Drug Registration in Vietnam: Guide for Foreign Companies (P2)

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DETAILED DRUG REGISTRATION PROCESS
Step 1: Preliminary assessment and preparation of documents
Before commencing the formal registration process, the following preparatory steps must be completed:

• Assess product suitability: Determine the product category (pharmaceuticals, biopharmaceuticals, vaccines, etc.) to apply the appropriate registration process.
• Check priority criteria: Determine whether the product qualifies for expedited review (e.g., drugs for life-threatening conditions, essential medicines, etc.).
• Prepare the ACTD dossier: Compile the ASEAN Common Technical Dossier (ACTD) with all four sections as required.
• Translate and legalize documents: All documents in foreign languages must be translated into Vietnamese and consular legalized.

Step 2: Submit the drug registration dossier
The drug registration application submission process includes the following steps:

• Pay the registration fee: Pay the document review fee in accordance with the current regulations of the Ministry of Finance.
• Submit the application online: Submit the application through the online public service portal of the Drug Administration Department (https://dav.gov.vn) or submit it directly at the Drug Administration Department.
• Receive application receipt: After submitting a valid application, the applicant will receive a receipt with an application number for tracking purposes.
• Submit testing samples: Send product samples to the Central Institute for Drug Control or the Ho Chi Minh City Institute for Drug Control (https://vienkiemnghiem.gov.vn/) for quality testing.

Step 3: Review of the registration application
The review process includes the following stages:

• Formality check: The Drug Administration conducts a review of the completeness and validity of the application (typically within 10–15 working days).
• Technical review: The Drug Registration Advisory Committee evaluates the technical aspects of the application.
• Sample testing: The Drug Testing Institute will conduct quality testing of product samples according to the registered standards.
• Request for additional information (if applicable): If the dossier does not meet the requirements, the Drug Administration will send a letter requesting additional information and clarification.

Step 4: Response to requests for additional information and revision of the dossier
Upon receiving the request for additional information, the registrant must:

• Analyze the requirements: Carefully review the additional requirements and explanations provided by the Drug Administration Department.
• Prepare the response: Compile explanatory documents and supplementary materials in accordance with the requirements, ensuring that all issues raised are fully addressed.
• Submit response: Submit the response within the specified timeframe (typically 6 months from the date of receiving the request letter).
• Monitor progress: Maintain communication with the Drug Administration Department to update the review progress after submitting the response.

Step 5: Attend the Registration Number Advisory Committee Meeting
After the review is completed, the dossier will be submitted to the Advisory Committee for consideration:

• AdvisoryBoard Meeting Schedule: The Advisory Board meets monthly to review dossiers that have completed the review process.
• Final Evaluation: The Committee will conduct a comprehensive assessment of the drug’s safety, efficacy, and quality.
• Committee Conclusion: The Committee issues a recommendation to grant or deny the registration number for the product.

Step 6: Issuance of the Registration Number
If the application is approved by the Committee:

• Issuance of Decision: The Drug Administration will issue a decision granting the drug registration number.
• Issuance of the Marketing Authorization Certificate: The Marketing Authorization Certificate for the drug is issued with a validity period of 5 years from the date of issuance.
• Publication of information: Information about the drug that has been granted a registration number will be published on the website of the Drug Administration Department.

Step 7: Post-registration procedures
After obtaining the registration number, the company must perform the following procedures:

• Drug price registration: Submit a price declaration for the drug before marketing the product.
• Import license application: For imported drugs, an import license must be obtained for each batch.
• Quality inspection of the first batch: The first batch of imported drugs must undergo quality inspection at the Drug Testing Institute.
• Establish a post-marketing surveillance system: Develop a system to monitor adverse effects and submit regular reports on drug safety.

SPECIAL DRUG REGISTRATION PROCEDURES
Drug registration via the simplified procedure
Certain types of drugs may be eligible for the simplified registration procedure:

• Applicable drugs: Drugs for urgent national defense, security, disease prevention, disaster relief, and rare drugs or drugs in national health programs.
• Simplified application dossier: Only the administrative and quality sections of the ACTD dossier are required, along with safety and efficacy documentation in accordance with the guidelines of the Drug Administration Department.
• Review period: Typically processed faster than the standard procedure (approximately 3-6 months).

