Market Watch: Vietnam opens a reliance route for six regulators

What changed. Vietnam's Ministry of Health issued a new circular on drug registration that allows an abbreviated assessment for products already approved by one of six named authorities: the European Medicines Agency, the US FDA, the UK MHRA, Japan's PMDA, Health Canada and Swissmedic.¹

Circular 32/2026/TT-BYT was issued on 29 July 2026 and takes effect on 1 October 2026.

What it does. For a qualifying product, the assessment becomes a verification of technical consistency with the reference approval rather than a full technical re-review. Marketing authorisation validity extends to five years, with automatic continuation where a renewal is filed before expiry, and multiple pack sizes and manufacturing sites can sit under a single registration.¹

Why this is worth noticing. Vietnam has generally been assessed as a full-dossier market, which put it late in most Asian launch sequences behind Singapore, Malaysia and Australia. A reliance route changes where it belongs in the order, and reliance routes tend to be busiest in their first year, before queues form.

Note also what the list is and is not. It names six national and regional authorities. It does not name EU notified bodies, and it does not include the regional reliance arrangements now operating in Southeast Asia. A company whose strongest asset is a CE mark rather than a medicines approval from one of the six gets nothing from this.

What to do now. If you hold an approval from any of the six, assemble the reference evidence pack: the approval letter, the approved labelling and the assessment report. Then file after 1 October under the new route rather than the full dossier route, and re-check any Vietnamese registration approaching expiry against the automatic continuation provision.

If you do not hold one of the six, the sequencing question becomes sharper rather than softer. Which of those six approvals you obtain first now determines when Vietnam opens, alongside everything else that approval unlocks.

One caveat we are carrying openly. We verified this text through Vietnam's national legal document databases, which reproduce the official gazette, rather than through the ministry's own portal, which did not resolve. The provisions above are what that text says. Confirm the gazette copy before you build a filing plan on it.