Registration Of Drug Product In Vietnam (2025)

Overview

In Vietnam, the registration of a drug product is regulated by the Drug Administration of Vietnam (DAV), under the Ministry of Health (MOH).

The registration process requires submission of a comprehensive dossier in the ASEAN Common Technical Dossier (ACTD) format, organized into four main parts (Parts I to IV), covering administrative, quality, safety, and efficacy information of the drug product.

Pharmaceutical companies seeking to market a drug in Vietnam must submit a comprehensive dossier that includes detailed information on the drug’s quality, safety, efficacy, manufacturing process, and labeling. The registration process begins with a formal application that is reviewed for completeness before technical evaluation by experts. This evaluation assesses the scientific data, clinical trial results, and compliance with Vietnamese regulations and Good Manufacturing Practices (GMP). Additionally, imported drugs must have marketing authorization in their country of origin or other recognized markets. The approval timeline can vary depending on the drug category, with innovative or new chemical entities typically requiring more extensive review. Once approved, the product is granted a registration certificate valid for a specific period, after which renewal is necessary. Post-registration, companies must comply with ongoing pharmacovigilance and reporting requirements to ensure continued drug safety and efficacy in the Vietnamese market. Overall, the process aims to ensure that only safe, effective, and high-quality pharmaceutical products are available to Vietnamese patients.

Registration Process

Online Submission

To submit a fresh registration application to the Drug Administration of Vietnam (DAV), access the DAV Online System: https://dichvucong.dav.gov.vn

Before logging into the online system, ensure that your company has a registered and activated account on the DAV portal, and that a valid USB Token is properly installed and ready for use in digital signing.

Registration Dossier Structure (Vietnam - DAV)

The fresh registration dossier must be organized into four main parts as per DAV and Circular 32/2018/TT-BYT:

Part I – Administrative Information

• Cover letter, application form

• Legalized documents (CPP, GMP, LOA)

• Company, MAH & manufacturer details
  

Part II – Quality Documentation

• CTD Modules 2 & 3

• API/Finished product specs, CoA, validation & stability data

• Packaging and labeling details
  

Part III – Non-Clinical Data

• Toxicology & pharmacology reports

• Other safety data (if applicable)
  

Part IV – Clinical Data

• Clinical trial or literature data

• Bioequivalence (BE) reports

• Efficacy and safety summaries

Note:

• Documents should be in A4 size, firmly bound, and separated by tab dividers.

• A table of contents (Form 5/TT) should precede the dossier.

• The structure complies with the CTD (Common Technical Document) format adapted for Vietnamese regulations.

Registration Fees

Fresh Registration
Fee: 5,500,000 VND (~ 220 USD).

Variation Submission (MiV or MaV)
Fee: 1,200,000 VND (~ 48 USD) per variation dossier

5-Year Visa Extension
Fee: 1,500,000 VND (~ 60 USD).

Pre- Submission

Submission

Evaluation

Fee Payment

Post Decision