Registration of reference/similar biological products
Registration process for reference/similar biological products (biosimilars):

• Comparative data requirements: Comprehensive comparative data with the approved reference product regarding quality, safety, and efficacy are required.
• Additional clinical studies: Typically requires equivalent pharmacokinetic, pharmacodynamic, and comparative clinical studies with the reference product.
• Risk management plan: A detailed risk management plan must be submitted, including risk mitigation measures and enhanced pharmacovigilance activities.

Generic drug registration
The registration process for generic drugs has several unique features:

• Demonstration of bioequivalence: For many oral dosage forms, a bioequivalence study report with a comparator drug is required.
• Quality standards: Must meet quality standards equivalent to or higher than those of the original brand-name drug.
• Reference drug: The reference drug must be the original brand-name drug or a reference drug accepted by the Drug Administration.

REGISTRATION COSTS AND TIMELINE
Drug registration costs
The costs to consider when registering drugs in Vietnam are specified in Decision 3246/QĐ-BYT, which lists additional administrative procedures and fees for the pharmaceutical, cosmetics, traditional medicine, and science and technology sectors under the Ministry of Health’s jurisdiction, as outlined in Circular 41/2023/TT-BTC:

• Document review fee: From 9,000,000 VND to 20,000,000 VND depending on the type of drug and registration form.
• Sample testing fee: From 3,000,000 VND to 15,000,000 VND depending on the testing method and the number of parameters.
• Drug information publication fee: Approximately 2,000,000 VND.
• Translation and legalization costs: Approximately 20,000,000 VND to 50,000,000 VND depending on the volume of documents.
• Consulting fees (if applicable): From 50,000,000 VND to 200,000,000 VND depending on the scope of services.

Drug registration timeline
Estimated timeline for the drug registration process in Vietnam in accordance with Circular 12/2025/TT-BYT on the registration of drugs and drug ingredients:

Generic drugs: 12–18 months from the submission of a complete application.
Brand-name drugs: 18–24 months.
Biological products and vaccines: 24–36 months due to more complex review requirements.
Drugs registered under the expedited procedure: 3–6 months in urgent cases.
Medicines registered under the fast-track review mechanism: 6–12 months for medicines on the priority list.

CHALLENGES AND SOLUTIONS
Common challenges
Foreign companies often face the following challenges when registering drugs in Vietnam:

• Frequent changes in regulations: The legal framework for pharmaceuticals in Vietnam is frequently updated, making compliance difficult.
• Language barriers: The requirement to translate all documents into Vietnamese is time-consuming and costly.
• Lengthy review process: Review times can be prolonged due to the volume of documentation and limited resources of regulatory authorities.
• Local data requirements: In some cases, data from studies on the Vietnamese population may be required.
  Post-registration changes: The approval process for changes is complex and time-consuming.

Solutions and effective strategies
To overcome these challenges, foreign companies can adopt the following strategies:

• Collaborate with experienced local partners: Select legal representatives with strong expertise and good relationships with regulatory authorities.
• Consult with the Drug Administration Department in advance: Organize pre-submission consultations to clarify specific requirements.
• Prepare high-quality documentation: Invest time and resources to prepare complete and high-quality documentation from the outset.
• Develop a long-term change plan: Anticipate and plan for changes after registration to minimize waiting time.
• Monitor new regulations closely: Stay updated on changes in regulations and prepare in advance for compliance.

REGULATIONS ON DRUG PRICING
Regulations on drug price declaration
After obtaining a registration number, the company must submit drug price declarations:

• Declaration timing: Before the drug is put into circulation and whenever there is a price change.
• Disclosure content: Includes the expected wholesale price, the expected retail price, and information on the components of the drug price.
• Price comparison: Information on drug prices in neighboring countries and worldwide must be provided.
• Price publication: Declared prices are publicly disclosed on the Drug Administration Department’s official website.

