Vietnam’s pharmaceutical sector has experienced consistent growth over the past decade, spurred by rising healthcare demands, government initiatives to modernize the healthcare system, and increased foreign investment. For international pharmaceutical companies aiming to enter this emerging market, a deep understanding of Vietnam’s regulatory environment is essential.

Regulatory Oversight in Vietnam’s Pharmaceutical Sector

Drug regulation in Vietnam falls under the jurisdiction of the Drug Administration of Vietnam (DAV), which operates under the Ministry of Health (MOH). The DAV plays a central role in overseeing pharmaceutical product approvals, clinical trial oversight, and issuing import permits for foreign-manufactured drugs. Whether introducing a new molecule or a generic, companies must secure authorization from the DAV before commercializing any pharmaceutical product in the country.

All imported pharmaceutical products must obtain an import license, even if they have already been approved in other jurisdictions. No pharmaceutical can be legally marketed in Vietnam without going through this process.

Classification of Pharmaceutical Products

Vietnam organizes drugs into several categories based on their intended use, formulation, and risk level. These classifications are critical, as they determine how a product is regulated and what kind of controls or additional documentation are required.

1. Over-the-Counter (OTC) Drugs

OTC products can be dispensed without a prescription and are typically used for minor ailments such as headaches, colds, or digestive discomfort. These drugs are considered safe for self-medication when used as directed and usually have a long-standing record of safety.

2. Prescription-Only Medicines (Rx)

Prescription drugs must be dispensed based on a valid medical prescription. They often require close monitoring due to potential interactions with food, other medications, or existing health conditions. Their use is limited to healthcare settings or under the guidance of licensed healthcare professionals.

3. Traditional and Herbal Medicines

Vietnam has a strong tradition of herbal medicine, and many products derived from medicinal plants are recognized under the official regulatory framework.

4. Controlled Substances

Drugs with the potential for dependency, abuse, or serious side effects fall under the category of controlled substances. These include Narcotics, Psychotropics, etc.

Clinical Trial Oversight and Requirements

If a foreign drug company has done clinical work in the West or Japan, it is likely to be accepted for drug registration in Vietnam. If local clinical trials are needed in Vietnam, please see below.

Clinical research involving pharmaceuticals must follow stringent oversight mechanisms in Vietnam. All clinical trial protocols, whether domestic or part of an international study, require formal approval from the MOH unless exempt.

Approval Process

• Regulatory Review: All phases of clinical trials (I-IV) must be approved by the MOH’s Department of Science, Technology and Training (ASTT).
• Ethical Review: In addition to regulatory approval, trial protocols must undergo ethical assessment by the National Ethics Committee in Biomedical Research (NECBR) or institutional ethics boards.
• Informed Consent: Participants must provide informed consent in accordance with international ethical standards, ensuring they understand the risks, procedures, and purpose of the trial.
• Inspection: The ASTT may conduct inspections to evaluate participant safety and data integrity.

Step-by-Step Guide to Drug Registration

Securing approval for pharmaceutical products in Vietnam involves a detailed registration process. All documents must be provided in Vietnamese or accompanied by certified translations.

Required Documentation

• Registration Application Form
• Letter of Authorization for local representation
• Business Licenses (for pharmaceutical activities, either for local entity or representative office)
• Certificate of Pharmaceutical Product (CPP) or Free Sale Certificate (FSC) for foreign products
• GMP and GLP Certificates, demonstrating compliance with manufacturing and laboratory standards
• Comprehensive Product Dossier detailing:
  • Composition
  • Product specifications
  • Manufacturing process
  • Stability data
  • Labels and packaging information

Submission and Review

Once the registration dossier is prepared, it must be submitted to the Department of Pharmaceutical Management under the MOH. The DAV has a 12-month window to review the application and issue a drug registration certificate, although timelines can vary based on product type and dossier completeness.

Once approved, drug licenses are digitally published, and product validity can be verified through the online MOH system.

Maintaining Drug Registration Validity

Drug licenses in Vietnam are typically valid for one year. However, renewal is possible through an updated review process before expiration. Companies must initiate the renewal process in a timely manner to avoid disruptions in supply and marketing.

Ongoing compliance with labeling regulations, product information updates, and pharmacovigilance requirements is essential to maintain a product’s status in the market.

Importation and Distribution Regulations

Once a product is registered, it can only be imported and distributed in Vietnam under strict regulatory guidelines. Key requirements include:

1. Local Representation
   Foreign pharmaceutical companies must appoint a Local Authorized Representative (LAR) or a licensed distributor to act on their behalf. This entity handles communication with the DAV, assists with regulatory submissions, holds the foreign registrations after approval, and manages post-market responsibilities.
2. Import License
   Each drug requires an import license prior to entry into Vietnam. The license may apply to a single product or cover multiple items, depending on the scope of the application. Licenses must be renewed periodically, and product details must match those submitted during registration.
3. Wholesale Price Notification
   Before launching a product, companies must declare their wholesale prices to the MOH. This is a critical compliance step, especially for price-sensitive medications or those reimbursed by public or private health insurance programs. Any changes to pricing must also be declared.
4. Good Distribution Practice (GDP) Compliance
   Companies distributing pharmaceuticals in Vietnam must adhere to GDP guidelines to ensure drug safety, quality, and traceability across the supply chain. This includes appropriate storage conditions, transportation protocols, and recordkeeping.

Recent Regulatory Update: Streamlined Drug Registration Process

On May 16, 2025, Vietnam’s Ministry of Health issued Circular No. 12/2025/TT-BYT, introducing significant updates to the drug registration system aimed at improving efficiency and aligning with international standards.

The fixed list of over-the-counter (OTC) drugs has been replaced with a principles-based classification system, which considers safety, misuse potential, and intended use. Existing OTC classifications remain valid until the next marketing authorization (MA) renewal, at which point reassessment under the new framework will occur.

Only one Certificate of Pharmaceutical Product (CPP) is now required—from either the country of manufacture or a Stringent Regulatory Authority (SRA) such as the US FDA, the European Medicines Agency (EMA), and Japan’s PMDA. Additionally, registration applications must be submitted within five years of approval by an SRA.

Circular 12 limits applicants to two rounds of supplemental documents to address regulatory deficiencies, with a third allowed only if new issues are raised. Each round must be completed within six months to avoid application rejection.

 Conclusion

Navigating Vietnam’s pharmaceutical regulatory framework requires preparation, precision, and local expertise. While the registration process is rigorous, recent digitalization efforts and regulatory reforms are making it more transparent and manageable.

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Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)

Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.