Clinical Research Regulation For Vietnam
Regulatory Authority
Regulatory Authority
Scope of Assessment
Regulatory Fees
Ethics Committee
Ethics Committee
Scope of Review
Ethics Committee Fees
Authorizing Body
Clinical Trial Lifecycle
Submission Process
Submission Content
Timeline of Review
Trial Initiation
Safety Reporting
Progress Reporting
Sponsorship
Definition of Sponsor
Trial Authorization
Insurance
Compensation
Quality, Data & Records Management
Site/Investigator Selection
Informed Consent
Documentation Requirements
Required Elements
Compensation Disclosure
Participant Rights
Special Circumstances/Emergencies
Vulnerable Populations
Children/Minors
Pregnant Women, Fetuses & Neonates
Prisoners
Mentally Impaired
Investigational Products
Definition of Investigational Product
Manufacturing & Import
IMP/IND Quality Requirements
Labeling & Packaging
Product Management
Specimens
Definition of Specimen
Specimen Import & Export
QUICK FACTS
Clinical trial application language Vietnamese or English
Regulatory authority & ethics committee review may be conducted at the same time Yes
Clinical trial registration required No
In-country sponsor presence/representation required No
Age of minors Under 16
Specimens export allowed Yes
Regulatory Authority > Regulatory Authority
Last content review/update: July 23, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 94
(2) (Regulation) Decision No. 4059/QD-BYT – Stipulating Functions, Duties, Powers and Organizational Structure of the Administration of Science, Technology and Training of the Ministry of Health (D-ASTTReg – English, unofficial translation) (Vietnamese) (Effective October 20, 2012)
Ministry of Health
Relevant Sections: Articles 1-3
(3) (Regulation) Decree No. 75/2017/ND-CP – Defining the Functions, Tasks, Powers and Organizational Structure of the Ministry of Health (DecreeMOH – Vietnamese) (June 20, 2017)
Socialist Republic of Vietnam
Relevant Sections: Articles 1-3
(4) (Regulation) Circular No. 08/2014/TT-BYT - Rules of Operation Supporting Research Clinical Trials in Vietnam (C-ClinTrialOps – English, unofficial translation) (Vietnamese) (Effective May 1, 2014)
Ministry of Health
Relevant Sections: Articles 9-11 and Forms 1 and 2
(5) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 1-2, 19, 21-22, and 29
Summary

Overview

As per the C-ClinDrugTrialGCP, PharmLaw, DecreeMOH, and D-ASTTReg, Vietnam’s Ministry of Health (MOH) is the regulatory authority responsible for clinical trial approvals, registration, oversight, and inspections. The MOH grants permission for clinical trials to be conducted in Vietnam.

As indicated in DecreeMOH, the MOH is a governmental agency whose mission is to oversee all aspects of public health care management and protection for the Vietnamese population. With regard to pharmaceuticals, the MOH’s activities include, but are not limited to, formulating and promulgating legal documents, regulations, and national standards; granting and withdrawing pharmaceutical practice certificates; issuing certificates of eligibility, registration permits, medicine import/export permits, and certificates of good manufacturing practice (GMP).

In addition, the C-ClinDrugTrialGCP and D-ASTTReg state that the MOH’s Administration of Science, Technology and Training (ASTT) is responsible for managing the clinical trial review process. As per the C-ClinTrialOps, the MOH’s ASTT is also responsible for registering contract research organizations (CROs) that support clinical studies and provide other research services. (See the C-ClinTrialOps for detailed dossier registration requirements and applicable forms.)

Please note: Vietnam is party to the Nagoya Protocol on Access and Benefit-sharing (VNM-2), which may have implications for studies of investigational products developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see VNM-6.

Contact Information

Ministry of Health
Administration of Science, Technology and Training
138B Giang Vo St.
Ba Dinh District
Hanoi City, Vietnam

Phone: 04.33846688
Fax: 04.32373236
Email: cuck2dt@moh.gov.vn

Additional Resources
(1) (Document) Nagoya Protocol on Access and Benefit-sharing (VNM-2) (2011)
Convention on Biological Diversity, United Nations
(2) (Webpage) Country Profile: Vietnam (VNM-6) (Current as of December 15, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
Regulatory Authority > Scope of Assessment
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Articles 89 and 94
(2) (Regulation) Circular No. 03/2012/TT-BYT – Guidelines for Clinical Trials on Drugs (Partially repealed) (C-ClinDrugTrial – English, unofficial translation) (Vietnamese) (Effective March 20, 2012)
Ministry of Health
Relevant Sections: Article 5
(3) (Regulation) Circular No. 21/2018/TT-BYT – Regulations on the Registration of Traditional Medicines and Pharmaceuticals (C-TradMedicine – Vietnamese) (Effective October 28, 2018)
Ministry of Health
Relevant Sections: Articles 1 and 7
(4) (Regulation) Circular No. 32/2018/TT-BYT – Regulations on Registration of Drugs and Medicinal Materials (C-DrugRegistration – Vietnamese) (Effective September 1, 2019)
Ministry of Health
Relevant Sections: Articles 2, 13, 18, and 44
(5) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 3 and 15
(6) (Regulation) Decision No. 4059/QD-BYT – Stipulating Functions, Duties, Powers and Organizational Structure of the Administration of Science, Technology and Training of the Ministry of Health (D-ASTTReg – English, unofficial translation) (Vietnamese) (Effective October 20, 2012)
Ministry of Health
Relevant Sections: Articles 1-3
(7) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 1 and 8, and Form 1)
(8) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 19, 21-22, and 29
Summary

Overview

In accordance with the C-ClinDrugTrialGCP, PharmLaw, and D-ASTTReg, Vietnam’s Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process for registered and unregistered investigational products (IPs). The ASTT is responsible for reviewing all clinical study documents, and per the C-ClinDrugTrialGCP, PharmLaw, C-BioequivTrial, and the C-ECReg, the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research proposal.

The C-ECReg further indicates that an institutional level EC, called a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), reviews the ethical and scientific aspects of the research before submitting the research documents to the NECBR for approval. For institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR or the CEBRGL of another institution with appropriate expertise.

According to the C-ClinDrugTrialGCP, the ASTT’s review is conducted in parallel with the NECBR review. However, the ASTT review will only be finalized once the NECBR approval is obtained, and then the entire study approval dossier will be sent to the Minister of Health for final approval.

As per the C-ClinDrugTrial and PharmLaw, the scope of the MOH’s assessment includes all clinical trials (Phases I-IV) for the following:

  • Drugs that contain a new active ingredient, or products with a new combination of marketed ingredients
  • Newly developed biologics or biologics with a new combination of marketed ingredients
  • Newly developed vaccines that are manufactured and used for the first time
  • Drugs, biologics, and vaccines which have been legally marketed for a period of less than five (5) years in the country of origin (or a country of reference if provided for under international treaties to which Vietnam is a signatory)
  • Drugs, biologics, and vaccines for which a clinical trial has been conducted, but have not met the MOH’s or internationally recognized good clinical practice (GCP) requirements

In addition, per the C-TradMedicine, the MOH also reviews and approves traditional medicines to be used in clinical trials (Phases I-IV) unless deemed exempt by the agency. The category of traditional medicine includes drugs developed from a provincial-level scientific research project or higher, drugs that were granted a certificate, or drugs used for treatment at health establishments at a provincial level or higher for 10 years or more and for 200 or more patients. The drugs must also have been approved by a Science and Technology Council or EC specialized in traditional medicine as effective and safe to treat traditional medical diseases. Traditional medicines also include ancient methods.

As delineated in the C-ClinDrugTrialGCP, the MOH’s ASTT is responsible for reviewing the submitted clinical trial registration and study approval dossiers for completeness. As part of its study approval dossier review, the MOH also organizes the NECBR meeting.