Drug price control

The drug price control mechanism in Vietnam includes:

• Drug price monitoring: The Drug Administration regularly monitors the implementation of drug price declarations and price fluctuations in the market.
• Price stabilization: In necessary cases, the regulatory authority may implement price stabilization measures for certain essential drug products.
• Drug tendering: Drugs used in public healthcare facilities must go through a tendering process in accordance with the regulations of the Ministry of Health.
• Bidding categories: Drugs are categorized into five bidding groups from 1 to 5 based on different criteria for quality and price.

CONCLUSION AND RECOMMENDATIONS
Summary of the process
The drug registration process in Vietnam is a complex procedure requiring thorough preparation and strict compliance with regulations. From the preparation of documents to obtaining the registration number, the process may take between 12 and 24 months, depending on the type of product.

Recommendations for foreign companies
Based on a comprehensive analysis of the drug registration process in Vietnam, we provide the following recommendations for foreign pharmaceutical companies:

• Conduct thorough market research: Before deciding to register a drug, it is essential to conduct thorough market research in Vietnam to assess potential and feasibility.
• Develop a long-term plan: Establish a long-term strategy for bringing the product to the Vietnamese market, including the post-registration phase.
• Select suitable partners: Choose local representatives with experience and credibility in the Vietnamese pharmaceutical industry.
• Join industry associations: Join associations such as the Vietnam Pharmaceutical Manufacturers Association (VNPCA) https://vnpca.org.vn/ or EuroCham’s Pharma Group (https://eurochamvn.org/vi/pharma-group-sector-committee-2/) to stay updated and expand your network.
• Strict compliance: Ensure full compliance with all regulations regarding drug registration, production, and distribution in Vietnam.

Outlook and future trends
The Vietnamese pharmaceutical industry is experiencing positive growth with the following trends:

• Digitalization of registration processes: Vietnam is gradually digitalizing its drug registration processes, reducing time and enhancing transparency.
• Harmonization of regulations with international standards: Vietnam continues to align its pharmaceutical regulations with international and ASEAN standards.
• Enhancing intellectual property protection: Vietnam is strengthening intellectual property protection for pharmaceutical products, creating a more favorable environment for innovative companies.
• Boosting domestic production: Policies encouraging domestic drug production may create opportunities for foreign companies to collaborate on production in Vietnam.

With a population of nearly 100 million and growing demand for healthcare, the Vietnamese pharmaceutical market remains a promising market for foreign pharmaceutical companies, despite the challenges of the drug registration process.

Harley Miller Law Firm is a professional law firm with years of experience in pharmaceutical legal matters in Vietnam. We provide comprehensive consulting services for foreign pharmaceutical companies seeking to register products and enter the Vietnamese market.

Our services

• Strategic drug registration consulting: Assessing and developing a tailored registration strategy for each product type and the company’s business objectives.
• Preparation and submission of registration documents: Assisting in the preparation of complete and accurate registration documents in accordance with the requirements of the Vietnamese Drug Administration.
• Legal representation: Acting as legal representative for foreign companies during the drug registration process in Vietnam.
• Regulatory consulting services: Providing advice on current regulations and updates on legal changes related to drug registration.
• Issue resolution support: Assist in resolving issues that arise during the registration process and respond 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.
• High success rate: Over 95% success rate in drug registration for foreign clients.
  Comprehensive services: Providing end-to-end solutions from initial consultation to post-registration support.
• In-depth market knowledge: Expert understanding of the Vietnamese pharmaceutical market and industry trends.

Workflow

• Initial consultation: Conduct an initial assessment of the product and determine the appropriate registration strategy.
• Plan development: Create a detailed timeline, resource allocation, and cost estimate for the registration process.
• Document preparation: Assist in preparing and finalizing registration documents according to the requirements of the Drug Administration.
• Submission and Monitoring: Submit the dossier and closely monitor the review process.
• Respond to requests: Timely respond to any additional requests or clarifications from the regulatory authority.
• Registration completion: Complete the registration process and assist with post-registration procedures.

Our Commitment

• Professionalism: Ensure professional, reliable, and efficient services.
• Transparency: Provide transparent information about processes, timelines, and costs.
• Security: Ensure the security of client information and data.
• Cost-effectiveness: Offer services at reasonable and cost-effective rates.
• Continuous Support: Assisting customers throughout the registration process and after completion.

Contact us for consultation: info@luatminhnguyen.com | Hotline: +84 937215585