Vietnam is the 7th fastest growing middle-class population in the world and aims to achieve an upper middle class income status by 2035, one of major market drivers of high-quality healthcare products.
- Free trading agreement between the European Union and Vietnam, European Union Vietnam Free Trade Agreement (EVFTA), has paved the way for foreign companies to import and sell pharmaceutical products to distributors in Vietnam.
- Under the EVFTA agreement, distributors are allowed to sell pharmaceutics without additional testing or certification for certain products that are already certified by the EU.
Pharmaceutical Regulations and Registration in Vietnam
Let us to understand who oversees pharmaceuticals in Vietnam and how drugs are classified. This helps make sense of the rules before starting with the product registration in Vietnam.
Vietnam Pharmaceutical Regulatory Authority
Pharmaceutical Regulatory Authority in Vietnam is The Drug Administration of Vietnam (DAV). This Vietnamese regulatory authority is responsible for the drug approval process in the country. The DAV is a decentralized body under the Ministry of Health (MOH), also called “Bộ Y Tế” in Vietnamese which literally means ‘Medicine’. All pharmaceutical products in Vietnam are required to be approved by the DAV and all imported products are required to get an ‘Import Permit’ from the DAV.
Drug Classification System In Vietnam
Legal classification of drugs as per the Circular 20/2017/TT-BYT:
- OTC (Over-the-Counter) Drugs: They are drugs that can be given to the consumers and there is no need for any prescription to get this drug. This is because they are generally considered as safe medicines for self-medication. These are drugs that are used in common conditions like common cold, headache…
- Prescription Drugs: These are medications that are dispensed to patients upon the receival of a valid prescription from a doctor. This is because it can cause side effects, can interact with drugs, food or can be contraindicated in certain disease conditions which can be known only by a doctor. It needs medical supervision.
- Traditional Herbal Medicines: These are traditional medicines that are obtained from plants with medicinal value. Some of the traditional herbal medicines are regulated by the Ministry of Health, Vietnam, because they are considered as pharmaceutical drugs.
- Controlled Drugs: They are drugs which are under strict regulatory guidelines in Vietnam. The activities concerned with controlled drugs (manufacturing, distribution, prescription) are regulated with special controls set by the regulatory authority/government. This is because they are easily subjected to dependence, abuse or cause serious harm when not regulated properly.
Types Of Drugs In Vietnam:
Types of controlled drugs in Vietnam as specified in article 3 of Circular 20/2017/TT-BYT:
- Narcotic drugs – Drugs that contain narcotic active ingredient(s) or any drug that contains both active ingredient(s) and psychotropic active ingredient(s) regardless of availability of drug precursors
- Psychotropic drugs – Drugs that contain one or some psychotropic active ingredient(s) or drugs that contain both psychotropic active ingredient(s) and drug precursor(s).
- Precursor drugs – Any drug that contains one or some drug precursors
- A combined drug – Drugs that contain narcotic active ingredient(s) or both narcotic active ingredient(s) and psychotropic active ingredient(s), regardless of availability of drug precursors
Note: All drug ingredients and concentrations are specified in Appendix I – VI of Article 3 of Circular 20/2017/TT-BYT
Required Documents for Vietnam Drugs Registration
The documents required for the pharmaceutical products registration process in Vietnam is given below:
- Application for registration
- Authorization Letter
- Certificate of operating in medicine, medicine raw material in Vietnam
- Certificate of Eligibility for pharmacy business
- License for pharmaceutical establishment of a representative office in Vietnam
- Certificate of Pharmaceutical Product (CPP) o FSC Certificate if foreign medicine company does not have CPP
- GMP and GLP compliance certificates
- Drug substance and drug product information including general information, description, composition
- Labeling materials
Pharmaceuticals Registration Process In Vietnam
Following are the steps for Pharma products registration in Vietnam are described below.
Submission of Application by Pharmaceutical establishment to the Department of Management Pharmacy, MOH
Review and evaluation: Within 12 months from the date of the submission of the application, the DAV shall: a) Organize the appraisal of the registration dossier and forward it to the Advisory Council for the grant of a drug registration certificate for the application for issuance.
Note: All documents must be presented in Vietnamese. If it’s in a foreign language, documents shall be translated into Vietnamese.