Pursuant to the C-DrugRegistration, an Advisory Council created by the MOH issues registration papers for drug and medicinal ingredient circulation. The Advisory Council consists of members who are experts with appropriate professional qualifications and experience to ensure the ability to appraise dossiers, to critique experts' opinions and recommendations of the MOH’s Drug Administration of Vietnam (DAV), and advise the Minister of Health on issues related to pharmaceutical legislation, quality, safety, and efficacy records of drugs and medicinal ingredients. Based on the opinion of the Advisory Council, the Minister of Health may exempt certain new drugs, vaccines, and biological products from one (1) or more stages of a clinical trial (including clinical data exemption or reduction). Registration certificates may be issued with the clinical trial stage exemption in the following cases:

  • Medicines that meet urgent needs for national defense and security, epidemic prevention and control, and overcoming the consequences of natural calamities and catastrophes in which other drugs are not yet available on the market
  • The drug has been licensed for circulation by at least two (2) of the reference regulatory agencies specified in C-DrugRegistration, or has been licensed for circulation pursuant to exemption regulations by the US Food and Drug Administration (FDA) or by the European Medicines Agency (EMA). The reference regulatory agencies specified in C-DrugRegistration include regulators in the US, Japan, France, Germany, Sweden, the United Kingdom, Switzerland, Australia, Canada, Belgium, Austria, Ireland, Denmark, and the Netherlands, as well as the EMA
  • Medicines used to treat rare and fatal diseases
  • Vaccines and biological products manufactured in Vietnam in the form of technology transfer in one (1), several, or all stages of the finished product manufacturing process (for vaccines and biological products with clinical data complying with the provisions of C-DrugRegistration prior to the technology transfer)

For additional details, see C-DrugRegistration.

Clinical Trial Review Process

The C-ClinDrugTrialGCP indicates that as the first step in the review process, the ASTT requires the sponsor to submit a registration dossier, which includes the registration application form and a summary of the Investigator’s Brochure (IB) (also referred to as the research product profile in Vietnam). The summary includes general information about the IPs (name, ingredients, indications, physical properties, chemistry, preparation and other relevant information); pre-clinical research materials; and clinical trial study documents from previous stages. (Note: The C-ClinDrugTrialGCP and C-BioequivTrial also refer to the sponsor as “organizations and individuals with clinical reagents” or “donor”.)

The C-ClinDrugTrialGCP further states that upon receipt of the appropriate files, the ASTT will check the validity of the registration dossier within five (5) working days. If any issues are identified, the sponsor must coordinate with the ASTT to complete the dossier within 60 days. The director of the ASTT will issue a written decision within five (5) working days of receiving a complete and valid dossier.

As per the C-ClinDrugTrialGCP, research institutions must then submit dossiers requesting clinical drug trial approval directly or by post to the ASTT. The ASTT checks the validity of the approval request dossier within five (5) working days. If any issues are identified, the establishment must coordinate with the ASTT to finalize the dossier within 60 days.

The C-ClinDrugTrialGCP requires that within 25 days of receiving a complete and valid approval request dossier, the MOH will produce a written appraisal of the clinical drug research proposal and organize a meeting of the NECBR. Within five (5) working days from the date of the NECBR’s appraisal report, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

If the research proposal is not approved or needs to be corrected, the ASTT shall notify the establishment and state the reason. If any issues are identified, the establishment must coordinate with the ASTT to complete the dossier within 90 days from the date of the notice. Within five (5) working days after receiving the completed research proposal in accordance with the written notice, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

(See the Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed submission requirements.)

Additional Resources
No additional resources
Regulatory Authority > Regulatory Fees
Last content review/update: May 13, 2020
Requirements
No applicable regulatory requirements
Summary

Overview

According to an in-country subject matter expert, the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) is in the process of developing a guideline on fees required to submit a clinical trial application for authorization.

Additional Resources
No additional resources
Ethics Committee > Ethics Committee
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 5-9, 13, 15, 18, and 21
(3) (Regulation) Decision No. 111/QD-BYT – On the Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at the Grass-Root Level (D-CEBRGLReg – English, unofficial translation) (Vietnamese) (January 11, 2013)
Ministry of Health
Relevant Sections: Articles 3-4, and Chapters II-III
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: 19 and 22
(5) (Regulation) Decision No. 1122/QD-BYT – On the Establishment of the Ethics Committee in National Biomedical Research of the Ministry of Health, Period 2018-2023 (D-NECBR2018 - Vietnamese) (February 2, 2018)
Ministry of Health
Relevant Sections: Articles 2-4 and Attachment (2018-2023 Membership List)
Summary

Overview

As per the C-ECReg, the C-ClinDrugTrialGCP, and PharmLaw, Vietnam requires institutional and national level ethics committee (EC) approval for clinical trials. According to an in-country subject matter expert, institutional level EC approval is performed by an EC that is registered as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) with the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT). D-NECBR2018 and PharmLaw state that national level EC approval is conducted by the MOH’s National Ethics Committee in Biomedical Research (NECBR).

According to C-ECReg and an in-country subject matter expert, if the study is not a clinical trial, applicants are only required to obtain approval from a CEBRGL.

EC Composition

The C-ECReg details general EC requirements applicable to both the CEBRGLs and the NECBR, as well as specific requirements for each type of EC.

Per the C-ECReg, EC membership should include the following:

  • Members with a professional degree in the health sector related to the common research areas assessed by the EC, including at least one (1) person independent from the organization that establishes the EC
  • Clinical doctors
  • Members with legal expertise or knowledge of ethical principles in biomedical research, with a university degree or higher
  • Members with no expertise in the health sector
  • Members under 40 years of age, members from 40 years old to under 50 years old, and members aged 50 or older
  • Male and female members (neither gender may be less than 20% of the total membership)

In addition, EC members must have the necessary experience, knowledge, skills, and ability to perform his/her duties in order to validate the science and protect the interests of research participants. Members with expertise in the health sector must have at least five (5) years of experience working in the field of research assessed by the EC. All members must also have time to participate in and perform the duties of the EC, and keep confidential any information related to the research, opinions discussed during the meeting, commercial secrets of individuals and organizations participating in the study, and personal information about the research participant. Members must also receive training and certification from the MOH or MOH-accredited organizations in Good Clinical Practice (GCP) and the EC’s standard operating procedures (SOPs).

NECBR Composition

The C-ECReg requires the NECBR to have at least nine (9) official members, including one (1) chair, three (3) vice-chairs, and other official members, including professional and administrative secretaries. The NECBR also includes data monitoring and other subcommittees as needed. The ASTT and the MOH act as standing members of the office of the NECBR.

As per D-NECBR2018, for the 2018-2023 term, the NECBR is comprised of an MOH Standing Office, a Standing Committee, five (5) specialized subcommittees (Pharmaceuticals, Traditional Medicines, Vaccines and Medical Biologicals, Medical Equipment, and New Technology), a professional secretary team, an administrative secretary team, and an advisory team. The NECBR is headed by a chair, a standing vice-chair, and two (2) other vice-chairs. Each subcommittee consists of five (5) to seven (7) members.

The C-ECReg requires that the chair and vice-chairs have at least 15 years of experience working in the field of research evaluated by the EC, a good reputation, and the capacity to independently manage and run the EC. The chair and vice-chairs must also be fair and impartial, and not be pressured by the research institution, investigators, and other agencies, organizations, and individuals. An individual cannot be appointed as the chair of the EC for more than two (2) consecutive terms.

According to the C-ECReg, the NECBR should have no more than three (3) professional secretaries, and two (2) administrative secretaries at most. However, D-NECBR2018 indicates that for the 2018-2023 term, there are four (4) professional secretaries.

The C-ECReg states that professional and administrative secretaries must be honest, objective, and university-educated. Professional secretaries must have knowledge about scientific and technological management, scientific research, and ethics in biomedical research, while administrative secretaries must have administrative, clerical, and archival skills.

See the C-ECReg for additional NECBR membership criteria. See D-NECBR2018 for the list of 2018-2023 NECBR term members.

CEBRGL Composition

As explained in the C-ECReg and D-CEBRGLReg, institutional ECs, known as CEBRGLs, should consist of at least five (5) members. The C-ECReg states that a CEBRGL consists of one (1) chair, one (1) to two (2) vice-chairs, a standing division, and specialized subcommittees (if necessary).

D-CEBRGLReg further indicates that CEBRGLs may have at most 11 members. All members must be honest, objective, and have biomedical research ethics knowledge and expertise. The chair and vice-chair should be prestigious scientists.

The C-ECReg requires that the chair and vice-chairs have at least 15 years of experience working in the field of research evaluated by the EC, a good reputation, and the capacity to independently manage and run the EC. The chair and vice-chairs must also be fair and impartial, and not be pressured by the research institution, investigators, and other agencies, organizations, and individuals. An individual cannot be appointed as the chair of the EC for more than two (2) consecutive terms.

