Vietnam’s Ministry of Health has issued a new circular, taking effect on October 1, 2026, aimed at streamlining drug registration. The update is designed to cut down on paperwork and procedural delays that have long been a pain point for foreign companies registering drugs in Vietnam.
First of all, new drugs backed by first-time clinical trial submissions will receive five years of data protection from their initial marketing authorization, during which competing applicants cannot rely on that data for their own approvals. The circular also loosens documentation requirements for foreign applicants by allowing electronic notarized copies in place of hard-copy paperwork and letting authorities verify foreign legal documents through digital channels rather than requiring formal consular legalization.
The circular also addresses several other technical requirements. It sets more detailed rules for submitting electronic certificates of suitability to European Pharmacopoeia monographs (CEPs), which manufacturers use to show their ingredients meet EU quality standards. Applicants for new drugs also get more flexibility on timing: they can delay submitting a Certificate of Pharmaceutical Product up until their second round of dossier supplementation. When a finished drug uses an ingredient already approved in Vietnam, manufacturers no longer need to submit separate paperwork proving that ingredient’s factory meets GMP (Good Manufacturing Practice) standards.
In addition, applicants denied a registration, renewal, or variation will have one month to submit a written rebuttal, and if accepted, can avoid restarting the process with an entirely new dossier.