Drug registration

On July 29, 2026 the Ministry of Health of Vietnam (MOH) issued Circular No. 32/2026/TT-BYT on registration of drugs and medicinal ingredients (“Circular 32”). Circular 32 shall take effect as from October 1, 2026 and replace Circular No. 12/2025/TT-BYTT on the same subject. The drug registration process in Vietnam is simplified, particularly for foreign applicants, following the issuance by of Circular 32.

Key provisions of Circular 32 are as follows.

1. Data protection

Circular 32 updates data protection guidelines according to which new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization approval. Subsequent applications that rely on the originator's protected data will not be eligible for approval from the date of submission of the originator's registration dossier until five years after the first marketing authorization is granted.

Circular 32 requires the regulatory authority to publicly disclose information on subsequent applications five months before the granting of the marketing authorization, providing originator companies with an opportunity to exercise and enforce their intellectual property rights.

2. Exemption from legalization requirements for foreign documents

Legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities.

This Circular also permits the submission of electronic notarized copies of legal documents in registration dossiers as an alternative to hard-copy notarized documents.

3. Postponement of CPP submissions

For new drugs and certain specified cases, applicants may postpone submission of a certificate of pharmaceutical product (CPP) at the time of initial dossier filing by providing a written justification explaining its absence. However, the CPP must be submitted no later than the second round of dossier supplementation in order for the application to remain eligible for marketing authorization approval.

4. Other important issues

- Applicants are exempt from submitting legal documents demonstrating GMP compliance for ingredient manufacturers where finished products are used pharmaceutical ingredients that have already been granted marketing authorization in Vietnam, and strictly complies with the approved information (including ingredient name, manufacturer, specifications, and source),

- For imported drugs and medicinal ingredients, products may continue to be imported and circulated until their expiry date, provided they were dispatched from the port of export before the mandatory implementation deadline.

- Upon receiving an official refusal decision for a new registration, renewal, or variation application, applicants will have one month to submit a written explanation requesting reconsideration. If the explanation is accepted by the Advisory Council, the application may be approved directly without requiring the applicant to prepare and submit a completely new dossier. This new re-examination mechanism is expected to reduce the administrative burden, shorten approval timelines, and improve overall regulatory efficiency.