The Vietnamese pharmaceutical market is in a phase of strong development with impressive growth rates, becoming an attractive destination for many foreign pharmaceutical companies. With a population of over 97 million people, an expanding middle class, and increasing health awareness, Vietnam represents a significant potential market in the Southeast Asia region.
However, to successfully penetrate the Vietnamese pharmaceutical market, foreign companies need to navigate the drug registration process – a complex procedure with many legal challenges. Understanding and properly complying with the registration process not only ensures product legality but is also a decisive factor in shortening time to market, saving costs, and creating a solid foundation for long-term development.
In Vietnam, the Drug Administration of Vietnam (DAV) under the Ministry of Health is the main agency responsible for managing, evaluating, and licensing pharmaceutical products. Vietnam’s pharmaceutical legal framework has undergone significant improvements in recent years, moving toward harmonization with international standards such as ASEAN and ICH, creating more favorable conditions for foreign manufacturers.
This article will provide a comprehensive and updated guide on the drug registration process in Vietnam for foreign pharmaceutical companies, reflecting the latest changes in the legal framework and technical requirements through 2025.
UNDERSTANDING THE PHARMACEUTICAL LEGAL FRAMEWORK IN VIETNAM
Overview of Pharmaceutical Law and Key Regulations
- Pharmaceutical Law No. 105/2016/QH13: This is the highest legal document governing all pharmaceutical activities in Vietnam, which has been amended and supplemented by Law No. 44/2024/QH15, passed by the National Assembly on November 21, 2024 and effective from July 1, 2025
- Decree 54/2017/ND-CP: Detailing certain articles and implementation measures of the Pharmaceutical Law (Some contents have been replaced or abolished by new documents, especially after the Pharmaceutical Law was amended in 2024)
- Decree 163/2025/ND-CP: replacing and updating many contents of Decree 54/2017/ND-CP, detailing and guiding the implementation of new provisions in the amended Pharmaceutical Law 2024 (Law No. 44/2024/QH15).
- Circular No. 12/2025/TT-BYT: replacing and updating Circular No. 32/2018/TT-BYT on registration of drugs and pharmaceutical ingredients.
- Circular 03/2023/TT-BYT: New regulations on evaluation and issuance of marketing authorization for drugs and pharmaceutical ingredients.
- Circular 29/2020/TT-BYT and its amendments: Regulations on importing drugs without marketing authorization in Vietnam.
- In 2024–2025, Vietnam has made significant updates to drug registration regulations, aiming to simplify administrative procedures, apply digital technology in the registration process, and harmonize with international standards.
Classification of Pharmaceutical Products
In Vietnam, drugs are classified into different groups, each with its own registration process and dossier requirements:
- New Chemical Entity (NCE): Drugs containing new active ingredients that have never been licensed in Vietnam.
Generic drugs: Drugs with the same active ingredients, dosage, and pharmaceutical form as the originator product and are usually registered through a simpler process.
- Biological products: Including vaccines, serums, blood products, biotechnology products…
- Herbal medicines: Drugs derived from medicinal materials, including traditional medicines and herbal products.
- Psychotropic drugs and precursors: This special group of drugs must comply with stricter regulations on control and monitoring.
Types of Registration
Vietnam currently has three main forms of drug registration:
- Standard registration: Applied to most types of drugs, requiring complete documentation and evaluation time of approximately 12-18 months.
- Abbreviated registration: Applied to certain cases such as generic drugs already licensed in reference countries (SRA), drugs in the centralized bidding list, drugs for national health programs.
- Fast-track/emergency registration: Applied to orphan drugs, drugs for urgent needs in epidemic prevention and control, rare drugs…
Updated Regulations Affecting Foreign Companies (2024–2025)
Notable changes in the 2024–2025 period include:
- Implementation of electronic submission: The online drug registration dossier submission system has been deployed, helping to simplify the process and reduce processing time.
- Acceptance of international clinical data: Vietnam is increasingly expanding the acceptance of clinical trial data conducted abroad, especially from ICH and ASEAN countries.
- ASEAN harmonization: Continued application of the ASEAN Common Technical Document (ACTD) format and implementation of commitments to harmonize pharmaceutical regulations within ASEAN.
- New data protection regulations: Enhanced regulations on data protection and intellectual property rights protection for new pharmaceutical products.
- Pharmacovigilance requirements: Foreign companies need to establish pharmacovigilance systems in compliance with Vietnam’s new regulations on adverse reaction reporting and drug safety monitoring.
PRE-REGISTRATION REQUIREMENTS
Legal Entity Requirements for Foreign Companies
To proceed with drug registration in Vietnam, foreign pharmaceutical companies need to meet the following legal entity requirements:
- Have legal representation in Vietnam: Foreign companies must have an official representative office in Vietnam or authorize a Vietnamese pharmaceutical company as their registration representative.
- Pharmaceutical business license: The representative entity must have a pharmaceutical business license issued by the Drug Administration of Vietnam with appropriate scope of activities.
- Pharmaceutical practice certificate: The technical supervisor of the representative entity must have an appropriate pharmaceutical practice certificate.
- Authorization contract: The authorization contract between the foreign manufacturer and the representative entity in Vietnam must be notarized, legalized by consular authentication, and translated into Vietnamese.