Validity of the drug license: Validity of the drug license is maintained through an Online system where the drug validity is published online. Typically, the validity for a drug is granted for 12 months post which the continued validity of the old license shall be granted upon successful re-review.
Also Read: Medical Device Registration Guidelines In Vietnam
Vietnam New Regulations on Drug Registration
Vietnam’s Ministry of Health has issued Circular 12/2025/TT-BYT, bringing notable changes to drug and drug material registration. This replaces multiple previous circulars and comes into effect from July 1, 2025.
- Circular 12 replaces Circular 08/2022/TT-BYT, Circular 16/2023/TT-BYT, and Circular 07/2017/TT-BYT
- Fixed OTC drug list is removed; classification now based on defined criteria and methods
- Existing drug classifications remain valid until the MA is renewed
- Reclassification requires a variation dossier submission to the DAV
- Dossiers under review will follow new classification rules from Circular 12
- Only one CPP is required, issued by manufacturing country or an SRA/EMA member
- CPP must confirm the drug is licensed and currently marketed in the issuing country
- Dossiers referencing EMA/SRA approvals must be filed within 5 years of original approval
- Such dossiers need an assessment report and comparison table of similarities
- MA extensions can now be submitted any time before expiry
- Companies have 6 months to respond to DAV deficiency letters
- Only two supplementation rounds allowed; third only if new points arise in second
- Limits on supplementation do not apply if the Advisory Council requests changes
Also Read: DAV Updates New Drug Registration Process in Vietnam
Pharma Clinical Trial Requirements by MoH
The Ministry of Health (MOH), particularly the Administration of Science, Technology and Training (ASTT), handles clinical trial approvals, site registrations, and inspections.
MOH approval needed for all trial phases (I–IV).
Ethics clearance from NECBR and institutional EC.
Submit full trial dossier for review.
ASTT inspects for safety and data integrity.
Written informed consent from participants.
Import license required for unregistered drugs.
Follow GCP and local regulations.
Drug Authorization fees by MoH
As per the fee announcement for pharmaceutical field to be implemented from August 1, 2023 in Vietnam, the applicable fee rate is as follows:
| Type of Authorization | Fee in VND | Fee in USD |
| Appraisal & issuance for drug circulation registration certificate (NA for traditional medicines) | 11 million/file | 429 USD approx. |
| Appraisal of renewal of circulation registration paper for drugs, traditional medicines and medicinal ingredients | 4.5 million/file | 175 USD approx. |
| Import License appraisal and issuance for drugs which do not have a drug circulation registration certificate in Vietnam | 1.2 million/item | 47 USD approx. |
Drug Import and Distribution In Vietnam
- Before anything hits Vietnam, your drug needs to be registered with MOH—no shortcut there.
- If you’re coming from outside, you must have someone local on the ground. Think of them as your go-between for all the paperwork.
- Once imported, drugs have to be handled right—temperature, storage, record-keeping… all that GDP stuff matters.
- You’ll also need an import license from MOH, and yes, you’ll announce wholesale prices before your first shipment—and update them if they change.
Important documents required to procure Import License
The following are the documents needed for obtaining an import license in Vietnam:
- Business Registration Certificate
- Import Declaration Form
- Proforma Invoice
- Packing List
- Bill of Lading (B/L) or Air Waybill (AWB)
- Certificate of Origin
- Quality and Safety Certificates
- Pharmaceutical Product Registration Certificate
- Power of Attorney
Labelling of Pharma Products In Vietnam
The following information must be mandatorily included in the primary packaging of the drug:
- Name of the drug
- Composition of the drugs, the contents, the concentration or weight of the active or herbal ingredients.
- Batch number
- Expiry date and the name of the manufacturer.
The following is the information that must be contained mandatorily in the secondary packaging of drugs:
- Name of the drug
- Dosage form
- Composition of the drugs, the contents, the concentration or weight of the active or herbal ingredients.
- Contents of the package
- Indication, instruction for use, contraindications
- If available, registration number or import license
- Manufacturing and expiry date, batch number, quality standards, storage conditions
- Precautions and recommendation, if any
- Manufacturer name and address (Importer name and address for imported drugs)
- Drug origin
DAV Renewal of Pharma Products In Vietnam
Timing for Renewal: The renewal process must be initiated before the expiry date of the drug registration.
