Vietnam’s pharmaceutical market has grown significantly in the last two years by 10% to US$5.2 billion and estimated to reach US$6.6 billion this year. This expanding market growth contributes to the country’s per capita spending of US$85 billion for pharmaceuticals today.

Reasons for pharmaceutical market growth

Several reasons contribute to the pharmaceutical market growth in Vietnam such as;

  • Favorable changes in the government policies and domestic regulations of imported drugs
  • Growing demand for quality healthcare with rising incomes in Vietnam 
  • Higher demand for affordable medicines 
  • Greater healthcare spending due to the continuous rise of the elderly population over the age of 60 years with changing disease pattern

Disease trends in Vietnam

  • Around 10% of Vietnamese are diabetes patients.
  • 116,000 Vietnamese die from cancer each year.
  • 73% of the total deaths account for noncommunicable diseases in Vietnam.
  • 30% of deaths nationwide account for cardiovascular disease.
  • In recent years, the top four causes of death were cerebrovascular .disease, coronary heart disease, Alzheimer’s disease, and lung cancer.

Opportunities for foreign generic drug manufacturers in Vietnam

  • Currently, domestic companies mostly focused on producing generic drugs as they lack research and development capacity for new drugs. However, even in the generic drug segment, Vietnam only meets about 40% of the domestic demand. 
  • In Vietnam, most national manufacturers can only produce medium-low quality generic drugs as they only have WHO-GMP standards.
  • Due to this, much of Vietnam’s spending is on pharmaceuticals. In 2017, the government spent around US$2.1 billion on imported pharmaceuticals to meet domestic product demands and only US$113 million on exported products. In 2018, the import turnover hit US$3 Billion.
  • In Vietnam, only 17 facilities have EU-GMP or PIC/S-GMP standards which significantly prevents the sales access to domestic hospitals as tier 1-2 generics required to be manufactured to EU-GMP or PIC/S-GMP standards. In 2019, domestic hospitals accounted for 75% of Vietnam’s pharmaceutical industry revenue around $4.9 billion.
  • Only Pymepharco and Imexpharm are capable of bidding into Tier 1 and 2 due to having EU-GMP standards.
  • The pharmaceutical market is also supported by programs designed to attract more foreign direct investment, as domestic companies look for partners to help transform production technology. 

Regulatory authority for Generic drugs in Vietnam?

Pharmaceutical products in Vietnam are under the management of the Ministry of Health (MOH). Drug Administration of Vietnam (DAV), one of the divisions under the Ministry of Health (MoH), has overall responsibility for the registration of pharmaceutical products in order to be marketed in Vietnam.

Who can apply for registration of Generic drugs in Vietnam?

The following entities are allowed to register pharmaceutical products in Vietnam

  • Domestic pharmaceutical manufacturers.
  • Foreign companies licensed to manufacture pharmaceuticals within Vietnam.
  • Domestic entities that are allowed to trade in pharmaceuticals.
  • Foreign entities having trading licenses.

The process to Register Generic drugs in Vietnam

The process to register generic drugs in Vietnam for the issuance of a marketing registration certificate involves the following steps

  • Step 1: Review your product details and understand the regulatory requirements applicable to your product.
  • Step 2: Application dossier submission.
  • Step 3: Evaluation of application dossier.
  • Step 4: respond to queries and obtain the product registration certificate.

Regulations and Process for Registering Generic Drug In Vietnam

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire.

The APAC market for generic drugs is forecasted to grow US 112.86 USD billion by 2025 from 75 billion in 2020 with a CAGR of 8.34% from 2020 to 2025. There is a growing demand for generic drugs in regions like Vietnam, Myanmar, Philippines, Laos, Brunei, etc.

The generic drug registration in these regions is simple but obtaining a clear regulatory process is difficult due to language barriers, lack of available information, etc.

To register your generic drug in Vietnam, you need to find answers to the following

  • Which is the regulatory authority in Vietnam?
  • How can foreign manufacturers register their generic drugs in Vietnam?
  • How about Bioequivalence studies?
  • Is the foreign bioequivalence data acceptable in Vietnam?
  • What are the requirements to register your generic drug in Vietnam?
  • How about the manufacturing site accreditation, or other such requirements?
  • What are the timelines and costs involved in the generic drug registration?
  • What is the post-approval process such as importation and license to import?

Get Details on Regulatory, Requirements, and Process for Registering Generic  Drugs in Vietnam.