According to the C-ECReg, a CEBRGL should have no more than two (2) professional secretaries and no more than two (2) administrative secretaries. Professional and administrative secretaries must be honest, objective, and university-educated. Furthermore, professional secretaries must have knowledge about scientific and technological management, scientific research, and ethics in biomedical research, while administrative secretaries must have administrative, clerical, and archival skills.

According to D-CEBRGLReg, a secretariat based in the host institution’s Science Research Management Office should assist the CEBRGL with application processing and other administrative tasks.

See the C-ECReg and D-CEBRGLReg for additional CEBRGL membership criteria.

Terms of Reference, Review Procedures, and Meeting Schedule

According to the C-ECReg, both CEBRGLs and the NECBR have five (5) year terms. However, the D-CEBRGLReg indicates that CEBRGLs have three (3) to five (5) year terms, as specified in the EC’s establishment decision.

The C-ECReg also stipulates that the EC must be established or reorganized at the end of the term. The EC for the next consecutive term must include at least 25% new members.

As stated in the C-ECReg, EC activities are non-profit. The EC must fully apply the ethical principles prescribed in C-ECReg and relevant legal documents, and comply with ethical guidelines of international organizations. The ethical guidelines used by the EC should be clearly stated and disseminated to investigators.

In addition, ECs function on the principles of collectivity, democracy, and independence when evaluating research proposals and making decisions. If necessary, ECs may invite an independent consultant to provide a professional opinion to the EC. ECs should also facilitate the coordination of and/or reference the appraisal results of other domestic or foreign ECs.

According to the C-ECReg, the EC’s decision for a research proposal should be based on the consensus of the EC members and must be recorded in the EC’s meeting minutes. In case it is difficult to reach a consensus, the EC’s chair has the right to decide to immediately conduct voting, or request that the principal investigator supplement the research dossier for the EC to consider and vote on during the next EC meeting. Research is approved only when there are less than two (2) disapproval votes out of the total number of valid votes.

In addition, ECs must conduct periodic assessments of ongoing studies within a time period that is consistent with the level of risk for study participants, but at least once a year on or before the date the EC approved the research protocol. The conclusion of the periodic assessment results should state that the EC’s previous decisions are still valid, or have been changed, suspended, or revoked.

The C-ECReg requires that EC members be trained prior to appointment and provided with updated and supplementary training in the ethical and scientific aspects of biomedical research. The head of the organization that establishes the EC is responsible for assigning a unit to manage scientific research activities to develop and deploy training plans for EC members. The updated and supplementary training must be conducted at least once every two (2) years. For more information on training requirements for EC members, see C-ECReg.

As set forth in D-CEBRGLReg, the CEBRGLs should operate within written SOPs to conduct their reviews. The chair oversees the meetings, makes conclusions, and reports this information to the institutional head. Voting members must have no conflict of interest with the research. The CEBRGL members must review research documentation and prepare comments for the secretary prior to the meeting. Most CEBRGLs do not meet regularly but instead meet upon request for review and on the availability of the majority of its members. The CEBRGLs should also refer to the NECBR’s SOPs to develop their own SOPs. See D-CEBRGLReg for detailed CEBRGL review procedures.

Additional Resources
No additional resources
Ethics Committee > Scope of Review
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Articles 90 and 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 3, 15-20, and 24
(3) (Regulation) Decision No. 111/QD-BYT – On the Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at the Grass-Root Level (D-CEBRGLReg – English, unofficial translation) (Vietnamese) (January 11, 2013)
Ministry of Health
Relevant Sections: Articles 5 and 8-9
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 2 and 22
(5) (Regulation) Decision No. 1122/QD-BYT – On the Establishment of the Ethics Committee in National Biomedical Research of the Ministry of Health, Period 2018-2023 (D-NECBR2018 - Vietnamese) (February 2, 2018)
Ministry of Health
Relevant Sections: Article 2
Summary

Overview

According to the C-ECReg, D-NECBR2018, D-CEBRGLReg, the C-ClinDrugTrialGCP, and PharmLaw, the primary scope of information assessed by ethics committees (ECs) relate to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial.

As per the C-ECReg, D-CEBRGLReg, and PharmLaw, ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable or those with limited or no legal capacity. The C-ECReg further indicates that when considering research related to vulnerable groups, representatives of the research participants or experts with knowledge and experience working with the groups must participate in the EC meeting. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; and Pregnant Women, Fetuses, and Neonates for additional information about these populations).

The C-ECReg and D-CEBRGLReg also state that the institutional ECs, known as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs), and the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR) are responsible for ensuring independent, timely, and competent reviews of all ethical aspects of the clinical trial protocol. They must act in the interests of the potential research participants and the communities involved by evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality and privacy safeguards. See the C-ECReg and D-CEBRGLReg for detailed ethical review guidelines.

The C-ECReg indicates that when ECs conduct research record evaluations, ongoing research supervision, and research results evaluations, they should appraise the following:

  • Research design and conduct
  • Potential risks and benefits
  • Selection of research populations and participants’ selection and protection
  • Financial benefits and financial costs related to research participants
  • Protecting the research participants’ privacy and confidentiality
  • The process of providing information and obtaining participants’ written consent to participate in research
  • Impact of research on the participants’ community
  • Researcher capacity and research goal

Role in Clinical Trial Approval Process

As delineated in the C-ClinDrugTrialGCP and PharmLaw, the MOH’s Administration of Science, Technology and Training (ASTT) is responsible for reviewing the clinical trial registration and study approval dossier for completeness. In addition to MOH approval, the MOH’s national level EC, the NECBR, is responsible for approving the research proposal. In addition, as indicated in the C-ClinDrugTrialGCP and the C-ECReg, the applicant must obtain institutional EC (CEBRGL) approval, followed by NECBR review and approval. The C-ECReg further indicates that for institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR, or the CEBRGL of another institution with appropriate expertise.

According to an in-country subject matter expert, the CEBRGL review and approval process generally takes one (1) week. However, most CEBRGLs do not meet regularly. Instead, meetings are scheduled upon request and are based on the availability of the majority of its members.

As per the C-ClinDrugTrialGCP, the ASTT review process is conducted in parallel with the NECBR’s review. However, per the C-ClinDrugTrialGCP and PharmLaw, the ASTT’s review will only be finalized once the NECBR’s approval is obtained. At that point, the ASTT will send the entire study approval application to the Minister of Health for final approval.

The C-ECReg indicates that ECs may assess a research dossier or application under an expedited process if:

  • The research involves minimal risk
  • The research documents have been previously reviewed by an EC
  • The research documents have been reviewed and approved by an EC of the same level
  • It is a periodic report on implementation of research that has already been approved
  • It is an application for amendment and supplementation of a research protocol that has already been approved
  • It is reporting adverse events occurring in research that has already been approved
  • It is reporting violations of an approved research protocol

According to the C-ECReg, research dossiers are reviewed under the EC’s full process if they do not qualify for expedited review as stipulated above, or if the appraiser requests that the dossier be examined according to the full process.

Under both the expedited and full review processes, within 30 days from the date of receipt of a complete and valid dossier, the EC must organize an examination of the dossier and notify the applicant of the EC’s decision. While both processes may take up to 30 days, the expedited review is streamlined with fewer reviewers, as explained below. The EC’s decision under the full review process is legally valid when at least five (5) members (including at least one (1) member with appropriate expertise in the health sector, one (1) member with no expertise in the health sector, and one (1) independent member), including members of both sexes, are present at the EC’s meeting and vote in the decision. The meeting must also have been convened by the EC’s chair or vice-chair (if authorized), and have meeting minutes. The EC's expedited review process decision is legally valid when at least two (2) members of the EC have reviewed and evaluated the dossier.

Within five (5) working days from the date that the research dossier appraisal results are available, the EC must send a written notification to the leading research institution and principal investigator, and must publish the appraisal results on a bulletin board or on the website of the EC or the organization that established the EC. The EC may approve, conditionally approve, or decide not to approve a research dossier, and the written notifications must be issued accordingly.

See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission process requirements.)

