The dossier that satisfied your home regulator is not the dossier Vietnam wants. That sentence costs more first-time entrants a year than any other.
Rejection is rare. Delay is normal.
A well-made product from a competent manufacturer very seldom gets refused. What happens instead is a query, then a response, then another query, and a submission that was expected to take one cycle takes three. Each round trip is measured in months, and each one is usually caused by something administrative rather than scientific.
Where the time actually goes
Format, not content. The Drug Administration of Vietnam expects the ACTD structure. A dossier assembled for a different regulator contains the same information arranged differently, and rearranging it after submission is slower than doing it first.
Legalisation. Certificates of pharmaceutical product, GMP certificates and manufacturing licences need to be legalised, and the chain of legalisation is done in the country of origin. It cannot be started once the query arrives; by then you are already waiting.
Stability data under the right conditions. Vietnam is Zone IVb. Data generated for a temperate climate is data for somewhere else.
Consistency between documents. A manufacturing site named slightly differently on two certificates, a strength written two ways, a batch size that does not match between the dossier and the GMP certificate — each is a query, and each query is a cycle.
Why we do not quote you a date
We are sometimes asked for a registration timeline before any work has started. We do not give one, and we would treat a competitor who did with some suspicion. The timeline belongs to the regulator, it varies by product class, and it depends more than anything on how complete the file is on the day it is filed.
What we will tell you, before anything is spent, is whether we think the product is worth registering in this market at all. That answer is free, and about a third of the time it is no.