Submission of Renewal Application: A renewal application must be made to the Drug Administration of Vietnam by the Marketing Authorization (MA) holder. The applications can be submitted online, by post or in person. It must include all relevant and latest information about the drug along with amendments made post initial registration (if any).
Payment of Fees: Renewal of drug registration in Vietnam usually requires the payment of applicable renewal fees of approximately $175 USD.
Evaluation and Approval: After receiving the complete dossier, the DAV within 3 months grants the extension of registration certificate. The evaluation process includes the involvement of appraisal experts, and advisory council whenever applicable. A written response stating the reasons clearly is given in case of unsatisfactory dossier.
Validity Period: After the renewal approval, the drug registration certificate remains valid for the next 5 years from the expiry date of prior registration.
Registration Process for Drugs approved in the EU/US is Streamlined
The regulatory authorities like the EMA (European Medicines Agency) in the EU and FDA (Food and Drug Administration) in the US have stringent regulations set forth for the approval of drugs. So, if any drug that has been approved by these regulatory authorities is considered as drugs with appropriate safety, efficacy and quality. This provide a great advantage for the approval of such drugs in Vietnam which are:
- Expedited Review Process: For drugs that have gained a successful approval from EMA or FDA or any other regulatory authorities which are acceptable by the regulatory authority of Vietnam (MHRA, PMDA…), might be able to undergo an expedited or streamlined approval process. This also benefits by saving the time and money required otherwise.
- Reference for Quality and Safety: It is well known that the above stated regulatory authority’s approval process is such that it demands evidence for quality and safety for the products introduced into the market. Rigorous testing, documentation and evaluation procedure conducted for the drug facilitates the approval process in Vietnam.
- International Standards Recognition: The Drug Administration of Vietnam takes the approval of a drug from strict regulatory authorities like the FDA and EMA into consideration. It is because they align with the widely recognized international best practices.
- Scientific Data Exchange: The regulatory authority of Vietnam allows the submission of the data priorly submitted to the EU or US since it has already proved the safety and efficacy of the drugs. This allows to save time by avoiding the submission of unnecessary data and thereby speeding up the review process.
- Improved Credibility: Since the EMA and FDA are trusted regulatory authorities due to the evidence they demand in an approval process, the drugs approved by them are also trusted for its safety, quality and efficacy. It gives credibility and confidence for its use among the stakeholders.
- Possible Waiver of Certain Studies: Considering that a drug has undergone extensive and exhaustive evaluation procedures under EMA and FDA for its approval, the Vietnamese regulatory authority provides a favour of waiving certain studies like the clinical and pre-clinical in some cases.
Also Read: Medical Device Registration Services In Vietnam
DAV Post-Market Surveillance
- After your drug hits the market, MOH (via NDIADRMC) keeps tabs on it—so ADRs don’t go unnoticed.
- If someone reports an adverse reaction, that data gets screened for patterns—this is how safety signals get spotted.
- Once something odd pops up, regulators check how big the risk is and share updates with doctors and health pros.
- You also pull together PSURs and a Risk Management Plan—just part of staying on top of real-world safety.
- The system’s still growing but has already helped catch issues and prompted updates based on actual practice here.
Also Read: Nutraceutical Regulations in Vietnam
FAQ’s
Q. How are drugs monitored after approval in Vietnam?
Some of the activities performed for the post market surveillance of drugs in Vietnam are ADR reporting, safety signal detection, risk management plan development and implementation, risk assessment and proper communication, and timely submission of PSUR’s.
Q. Who handles ADR reporting in Vietnam?
Since 2009, the job has been with the National Drug Information and Adverse Drug Reaction Monitoring Centre (NDIADRMC). Before that, the Drug Administration of Vietnam was the one collecting spontaneous ADR reports.
Q. Does DAV alone review all the dossiers submitted to them?
The dossiers when submitted to DAV will get forwarded to the appraisal unit or appraisal experts. They then conduct thorough evaluation and send it back to the DAv along with the appraisal records. The DAV then has to summarise the record and make a decision to grant the license/ registration or not to grant.
Q. Is it important to appoint a local agent in Vietnam?
A. Yes, it is important to appoint a local agent or representative in Vietnam for foreign manufacturers/importers/distributors. This is because it requires the documents to be submitted in Vietnamese. Apart from that the Local Authorized Representative can provide better understanding of the Vietnam market, regulatory requirements and consultation meetings with regulatory authority (if any).