Additional Resources
No additional resources
Ethics Committee > Ethics Committee Fees
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 12 and 22
Summary

Overview

As stated in the C-ECReg, ethics committees (ECs) should indicate the fee structure (if any) required to assess a proposed study. Fee requirements should be included in the written instructions provided to investigators for submitting research dossiers for evaluation. The head of the organization that establishes the EC is responsible for allocating sufficient resources for the EC to perform its duties effectively.

According to an in-country subject matter expert, the Ministry of Health (MOH)’s National Ethics Committee in Biomedical Research (NECBR) charges a fee to review clinical trial documentation. The current NECBR fees are $1,000-$2,000 USD.

Additional Resources
No additional resources
Ethics Committee > Authorizing Body
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 27
Summary

Overview

According to C-ECReg and an in-country subject matter expert, Vietnam’s Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) is responsible for registering the institutional level ethics committees (ECs). The institutional ECs are registered as Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs). The C-ECReg further indicates that the ASTT is responsible for suspension, or proposing suspension to a competent authority, of an EC’s operation in case it is found that the EC violates the provisions of C-ECReg, affecting the protection of rights, safety, and health of research participants.

Additional Resources
No additional resources
Clinical Trial Lifecycle > Submission Process
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 15 and 22
(3) (Regulation) Decision No. 4059/QD-BYT – Stipulating Functions, Duties, Powers and Organizational Structure of the Administration of Science, Technology and Training of the Ministry of Health (D-ASTTReg – English, unofficial translation) (Vietnamese) (Effective October 20, 2012)
Ministry of Health
Relevant Sections: Articles 1-3
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 19-22 and Appendix III (Forms No. 6 and 7)
Summary

Overview

In accordance with the C-ClinDrugTrialGCP, PharmLaw, and D-ASTTReg, Vietnam requires the sponsor to obtain clinical trial authorization from the Ministry of Health (MOH). The Administration of Science, Technology and Training (ASTT) is the department within the MOH that manages the clinical trial review process. As delineated in the C-ClinDrugTrialGCP and PharmLaw, the ASTT is responsible for reviewing the clinical trial registration and study approval dossier for completeness. In addition to MOH approval, the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research proposal. (Note: The C-ClinDrugTrialGCP also refers to the sponsor as “organizations and individuals with clinical reagents” or “donor” throughout the document.)

As per the C-ClinDrugTrialGCP, the ASTT review and the MOH’s approval process is conducted in parallel with the NECBR review. However, per the C-ClinDrugTrialGCP and PharmLaw, the ASTT review will only be finalized once the NECBR approval is obtained, and then the entire study approval dossier will be sent to the Minister of Health for final approval. As indicated in the C-ClinDrugTrialGCP and the C-ECReg, the applicant must obtain institutional EC approval prior to NECBR review and approval. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

According to C-ECReg, ECs issue guidelines for research evaluation submissions, providing information and regulatory forms for investigators. See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed information on the EC guidelines.

Delivery Address for Clinical Trial Application

Ministry of Health
Administration of Science, Technology and Training
138B Giang Vo St.
Ba Dinh District
Hanoi City, Vietnam

Phone: 04.33846688
Fax: 04.32373236
Email:
cuck2dt@moh.gov.vn

Assembly and Number of Copies

As per the C-ClinDrugTrialGCP, the sponsor must submit directly or via post, one (1) copy of the clinical trial registration dossier signed by the sponsor’s representative(s) to the MOH’s ASTT. Further, research institutions must submit one (1) copy of the study approval dossier, signed by the principal investigator (PI) and the head of the testing facility, directly or via post to the ASTT (see Appendix III of the C-ClinDrugTrialGCP for the registration form and the forms that comprise the study approval dossier).

Clinical Trial Application Language Requirements

As delineated in the C-ClinDrugTrialGCP, the clinical trial application and accompanying material must be provided in Vietnamese or English. If the document is not available in Vietnamese or English, a notarized translation of the document must be provided in Vietnamese or English. The C-ClinDrugTrialGCP also indicates that the summary of the Investigator’s Brochure (IB) (also referred to as the research product profile in Vietnam) to be submitted to the MOH with the registration application should be in Vietnamese or English, with a summary in Vietnamese.

Additional Resources
No additional resources
Clinical Trial Lifecycle > Submission Content
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 3, 15, and 22-23
(3) (Regulation) Decision No. 4059/QD-BYT – Stipulating Functions, Duties, Powers and Organizational Structure of the Administration of Science, Technology and Training of the Ministry of Health (D-ASTTReg – English, unofficial translation) (Vietnamese) (Effective October 20, 2012)
Ministry of Health
Relevant Sections: Articles 1-3
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 19 and 21-22, and Appendix III (Forms No. 6, 7, and 8)
Summary

Overview

As per the C-ClinDrugTrialGCP, PharmLaw, D-ASTTReg, Vietnam requires that clinical trial authorization be obtained from the Ministry of Health (MOH). The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. According to the C-ClinDrugTrialGCP and PharmLaw, the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers for completeness.

Per the C-ClinDrugTrialGCP, the C-ECReg, and PharmLaw, the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research proposal. The MOH schedules the NECBR review, which also occurs in parallel with the ASTT review. Per the C-ClinDrugTrialGCP, once the ASTT has completed its review and the NECBR has reviewed and approved the research proposal, the Minister of Health must give final approval to the entire study approval dossier.

In addition, as indicated in the C-ClinDrugTrialGCP and the C-ECReg, the applicant must obtain institutional EC approval prior to NECBR review and approval. According to an in-country subject matter expert, institutional level EC approval is performed by an EC that is registered as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) with the MOH’s ASTT. The C-ECReg further indicates that for institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR, or the CEBRGL of another institution with appropriate expertise. For additional information on the institutional EC (CEBRGL) and NECBR review processes, please refer to the Ethics Committee topic.

MOH ASTT Requirements

As per the C-ClinDrugTrialGCP, the following documentation must be submitted to the MOH’s ASTT for clinical trial registration dossiers:

  • Clinical trial registration application form signed by a representative of the sponsor (See Form No. 6 in Appendix III of C-ClinDrugTrialGCP)
  • Summary of the Investigator’s Brochure (IB) (also referred to as the research product profile in Vietnam) including general information about the clinical reagent (name, ingredients, indications, physical properties, chemistry, preparation, and other relevant information), pre-clinical research materials, and clinical trial study documents from previous stages

For clinical trial study approval dossiers, the following documentation must be submitted to the MOH’s ASTT:

  • Clinical trial approval application form signed by the principal investigator (PI) and the head of the research institution (See Form No. 7 in Appendix III of C-ClinDrugTrialGCP)
  • Full IB, including proof of compliance with Good Laboratory Practices (GLPs) for research institutions or proof of compliance with Good Manufacturing Practices (GMPs) (also referred to as good medicine production standards in Vietnam) for drug manufacturers, and proof of compliance with quality testing requirements from national inspection agencies or ex-warehousing certificates for vaccine or biological batches (Refer to Investigational Products topic, IMP/IND Quality Requirements subtopic for detailed IB requirements)
  • A copy of the written approval for clinical trial registration from the MOH’s ASTT
  • For phase IV clinical trials, a certified or notarized copy of the written request for phase IV clinical drug testing from the respective regulatory authorities
  • A certified or notarized copy of the research institution’s certificate of eligibility for pharmaceutical business
  • Certification of participation by all study sites for multicenter research studies in Vietnam
  • A certified or notarized copy of the approval from the People’s Provincial Committee (for community-based studies)
  • Contract/agreement between the sponsor and the host institution; and contract/agreement between sponsor and the contract research organization (CRO), if applicable
  • Explanation of study protocol (See Form No. 8 in Appendix III of C-ClinDrugTrialGCP)
  • Case report form (CRF)
  • PI’s Curriculum Vitae (CV) and a copy of the Good Clinical Practice (GCP) certificate issued by the MOH or an institution recognized by the MOH
  • Informed Consent Form (ICF) (See Form No. 9 in Appendix III of C-ClinDrugTrialGCP) (See also Informed Consent topic, Required Elements subtopic for additional information)
  • CEBRGL appraisal report
  • IP labeling

See the C-ClinDrugTrialGCP for detailed requirements.