List of Documents to Prepare
Prepare the following documents completely before starting the registration process:
- Drug registration application: According to the format prescribed by the Drug Administration of Vietnam.
Certificate of Pharmaceutical Product (CPP): Issued by the competent drug regulatory authority of the country of origin, still valid.
- GMP certificate: Of the manufacturing facility, still valid and issued by the competent authority.
- Technical dossier: In ACTD format, including all 4 parts (Administrative, Quality, Preclinical, Clinical).
- Sample labels and package inserts: In Vietnamese, complying with Vietnam’s drug labeling regulations.
- Product samples: In quantities as required for testing and evaluation.
- Registration fees: Receipt of dossier evaluation fee and testing fee (if any).
GMP/GDP Certification Requirements
Vietnam has strict requirements for GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice):
- Recognized GMP standards: Vietnam recognizes WHO-GMP, EU-GMP, PIC/S-GMP, Japan-GMP, US-cGMP, and equivalent standards.
- GMP validity period: The GMP certificate must be valid at the time of submission and for at least 6 months thereafter.
- GMP inspection: In some cases, the Drug Administration of Vietnam may conduct GMP inspections at foreign manufacturing facilities before granting approval.
- GDP requirements: For companies distributing drugs in Vietnam, a Good Distribution Practice (GDP) certificate issued by the Drug Administration of Vietnam is required.
Certificate of Pharmaceutical Product (CPP) Requirements
CPP is one of the most important documents in the drug registration dossier in Vietnam:
- CPP issuing source: CPP must be issued by the competent drug regulatory authority of the country of origin or reference country according to WHO format.
- Validity period: CPP must be valid at the time of submission (usually required to be valid for at least 12 months).
- Information on CPP: Must clearly confirm that the drug has been licensed and is being marketed in the CPP-issuing country, and that the manufacturing facility complies with GMP.
- Consular legalization: CPP must be consular legalized and translated into Vietnamese by a licensed translation agency.
Local Representative Requirements for Foreign Manufacturers
All foreign pharmaceutical manufacturers must have a local representative in Vietnam:
- Types of representation: Can be a representative office of the foreign company in Vietnam or an authorized Vietnamese pharmaceutical company.
- Scope of responsibilities: The representative is responsible for product quality, conducting pharmacovigilance activities, handling complaints, and product recalls when necessary.
- Personnel requirements: The representative must have professional staff meeting qualification and experience requirements as stipulated by the Pharmaceutical Law.
- Authorization contract: The contract between the manufacturer and representative must clearly state the rights and obligations of both parties, especially responsibilities regarding drug quality and safety.
- Authorization term: The authorization term should typically cover the entire period the product is marketed in Vietnam (at least 5 years).
Harley Miller Law Firm is a professional law firm with many years of experience in pharmaceutical legal matters in Vietnam. We provide comprehensive consulting services for foreign pharmaceutical companies looking to register products and enter the Vietnamese market.
Our Services
- Drug registration strategy consulting: Evaluating and developing appropriate drug registration roadmaps for each product type and company business objective.
- Preparation and submission of registration dossiers: Supporting the preparation of complete and accurate registration dossiers according to the requirements of the Drug Administration of Vietnam.
- Legal representation: Acting as legal representatives for foreign companies during the drug registration process in Vietnam.
- Regulatory consulting services: Advising on current regulations and updates to legal changes related to drug registration.
- Problem-solving support: Assisting in resolving issues that arise during the registration process and responding to additional requests from regulatory authorities.
- Specialized translation services: Providing specialized pharmaceutical translation services for technical and legal documents.
Advantages of Harley Miller Law Firm
- Experienced team of experts: A team of lawyers and pharmaceutical experts with over 15 years of experience in drug registration in Vietnam.
- Extensive network: Close relationships with regulatory agencies and pharmaceutical industry associations, helping to facilitate the drug registration process.
- High success rate: Success rate of over 95% in registering drugs for foreign clients.
- Comprehensive services: Providing end-to-end solutions from initial consultation to post-registration support.
- Deep market understanding: In-depth knowledge of the Vietnamese pharmaceutical market and development trends.
Working Process
- Initial consultation: Preliminary assessment of the product and identification of appropriate registration strategies.
- Planning: Developing detailed plans regarding time, resources, and costs for the registration process.
- Dossier preparation: Supporting the preparation and completion of registration dossiers according to the Drug Administration’s requirements.
- Submission and monitoring: Submitting dossiers and closely monitoring the approval process.
- Responding to requests: Promptly responding to additional requests or clarifications from regulatory authorities.
- Completing registration: Finalizing the registration process and supporting post-registration procedures.
At Harley Miller Law Firm, we commit to:
- Professionalism: Ensuring professional, reliable, and effective services.
- Transparency: Providing transparent information about processes, timelines, and costs.
- Confidentiality: Ensuring the confidentiality of client information and data.
- Cost-effectiveness: Providing services at reasonable and efficient costs.
- Continuous support: Supporting clients throughout the registration process and after registration completion.
Contact for consultation: info@luatminhnguyen.com | Hotline: +84 937215585 Email: miller@hmlf.vn
