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
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.
The Legal classification of drugs as per the Circular 20/2017/TT-BYT
Over-the-Counter (OTC) Drugs: These are medications that can be sold directly to consumers without the need for a prescription from a licensed healthcare professional. OTC drugs are considered safe for self-medication and are typically used to treat common health conditions such as common cold, fever.
Prescription Drugs: Prescription drugs are medications that can only be dispensed to patients with a valid prescription from a licensed healthcare professional, such as a doctor or a specialist. These drugs usually require more careful monitoring due to their potential side effects, interactions, or the need for specific medical supervision.
Traditional Herbal Medicines: Vietnam has a long tradition of using herbal remedies for various health conditions. Some traditional herbal medicines are considered pharmaceutical drugs and are subject to regulation by the Ministry of Health. These products are often used in parallel with modern pharmaceuticals.
Controlled Drugs: Controlled drugs are substances with a higher risk of abuse, dependence, or potential harm to public health. These drugs are tightly regulated, and their production, distribution, and prescription are subject to specific government controls. Controlled drugs may include certain opioids, stimulants, sedatives, and other psychoactive substances.
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.
The Registration process for pharmaceutical products.
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.
Drug Authorization fees
Drug Import and Distribution Requirements
Drug Registration: Before importing and distributing drugs in Vietnam, the drug product must be registered with MOH.
Local Representative: Foreign drug manufacturers and importers are required to appoint a local representative or a licensed distributor 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.
Important documents required to procure 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
Renewal of drugs
Timing for Renewal: The renewal process must be initiated before the expiry date of the drug registration.
Submission of Renewal Application: The marketing authorization holder (the drug manufacturer or its authorized representative) must submit a renewal application to the Drug Administration of Vietnam (DAV). The renewal application typically includes updated information about the drug, its safety profile, and any changes made since the initial registration.
Payment of Fees: Renewal of drug registration in Vietnam usually requires the payment of applicable renewal fees of approximately $130 USD.
Evaluation and Approval: The DAV will review the renewal application and supporting documents to assess the drug's continued safety, quality, and efficacy. If the drug meets all the required criteria and there are no safety concerns, the DAV will grant the renewal, allowing the drug to remain on the market.
Validity Period: Once the renewal is approved, the drug registration will be extended, typically for a period of five years from the initial registration's expiry date.
The Registration Process for Drugs approved in the EU/US is Streamlined
The approval by reputable regulatory authorities like the European Medicines Agency (EMA) in the EU or the U.S. Food and Drug Administration (FDA) in the US is often considered as an indicator of the drug's safety, quality, and efficacy. This approval can help in progressing the registration of drug products in Vietnam by providing the following benefits:
Expedited Review Process: In some cases, drug products that have already been approved by the EMA or FDA may be eligible for an expedited or streamlined review process in Vietnam. This can significantly reduce the time and resources required for registration.
Reference for Quality and Safety: The approval from EMA or FDA serves as a reference for the drug's quality and safety. It can demonstrate that the drug has undergone rigorous testing and evaluation, making it more likely to gain approval in Vietnam.
International Standards Recognition: The EU and the US have stringent regulatory standards for drug approval. Vietnamese regulatory authorities may take these approvals into consideration, as they align with international best practices, and can provide confidence in the drug's safety and efficacy.
Scientific Data Exchange: The scientific data submitted during the approval process in the EU or US can be shared with the Vietnamese regulatory authorities, potentially expediting the review process and reducing the need for redundant data submission.
Improved Credibility: Drug products approved in well-established regulatory jurisdictions like the EU or US may gain higher credibility and trust among healthcare professionals and consumers in Vietnam.
Possible Waiver of Certain Studies: In some cases, the Vietnamese regulatory authorities may consider waiving certain preclinical or clinical studies if the drug product has been extensively evaluated and approved in the EU or US.
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.
Safety Signal Detection: The pharmacovigilance centers in Vietnam continuously analyze the data collected from ADR reports to detect safety signals or potential new risks associated with specific drugs.
Risk Assessment and Communication: Upon detecting safety signals, the DAV assesses the risks and may issue safety communications or updates to healthcare professionals and the public to ensure appropriate use and management of the drug.
Collaboration with International Agencies: Vietnam collaborates with international organizations, such as the World Health Organization (WHO), to exchange safety information and benefit from global pharmacovigilance efforts.
Periodic Safety Update Reports (PSURs): Pharmaceutical companies are required to submit PSURs to the DAV periodically. These reports provide updates on the safety profile of their products based on real-world data and clinical experience.
Risk Management Plans (RMPs): In some cases, the DAV may require pharmaceutical companies to develop risk management plans to proactively address and mitigate potential safety concerns associated with their drugs.
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.
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