EC Requirements

The C-ECReg indicates that both the institutional level ECs (CEBRGLs) and the national EC (NECBR) should issue guidelines for research evaluation submissions, providing information and regulatory forms for investigators. The guidelines include information on the following:

  • Name and address of the secretary, employee, or member of the EC receiving the application file, or address of the website (if any)
  • List of all written material in record
  • Specifications of the documents
  • Language of the document in the record
  • Number of copies to be submitted
  • Application deadline compared to appraisal date
  • Recording and notification processes for invalid documents
  • Estimated time for post-assessment decision announcement
  • The timeframe that should be followed if the EC requires the applicant to provide additional information or documents
  • Evaluation fee of research records (if any)
  • Procedures for requesting EC approval of an amendment of the outline or related documents
  • Specification of materials for selection, information, and consent to participate in the study

According to C-ECReg, the documents that ECs must review when evaluating a research proposal include:

  • Signed and dated application, including signatures of co-applicant and representative of the relevant organization
  • Research protocol (with version number and date), with documents and appendices (if any)
  • A summary of the study in simple and understandable language
  • Description of ethical considerations relevant to the study (may be included in the protocol); measures that will be taken to protect participant privacy and data confidentiality; protective care for participants; compensation to be provided to participants; and insurance package for participants (if applicable) (See Informed Consent topic, Required Elements, Compensation Disclosure, and Participant Rights subtopics for detailed information)
  • IB
  • Study data collection forms (with version numbers and dates)
  • Forms, documents, and advertisements used in participant selection process
  • ICF (with version number and date) for participants that are 18 years or older and have full civil capacity to give consent
  • ICF (with version number and date) for participants and their parents and/or legal guardian(s), if the participant is 16 years old to under 18 years old
  • ICF (with version number and date) for parents and/or legal guardian(s), if the participant is under 16 years old
  • Assent form (with version number and date) for participants who do not have the capacity to give legal consent, including children from 12 years old to under 16 years old, a person with inadequate civil act capacity, or a patient in a limited cognitive condition
  • Description of participant selection and ICF collection processes
  • Procedures for monitoring, evaluating, and managing adverse events (AEs) (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional AE/SAE information)
  • All previous decisions of other ECs or regulatory authorities regarding the proposed study (including decisions and reasons for objecting or proposing amendments to the previous protocol)
  • Documents demonstrating that the research institution has agreed to allow the study after the regulatory authority’s approval (if the study is conducted outside the organization that established the EC)
  • Investigators' commitment to agree to comply with the ethical guidelines
  • The PI’s current scientific background and qualifications related to the relevant research

See C-ECReg for additional information on submission requirements for research protocol re-evaluation or amendments, as well as for appraisal applications for periodic reports, adverse event reports, protocol violation reports, and research result reports.

Clinical Protocol

As per the C-ClinDrugTrialGCP, the MOH requires the following elements to be included in a protocol submission:

  • Title
  • Protocol code
  • Duration
  • Management level (state/ministry/institution/province)
  • PI/co-investigator(s) names and contact information
  • Funding
  • Phase requested
  • Institution to conduct research
  • Sponsor and contact information
  • Situation of domestic and foreign research
  • Objectives
  • Methodology (including trial design, random selection method, and standard operating procedures (SOPs) for each research technique)
  • Participant selection/withdrawal
  • Participant treatment
  • Adverse event reporting requirements (See Clinical Trial Lifecycle topic, Safety Reporting subtopic for additional information)
  • Laboratory test methods
  • Ethical considerations
  • Inspection and monitoring
  • Post study medical care
  • Study team training
  • International cooperation
  • Implementation progress
  • Format of the expected results
  • Activities of coordinating organizations

See Appendix III in the C-ClinDrugTrialGCP for a copy of the full form.

Additional Resources
No additional resources
Clinical Trial Lifecycle > Timeline of Review
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 3, 15, 22, 20, and 24
(3) (Regulation) Decision No. 4059/QD-BYT – Stipulating Functions, Duties, Powers and Organizational Structure of the Administration of Science, Technology and Training of the Ministry of Health (D-ASTTReg – English, unofficial translation) (Vietnamese) (Effective October 20, 2012)
Ministry of Health
Relevant Sections: Articles 1-3
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 19 and 21-22
Summary

Overview

As stated in the C-ClinDrugTrialGCP, PharmLaw, and D-ASTTReg, Vietnam requires that clinical trial authorization be obtained from the Ministry of Health (MOH). The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. According to the C-ClinDrugTrialGCP and PharmLaw, the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers for completeness. Per the C-ClinDrugTrialGCP, the C-ECReg, and PharmLaw, the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research proposal. As indicated in the C-ClinDrugTrialGCP and the C-ECReg, the applicant must obtain institutional EC approval prior to NECBR approval.

According to an in-country subject matter expert, institutional level EC approval is performed by an EC that is registered as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) with the MOH’s ASTT. The C-ECReg  indicates that for institutions conducting research that do not have a CEBRGL, the review and evaluation of the research is performed by the NECBR, or the CEBRGL of another institution with appropriate expertise.

As per the C-ClinDrugTrialGCP, the MOH’s ASTT review process is conducted in parallel with NECBR review. However, per the C-ClinDrugTrialGCP and PharmLaw, the ASTT review will only be finalized once the NECBR approval is obtained, and then the entire study approval dossier will be sent to the Minister of Health for final approval. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

MOH Approval

Clinical Trial Application Submission

As delineated in the C-ClinDrugTrialGCP, the first step in the review process is for the sponsor to submit registration files to the ASTT. This documentation includes the registration application form and a summary of the Investigator’s Brochure (IB) (also referred to as the research product profile in Vietnam). Upon receipt of the appropriate files, the ASTT will check the validity of the registration dossier within five (5) working days. If any issues are identified, the sponsor must coordinate with the ASTT to complete the dossier within 60 days. The director of the ASTT will issue a written decision within five (5) working days of receiving a complete and valid dossier.

The C-ClinDrugTrialGCP indicates that research institutions must then submit dossiers requesting clinical drug trial approval directly or by post to the ASTT. The ASTT checks the validity of the approval request dossier within five (5) working days. If any issues are identified, the establishment must coordinate with the ASTT to finalize the dossier within 60 days.

The C-ClinDrugTrialGCP requires that within 25 days of receiving a complete and valid approval request dossier, the MOH will produce a written appraisal of the clinical drug research proposal and organize a meeting of the NECBR. Within five (5) working days from the date of the NECBR’s appraisal report, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

If the research proposal is not approved or needs to be corrected, the ASTT shall notify the establishment and state the reason. If any issues are identified, the establishment must coordinate with the ASTT to complete the dossier within 90 days from the date of the notice. Within five (5) working days after receiving the completed research proposal in accordance with the written notice, the ASTT gathers all materials related to the dossier and submits it to the Minister of Health for approval.

EC Approval

The C-ECReg indicates that both the institutional level ECs (CEBRGLs) and the NECBR should issue guidelines for research evaluation submissions, providing information and regulatory forms for investigators. The guidelines should include information regarding the application deadline in relation to the appraisal date, the expected timeframe for notification of a decision, and the timeframe to follow if the EC requires applicants to submit additional information or documents. See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed information on the EC guidelines.

According to an in-country subject matter expert, the review and approval process for CEBRGLs takes one (1) week. Meetings are scheduled upon request and are based on the availability of the majority of its members.

The C-ECReg indicates that EC review under the full process is required for research proposals that are ineligible for review under an expedited process. Review under the full process is also required if, while under expedited process review, the appraiser requests a full process review.

Within 30 days from the receipt date of a complete and valid dossier, the EC must organize an examination of the dossier and notify the applicant of the EC’s decision under both the expedited and full review processes. Within five (5) working days from the date that the research dossier appraisal results are available, the EC must send a written notification to the leading research institution and principal investigator, and must publish the appraisal results on a bulletin board or on the website of the EC or the organization that established the EC. The EC may approve, conditionally approve, or decide not to approve a research dossier, and the written notifications must be issued accordingly.

See the Ethics Committee topic, Scope of Review subtopic for detailed submission process requirements.

