Market Watch: Vietnam's reliance route is now in force

What changed. Vietnam's new drug registration circular took effect on 1 October 2026. It allows an abbreviated assessment for products already approved by a recognised foreign authority, verifying technical consistency with the reference approval rather than running a full technical review.¹

Circular 32/2026/TT-BYT was signed on 29 July 2026.

The recognised set is broader than most summaries say. Article 2, clause 9 covers the European Medicines Agency; the ICH members as at 23 October 2015, being the US FDA, EU member state regulators, the UK MHRA and Japan's PMDA; the ICH observers Swissmedic and Health Canada; and the mutual recognition arrangement countries Australia, Iceland, Liechtenstein and Norway.¹

That is wider than the "six stringent regulators" formulation in circulation, including in our own earlier note on this circular, which we got wrong. An approval from an individual EU member state regulator qualifies, as do four mutual recognition routes the shorter list leaves out.

What it does. Marketing authorisation validity extends to five years with automatic continuation where renewal is filed before expiry, multiple pack sizes and manufacturing sites can sit under one registration, and the circular adds cases exempt from submitting safety and efficacy documentation in the registration dossier.^{1 2}

What to do now. If you hold a qualifying approval, Vietnam moves earlier in an Asian launch sequence than it has historically sat, and reliance routes are least congested in their first year. Assemble the reference evidence pack now: approval letter, approved labelling, assessment report.

Then check the exemption provisions against your own dossier, because that is where the time actually comes out.

If you hold no approval from the recognised set, the sequencing question sharpens rather than softens. Which approval you obtain first now determines when Vietnam opens, alongside everything else that approval unlocks.

One caveat we are carrying openly. We verified this through Vietnamese legal databases that reproduce the official instrument rather than through the ministry portal, which did not resolve. The headline position, that the circular is in force, is solid. Before building a filing plan on the clause-level list above, have it checked against Cong bao or the Ministry of Health directly.