Pharmaceutical Regulations and Registration in Vietnam
- Oindrila Ghosal
- Jul 29, 2023
- 9 min read
Updated: Apr 16
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’s take a look at the regulatory authority that governs the pharmaceuticals and know about the drug classification in Vietnam.
Pharmaceutical Regulatory Authority in Vietnam
The Drug Administration of Vietnam (DAV), the 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 are required to be approved by the DAV and all imported products are required to get an ‘Import Permit’ from the DAV.
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. 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 controlled drugs as specified in article 3 of Circular 20/2017/TT-BYT:
Types of controlled drugs 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
Clinical Trial Requirements
MOH evaluates and grants approval for all medicines to be used in clinical trials (Phases I-IV) unless considered exempt by the agency. The drugs must also have been approved by a Science and Technology Council or an Ethics Committee dedicated to medicine as effective and safe to treat traditional medical diseases.
Clinical Trial Review Process includes submission of dossier and review.
Inspection – The Administration of Science, Technology and Training (ASTT) undertakes the inspection to ensure:
the protection of the rights and health of participants;
the quality and integrity of the research data
Ethics Committee - evaluates the trial protocol to ensure that the rights, safety, and well-being of participants are protected. The MOH’s National Ethics Committee in Biomedical Research (NECBR) and institutional level ECs (known as Councils of Ethics in Biomedical Research at the Grass Root Level and CEBRGL) evaluate clinical trial documentation and charges fee of approximately $1,000-$2,000 USD.
Informed Consent: Participants in the clinical trial must provide informed consent before enrollment. The informed consent process should be conducted in accordance with international ethical standards.
Registration Process For Pharmaceutical Products:
The documents required for the registration process is given below following which steps for registration are described below.
Required Document for registration
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
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.
MOH Drug Authorization fees
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 Requirements
Drug Registration: Before importing and distributing drugs in Vietnam, the drug product must be registered with MOH.
Local Representative: It is required to appoint a local representative known as the Local Authorized Representative (LAR) or a licensed distributor for foreign drug manufacturers and importers wishing to market their drug in Vietnam. The local representative serves as the liaison between the company and the Vietnamese regulatory authorities.
Good Distribution Practice (GDP): Companies engaged in drug distribution must adhere to Good Distribution Practice guidelines to ensure the proper handling, storage, and transportation of drugs throughout the supply chain.
Import License: Importers must obtain an import license issued by the MOH before bringing drugs into Vietnam. The license may be specific to a particular drug or a range of drugs and is subject to renewal. The importers before launching their first batch in Vietnam, must announce their wholesale price to MOH. The wholesale prices must be renounced when there is a change in the price.
Important documents required to procure Import License
The following are the documents needed for obtaining an import license:
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 Drugs 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
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.
Post-Marketing Surveillance
The Post-Marketing Surveillance system in Vietnam is overseen by the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV).
Reporting of Adverse Drug Reactions (ADRs): Marketing Authorization (MA) holder is required to collaborate with the relevant drug manufacturer or importer, and distributor in tracking and reporting any cases of adverse drug reactions to the National Centre of Drug Information and Adverse Drug Reactions Monitoring.
With Vietnam emerging as one of the growing markets for pharmaceutical products, the DAV is coming up with a more stringent evaluation process each year. For more details on the regulatory process of the pharma products, get in touch the ArtiXio, a trusted consultant for assistance on regulatory needs.
FAQ’s
Q. What are some of the activities performed under the drug post marketing surveillance system in Vietnam?
A. 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. What is the ADR reporting system in Vietnam?
A. The National Drug Information and ADR Monitoring Centre (NDIADRMC) remains responsible for the collections and assessment of adverse drug reaction reports. It was established in 2009. Before NDIADRMC, all the spontaneous reports were collected by DAV.
Q. Does DAV alone review all the dossiers submitted to them?
A. 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).
References:
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