Additional Resources
No additional resources
Clinical Trial Lifecycle > Trial Initiation
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Articles 92 and 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 3 and 15
(3) (Regulation) Decision No. 4059/QD-BYT – Stipulating Functions, Duties, Powers and Organizational Structure of the Administration of Science, Technology and Training of the Ministry of Health (D-ASTTReg – English, unofficial translation) (Vietnamese) (Effective October 20, 2012)
Ministry of Health
Relevant Sections: Articles 1-3
(4) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 8 and 16, and Form 1)
(5) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 4, 19, and 21-22
(6) (Regulation) Circular No. 47/2010/TT-BYT – Guiding the Export and Import of Drugs and Packaging in Direct Contact with Drugs (C-ExprtImprtMeds – English, unofficial translation) (Vietnamese) (December 29, 2010)
Ministry of Health
Relevant Sections: Article 3
Summary

Overview

As delineated in the C-ClinDrugTrialGCP, PharmLaw, and D-ASTTReg, a clinical trial can only commence in Vietnam after authorization from the Ministry of Health (MOH) has been received. The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. The C-ClinDrugTrialGCP and PharmLaw indicate that the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers for completeness. The MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research proposal. Per the C-ClinDrugTrialGCP, once the ASTT has completed its review and the NECBR has reviewed and approved the research proposal, the Minister of Health must give final approval to the entire study approval dossier. As indicated in the C-ClinDrugTrialGCP , C-BioequivTrial, and C-ECReg, the applicant must obtain institutional EC approval, prior to NECBR approval. For additional information on the institutional EC and NECBR review processes, please refer to the Ethics Committee topic.

As per the C-ExprtImprtMeds, an import license must be obtained for the shipment of an investigational product (IP) to be used in the trial from the MOH’s Drug Administration of Vietnam (DAV). (See the Investigational Products topic, Manufacturing & Import subtopic for additional information).

As stated in the C-BioequivTrial, all investigators must possess appropriate qualifications, training, and experience. All investigators involved in the trial must obtain completion certificates for a good clinical practice (GCP) course and a safety reporting course, each to be updated every three (3) years, from the MOH or an authorized training facility. The trials should be conducted in compliance with GCP principles and standards outlined in the C-ClinDrugTrialGCP and the C-BioequivTrial Appendix, which are based on the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (VNM-5) and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (Please refer to Annex 3 of The Use of Essential Drugs: Sixth Report of the WHO Expert Committee for these guidelines (VNM-10)).

According to an in-country subject matter expert, the ASTT encourages the sponsor and the principal investigator (PI) to register their study with the United States National Institutes of Health’s ClinicalTrials.gov.

Clinical Trial Agreement

As per the C-BioequivTrial, the sponsor is required to enter an agreement with the participating PI/host institution(s) before the trial begins to demonstrate the financial agreement between the parties. PharmLaw also states that the sponsor is required to sign a clinical trial contract with the investigator(s).

EC Confirmation of Review and Approval

The C-BioequivTrial requires that the study protocol be approved by the national and institutional ECs, prior to the trial’s commencement. (See Ethics Committee topic, Scope of Review subtopic and Clinical Trial Lifecycle topic, Submission Content subtopic for additional details on the EC review process).

Data and Safety Monitoring Board

According to an in-country subject matter expert, there are no requirements for establishing a Data and Safety Monitoring Board (DSMB).

Additional Resources
(1) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (VNM-5) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(2) (International Guidance) The Use of Essential Drugs: Sixth Report of the WHO Expert Committee (VNM-10) (Technical Report Series No. 850) (1995)
World Health Organization
Relevant Sections: Annex 3 (Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products)
Clinical Trial Lifecycle > Safety Reporting
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 15
(2) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 1 and 19-20, and Form 4)
(3) (Guidance) Guide for Decision No. 62/QD-K2DT - Recording, Handling, and Reporting Adverse Event and Serious Adverse Events in Clinical Trials Conducted in Vietnam (G-AERprtingD62 - English, unofficial translation) (Vietnamese) (June 2, 2017)
Ministry of Health
Relevant Sections: 1-3
Summary

Overview

As delineated in the C-BioequivTrial and the G-AERprtingD62, the following definitions provide a basis for a common understanding of Vietnam’s safety reporting requirements:

  • Adverse Event (or Adverse Experience) (AE) – Any untoward medical occurrence (including any signs, symptoms, illnesses, or test results) in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
  • Serious Adverse Event (SAE) – Any untoward medical occurrence that may lead to death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or permanent incapacity, creates a congenital anomaly/birth defect, or requires appropriate medical intervention to prevent the aforementioned situations or medically important event
  • Unexpected AE – AEs in which the essence, severity, specificity, or consequences are different or have not been recorded or considered in the study protocol or relevant study documents

Also, according to an in-country subject matter expert, the Ministry of Health (MOH) uses the International Council for Harmonisation's Guideline for Good Clinical Practice E6(R2) (VNM-5) to define its safety reporting terminology.

Reporting Requirements for AEs/SAEs

Investigator Responsibilities

As per the C-BioequivTrial and the G-AERprtingD62, the principal investigator (PI) is responsible for detecting and settling SAEs and updating AE/SAE information to ensure the timeliness of reporting and the safety of the research participants. The PI is required to report to the sponsor, the institutional ethics committee (EC), also known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), the MOH’s National Ethics Committee in Biomedical Research (NECBR), the MOH’s Administration of Science, Technology and Training (ASTT), and the National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI and ADR Centre).

The C-ECReg further states that the NECBR is responsible for assessing the PI's recording, reporting, and handling of AEs occurring during the study.

The C-BioequivTrial indicates that depending on the type of AE/SAE, the PI must comply with the following reporting requirements:

  • Fatal or life-threatening SAEs in Vietnam: A report, in accordance with Form 4 in the Appendix of C-BioequivTrial, must be submitted to the NECBR, the ASTT, and the National DI and ADR Centre within seven (7) working days from the date of receiving information about the SAE. Updates on the SAE must be provided in additional reports until the participant recovers or stabilizes.
  • SAEs that are not fatal or life-threatening in Vietnam: A report, in accordance with Form 4 in the Appendix of C-BioequivTrial, must be submitted to the NECBR, the ASTT, and the National DI and ADR Centre within 15 working days from the date of receiving information about the SAE.
  • Non-serious AEs occurring in Vietnam: The AEs must be recorded and summarized in a periodical report, and reported in the full results of the trial research results to the NECBR and the ASTT.

The C-BioequivTrial indicates that in the event of fatal or life-threatening AEs/SAEs, the PI and the host institution are required to suspend the trial immediately, provide care and treatment to the participant(s), overcome and resolve the consequences, and document the events. According to the G-AERprtingD62, the PI must also document any deaths. The C-BioequivTrial and the G-AERprtingD62 further indicate that the PI and the host institution must report these events to the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR.

For AEs that cause harm to the participant’s health, the C-BioequivTrial and the G-AERprtingD62 indicate that the PI is responsible for treating and following up on the participant’s health until he or she is stable.

According to the C-BioequivTrial, the PI should provide periodic updates regarding AEs/SAEs to the sponsor, the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR. If the extent and frequency of AEs/SAEs exceeds the allowable limit, investigators may propose to the sponsor, EC, and competent regulatory authority that the clinical trial be suspended.

The C-BioequivTrial and the G-AERprtingD62 indicate that all the following must be reported:

  • SAEs occurring at study sites in Vietnam;
  • SAEs occurring at study sites outside of Vietnam in a multicenter Vietnamese study that lead to cessation/suspension of the study or a change in the protocol; and
  • All other AEs occurring in clinical drug trials at study sites in Vietnam

Sponsor Responsibilities

Per the C-BioequivTrial and the G-AERprtingD62, the sponsor must coordinate with the PI to report AEs/SAEs occurring at study sites in Vietnam to the CEBRGL, the NECBR, the ASTT, and the National Center of DI and ADR. The sponsor must collect data of AEs/SAEs.

For SAEs occurring at study sites outside of Vietnam in a multicenter Vietnamese study, the sponsor must report to the NECBR, the ASTT, and the National Center of DI and ADR within 10 working days from the date of a decision to stop/suspend the study, withdraw participants from the study, or change the research protocol.

In addition, the sponsor must report findings from clinical studies, epidemiology studies, in vitro studies, and other information that may lead to an important risk of the investigational product (IP).

Form Completion & Delivery Requirements

Per the C-BioequivTrial, SAEs in Vietnam should be reported using a Reporting Form for SAEs in Clinical Trials (Appendix, Form 4).