Due to the increase in interest of the manufacturers to market their generic drugs in Vietnam, we are receiving an increased number of queries. We found that some of the queries were to understand the regulatory and process feasibility as the information available is not clear or incomplete.

Credevo has prepared a report by collecting the relevant information as per the current understanding and awareness of Credevo. Click on the blue button below to download the report.

What would you get by downloading this report?

  1. Details on the regulations, requirements, and process to register the generic drugs in Vietnam.
  2. Free assessment by Credevo to review your generic products and available data to know the applicable regulations.

Note: The details presented in the report are intended to help in creating awareness about the regulatory process and requirements for registering generic drugs in Vietnam. While the report can be considered as an informative resource, it is not being presented as legal guidance, a binding document, or any authoritative report. The information in this report was prepared based on relevant information from the public domain as of the date, however, the Vietnam regulations and requirements may change with time and it is advisable to refer to current regulations at any given time. It is recommended to confirm the specific details, requirements, and processes applicable to your specific products at a given time before initiating any process of registration.

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Step 1: Review your product details and understand the regulatory requirements applicable to your product

This involves collecting information on the different regulatory aspects with respect to generic product registration. For generic drugs, manufacturers need to prepare the application dossier complying with either ASEAN or ICH Common Technical Dossier.


This review process can be made easier with Credevo expert reviewing your product details. If you have downloaded the above referred ‘Report on the Market Approval Process of Generic Drugs in Vietnam’, just fill up the information below to receive a free assessment of your drug product details by Credevo experts to identify specific requirements apply for its registration.
Free assessment for the registration of generic drugs in Vietnam
Yes, I'd like to get my generic drug assessed to ascertain the requirements applicable for their market approval in Vietnam
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Step 2: Compile and submission of application dossier

The dossier must contain a cover page, the product information sheet, etc.  These documents must be arranged in order of the table contents with separation between the sections and the sections must be numbered for easy reference.

The following documents require separate sections enclosed with product information

  • Bioequivalence study report.
  • GMP-conformity assessment document regarding foreign manufacturers. 
Part 1: The administrative dossier
  • The documents in the case of application dossier of foreign drugs.
  • GMP inspection application is submitted by foreign manufacturers.
  • Inspection of documents about the manufacturing conditions.
Part 2: Contents of the Quality Documents includes

Report of bioavailability/bioequivalence study.

Step 3: Evaluation of the application dossier

From the date of receipt of the complete registration dossier, the Drug administration will review and send the dossier to expert evaluators. After evaluation, expert evaluators give their opinions to the Drug administration within a specified time.

Step 4: Respond to queries and receive the product registration

After the validation and assessment process, the DAV usually issues a written response if the dossier does not meet the requirements and state the reasons accordingly, and requests the applicant for supplementary documents or clarify issues regarding the application dossier.

The DAV then reviews the supplementation and explanation from the applicant and issue a marketing registration certificate of the drug within the specified time.

The dossier for which the Drug administration seeks opinions from Advisory Council, present them to the council and approves accordingly after the Council’s response.

Approval Timeline

Generic drug approval usually takes 14-22 months from the date of submission of the application dossier. Compared to the developed countries, the time taken to evaluate new and generic drug approvals is shorter in Vietnam. However,  the application submission process is rigorous.

Approval fees

The government Filing fee for marketing Authorization applications in Vietnam ranges between $220-300 USD which depends on the requirements whether the medicinal products have data confidentiality or bioequivalent dossier or clinical dossier requirements.


Do you have additional queries on registering your generic drugs in Vietnam?
Send us a message below. Credevo has an excellent team of experts on the ground to assist with the registration of generic drugs in Vietnam.
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References

  1. https://www.makrocare.com/WhitePapers/se-asian-regulatory-environment-p2.pdf 
  2. https://kenfoxlaw.com/requirements-of-new-pharma-registration-dossier-in-vietnam
  3. https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-vietnam/
  4. https://www.makrocare.com/WhitePapers/se-asian-regulatory-environment-p2.pdf
  5. https://ccs.ncgm.go.jp/050/060/010/idf-04-06/04_IIDF-6th-Presentation-TN-2019-06-07.pdf
  6. https://vanbanphapluat.co/decree-54-2017-nd-cp-guidelines-for-implementation-of-the-law-on-pharmacy
  7. https://vanbanphapluat.co/circular-no-08-2010-tt-byt-guiding-report-of-bioavailability-bioequivalence