceutical/drug applications and if they are approved, they will issue the approval license. In April 2004, the MOH established a drug review panel to review applications for the approval of drugs not yet registered for distribution in Vietnam. Some product approval processes will also include product sample analysis, though this occurs only in about ten percent of all application processes.

The Vietnamese government is very concerned about keeping rising drug prices in check, and pharmaceutical import licenses must disclose the product's price. Local expertise can help avoid or limit government price restrictions.

For more information on pharmaceutical/drug registration in Vietnam, please see the following PBM publications and/or contact us to discuss your specific needs.