Data and Safety Monitoring Board

According to an in-country subject matter expert, there are no requirements for establishing a Data and Safety Monitoring Board (DSMB).

Additional Resources
(1) (Document) The National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI & ADR Centre) (VNM-1) (May 2009)
Hanoi University of Pharmacy and Ministry of Health
(2) (International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (VNM-5) (Step 4 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Relevant Sections: 1, 5.16-5.17, and 7
(3) (Webpage) The Uppsala Monitoring Centre - WHO Programme for International Drug Monitoring (VNM-8) (Current as of December 15, 2020)
World Health Organization Collaborating Centre for International Drug Monitoring
Clinical Trial Lifecycle > Progress Reporting
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 23
(2) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 5, 20, and 23, and Form 3)
(3) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Appendix III (Form No. 12)
Summary

Overview

In accordance with C-BioequivTrial and C-ClinDrugTrialGCP, the investigators are responsible for submitting periodic reports. In addition, the principal investigator (PI), host institution, and sponsor are required to submit a final study report to confirm the results of the trial.

Interim/Progress Reports

The C-BioequivTrial indicates that investigators are also responsible for providing periodic and unscheduled reports in accordance with applicable regulations.

According to the C-ECReg, progress reports submitted to ethics committees (EC) for appraisal must contain the following:

  • Summary of research protocol
  • Complete research protocol, including previously approved revisions, if applicable
  • Reports on research progress
  • Reports on the number of participants who were selected for the study, completed the study, and withdrew from the study
  • Detailed report on adverse events and issues causing risks to participants, if applicable
  • Summary of relevant information, especially safety information
  • Current informed consent form (ICF)
  • Independent inspection report of investigator and sponsor
  • Notice of PI or sponsor regarding early suspension/termination or completion of the study, if applicable

Final Report

The C-BioequivTrial and C-ClinDrugTrialGCP indicate that the PI, the sponsor, and the host institution are responsible for submitting a final report to the Ministry of Health (MOH) when a study is completed. The final report, which must include an analysis of the data and information on adverse events/serious adverse events, must be submitted in accordance with Form No. 12 in Appendix III of the C-ClinDrugTrialGCP. The C-BioequivTrial further states that the clinical trial results must be made public within three (3) years from the date of issuance of the competent authorities' decision approving the results, and should comply with applicable copyright regulations.

Additional Resources
No additional resources
Sponsorship > Definition of Sponsor
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Articles 1 and 92
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 2
(3) (Regulation) Circular No. 08/2014/TT-BYT - Rules of Operation Supporting Research Clinical Trials in Vietnam (C-ClinTrialOps – English, unofficial translation) (Vietnamese) (Effective May 1, 2014)
Ministry of Health
Relevant Sections: Articles 3, 9-11, 15, and 17, and Appendix I (Forms No. 1-2)
(4) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Article 1)
(5) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Article 19
Summary

Overview

As per the C-ECReg and the C-BioequivTrial, the sponsor is defined as an individual, entity, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. (Note: The C-ClinDrugTrialGCP and C-BioequivTrial also refer to the sponsor as “organizations and individuals with clinical reagents” or “donor”.)

In addition, per PharmLaw, the sponsor may select a qualified contract research organization (CRO) (also known as a research support organization in Vietnam) to run the clinical trial. The C-ClinTrialOps defines a CRO as an organization with the legal status to operate in the field of clinical trial research support and that is staffed with appropriately qualified personnel.

According to the C-ClinTrialOps, CROs may perform clinical research support activities such as implementing sponsors’ clinical research responsibilities, carrying out administrative support activities, and conducting clinical research monitoring. The C-ClinDrugTrialGCP indicates that a cooperative contract should exist between the sponsor and a CRO, if applicable. According to PharmLaw, a sponsor and his/her CRO may be domestic or foreign.

In addition, as per the C-ClinTrialOps, CROs are also responsible for registering their organizations with the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT). Before implementing any activities in support of a clinical trial, a CRO must submit a registration dossier and the applicable forms for approval. The CRO is also required to report annually on its clinical research activities to the MOH’s ASTT. (See the C-ClinTrialOps for detailed dossier registration requirements and forms.)

Additional Resources
No additional resources
Sponsorship > Trial Authorization
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 94
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 3 and 15
(3) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 21-22 and Appendix III (Form No. 13)
Summary

Overview

In accordance with the C-ClinDrugTrialGCP and PharmLaw, Vietnam requires the sponsor to obtain clinical trial authorization from the Ministry of Health (MOH). The MOH’s Administration of Science, Technology and Training (ASTT) manages the clinical trial review process. The C-ClinDrugTrialGCP indicates that the sponsor is required to submit a clinical trial registration dossier to the ASTT. Following approval of the registration dossier, the research institution must then submit a dossier requesting trial approval to the ASTT.

According to the C-ClinDrugTrialGCP, the ASTT is responsible for reviewing the clinical trial registration and study approval dossiers for completeness. The C-ClinDrugTrialGCP and PharmLaw state that the MOH’s national level ethics committee (EC), the National Ethics Committee in Biomedical Research (NECBR), is responsible for approving the research proposal. Per the C-ClinDrugTrialGCP and PharmLaw, once the ASTT has completed its review of the study approval dossier, and the NECBR has reviewed and approved the research proposal, the Minister of Health must give final approval.

As per the C-ClinDrugTrialGCP, the MOH’s ASTT review process is conducted in parallel with the NECBR review. However, per C-ClinDrugTrialGCP and PharmLaw, the ASTT review will only be finalized once the NECBR approval is obtained, and then the entire study approval dossier will be sent to the Minister of Health for final approval.

In addition, as indicated in the C-ClinDrugTrialGCP and the C-ECReg, the applicant must obtain institutional EC approval prior to NECBR review and approval. According to an in-country subject matter expert, institutional level EC approval is performed by an EC that is registered as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL) with the MOH’s ASTT. For additional information on the institutional EC (CEBRGL) and NECBR review processes, please refer to the Ethics Committee topic.

(See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

Additional Resources
No additional resources
Sponsorship > Insurance
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 5-6 and Form 1)
Summary

Overview

According to an in-country subject matter expert, there is no specific Vietnamese guidance that addresses indemnity agreements between the sponsor and the contract research organization, investigator(s), or institution(s). However, the C-BioequivTrial lists an insurance contract as an essential document to be obtained by the principal investigator, institution, and sponsor before conducting a clinical trial. The purpose of the insurance contract is to ensure that research participants will be compensated in the event of a trial-related injury.

Additional Resources
No additional resources
Sponsorship > Compensation
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 92
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 17
(3) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 5-6 and 21, and Form 1)
Summary

Overview

As specified in PharmLaw, the sponsor is responsible for providing compensation to research participants in the event of trial-related injuries. The C-BioequivTrial also states investigators are responsible for compensating participants when an adverse event that seriously impacts the participant’s health was caused by the investigator’s violation of the research protocol.

According to the C-BioequivTrial, payment and compensation, if any, to clinical trial participants must be clearly indicated in the informed consent form (ICF) and in the research protocol. The C-ECReg also requires that the ICF include information relating to payment for study participants, including the method, amount, and payment schedule. The amount and method of payment should not coerce or excessively influence participants. Payments should be made according to each visit.

Additional Resources
No additional resources
Sponsorship > Quality, Data & Records Management
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 21
(2) (Regulation) Circular No. 08/2014/TT-BYT - Rules of Operation Supporting Research Clinical Trials in Vietnam (C-ClinTrialOps – English, unofficial translation) (Vietnamese) (Effective May 1, 2014)
Ministry of Health
Relevant Sections: Article 3
(3) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Articles 15, 18, and 23, and Forms 1-2)
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Article 19, Appendix II, and Appendix III (Form No. 8)
Summary

Overview

As stated in the C-BioequivTrial, the sponsor is responsible for assigning a monitor to assist in maintaining a quality assurance (QA) system with written standard operating procedures (SOPs) that ensure trials are conducted and data are generated, recorded, and reported in compliance with the protocol.

Electronic Data Processing System

According to the C-BioequivTrial, when using electronic trial data processing systems, the sponsor should use appropriate data handling programs, and SOPs for these systems should be available. In addition, per the C-ClinDrugTrialGCP, the research institution’s general documentation must include a brief description of any electronic document system in its technical and professional standards, if applicable.

Record Management

As per the C-BioequivTrial, the sponsor and the principal investigator (PI) are responsible for filing the following essential documents before the trial begins and during the conduct of the trial:

  • Sample(s) labels attached to investigational product (IP) container(s) (only the sponsor is required to file this information)
  • Instructions for administration and handling of IPs and trial-related materials (if not included in protocol or Investigator’s Brochure (IB))
  • Shipping records for IP and trial-related materials

In addition, the sponsor and the PI are responsible for maintaining records of handling instructions and shipping records for IPs and trial-related materials.

Audit Requirements

As part of its QA system, the C-BioequivTrial states that the sponsor should assign a monitor to audit the quality of the trial. The sponsor should appoint individuals who are independent from the trial and are qualified by training and experience to conduct audits, in accordance with the C-ClinTrialOps. The C-ClinDrugTrialGCP further indicates that SOPs, the audit plan, and procedures must also be submitted to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT).

The C-BioequivTrial indicates that the ASTT may conduct audits to ensure the rights and health of participants in the trial, ensure the quality and integrity of the research data, ensure that the responsibilities of stakeholders in the research are implemented in accordance with applicable regulations, and promptly detect violations of the research protocol. The MOH will determine the audit scale and frequency based on the objective, purpose, design, complexity, blinding technique, scale, and end date of the research. The MOH must send an inspection notice to the sponsor and institution at least five (5) days before the audit, and the inspection report must be completed and sent to the sponsor and institution within 20 days of the audit.

According to the C-BioequivTrial, ethics committees (ECs) may also conduct periodic or unscheduled audits. The sponsor and EC should determine the scale and frequency of the audits based on the objectives and design of the research. The purpose of the audit should be to evaluate trial conduct and PI/study team compliance with the protocol, SOPs, good clinical practices (GCPs), and other applicable regulatory requirements. The sponsor or the EC must send an inspection notice to the institution and PI at least five (5) days before the audit, and the inspection report must be completed and sent to the institution and PI within 20 days of the audit.

The C-ECReg indicates that ECs must conduct periodic audits of ongoing studies within a time period that is consistent with the level of risk for study participants, but at least once a year on or before the date the EC approved the research protocol. The conclusion of the periodic audit results should state that the EC’s previous decisions are still valid, or have been changed, suspended, or revoked. Circumstances for unscheduled audits include:

  • Modification of the protocol that has the potential to affect the rights, safety, and/or interests of the research participants or investigators
  • A serious adverse event related to the research or the research product
  • Discovery of new facts or information that could affect a potential benefit or risk of harm related to the study
  • A request to suspend all or a portion of the study by the sponsor or regulatory agency

Premature Study Termination/Suspension

According to the C-BioequivTrial, the sponsor may terminate a trial early if he/she learns of any serious protocol violations that seriously affect the health of trial participants, or, the accuracy and truthfulness of the data during an audit. The sponsor should send notices to the Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), the MOH’s National Ethics Committee in Biomedical Research (NECBR), and the relevant authority, in addition to notifying the institution and PI.

Multicenter Studies

The C-BioequivTrial states that for multicenter studies, in addition to analyzing general research results, it is necessary to conduct a separate analysis of key safety and efficacy variables on Asian or Vietnamese research populations using drugs for which racial factors are considered to have an effect on efficiency and safety. Furthermore, per the C-ClinDrugTrialGCP, the clinical trial study approval dossier must include documentation certifying the participation of research institutions in multicenter studies in Vietnam.

Additional Resources
No additional resources
Sponsorship > Site/Investigator Selection
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Article 92
(2) (Regulation) Circular No. 08/2014/TT-BYT - Rules of Operation Supporting Research Clinical Trials in Vietnam (C-ClinTrialOps – English, unofficial translation) (Vietnamese) (Effective May 1, 2014)
Ministry of Health
Relevant Sections: Article 15
(3) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Article 3)
Summary

Overview

As set forth in the C-BioequivTrial and PharmLaw, the sponsor is responsible for selecting the investigator(s), the principal investigator (PI), the consultant experts, and the research institutions, taking into account the appropriateness and availability of the study site and facilities. According to the C-ClinTrialOps, a contract research organization (CRO) may perform clinical research support activities, which include carrying out sponsors’ clinical research responsibilities, as well as administrative support activities and clinical research monitoring.

Additional Resources
No additional resources
Informed Consent > Documentation Requirements
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Chapter XI (Articles 90 and 91)
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 2, 16-17, and 23
(3) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Forms 1-2)
(4) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 11, 19-20, and 22, and Appendix III (Form No. 9)
Summary

Overview

In all Vietnamese clinical trials, a freely given informed consent must be obtained from each participant in accordance with the requirements set forth in the C-ClinDrugTrialGCP, C-BioequivTrial, and PharmLaw. As per the C-ClinDrugTrialGCP , C-BioequivTrial, and C-ECReg, the informed consent form (ICF) is viewed as an essential document that must be sent to the Ministry of Health (MOH) as part of the clinical trial study approval dossier, for which the Minister must issue final approval. The research proposal, including the ICF, must also be reviewed and approved by Vietnam’s National Ethics Committee in Biomedical Research (NECBR) and an institutional ethics committee (EC) (Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL)). (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

The C-BioequivTrial states that the principal investigator (PI) or the clinical testing facility is responsible for obtaining written consent from trial participants and/or their legal representative(s) or guardian(s) before carrying out any study procedures.

As per the C-ECReg, the ICF should be provided in easy-to-understand language, suitable for potential research participants and/or their legal representative(s) or guardian(s), to support their ability to give fully informed consent. For participants with limited education, the ICF should be provided and explained verbally. According to the C-BioequivTrial and the C-ECReg, the information should also be presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. PharmLaw further states that the participant, and/or his/her legal representative(s) or guardian(s), should also be given adequate time to consider whether to participate.

Language Requirements

As delineated in the C-ClinDrugTrialGCP, the clinical trial application and accompanying material must be provided in Vietnamese or English. If the document is not available in Vietnamese or English, a notarized translation of the document must be provided in Vietnamese or English.

According to in-country subject matter experts on conducting clinical research in Vietnam, the ICF content should be presented in Vietnamese and English. The English copy serves as a reference to the NECBR. The study information sheet should be in Vietnamese.

Documentation Copies

As per the C-ClinDrugTrialGCP, the C-BioequivTrial, the C-ECReg, and PharmLaw, the participant and/or his/her legal representative(s) or guardian(s) must sign and date the ICF. No information is provided in these sources, concerning copies to be issued to the participant(s) and/or his/her legal representative(s) or guardian(s).

Additional Resources
No additional resources
Informed Consent > Required Elements
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Form 1)
(2) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 19 and 22, and Appendix III (Form No. 9)
Summary

Overview

As delineated in the C-ClinDrugTrialGCP, prior to beginning a clinical trial, the research institution is responsible for submitting a study approval application, including the informed consent form (ICF) and any other information to be provided to the research participant, to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), for approval. The research proposal, including the ICF, must also be reviewed and approved by the MOH’s National Ethics Committee in Biomedical Research (NECBR).

No Coercion

As per the C-BioequivTrial, none of the oral or written information concerning the research study, including the written ICF, should contain any language that may be viewed as coercive to the participant and/or his/her legal representative(s) or guardian(s).

ICF Required Elements

Based on the C-ClinDrugTrialGCP, the ICF should include the following statements or descriptions, as applicable:

  • Description of research with an explanation of its purpose and objectives
  • Expected duration of study
  • Research methods to be followed
  • Inclusion and exclusion criteria for research participants
  • Identification of investigator(s) who will be responsible for assessing confidential medical information to select study participants
  • Number of participants involved in the study
  • Description of any foreseeable risks to the participant
  • Any expected benefits to the participant and/or the community, and any study-related payment to the participant
  • Alternative procedures or treatment that may be available to the participant
  • The extent to which confidentiality of records identifying the participant will be maintained
  • Selection of those parties who will be able to access, inspect, supervise and monitor the participant’s records
  • Compensation and/or medical treatment available in the event of a trial-related injury
  • Person(s) to contact for further information regarding the trial and the rights of trial participants and whom to contact in the event of trial-related injury
  • Statement that participation is voluntary and he/she may withdraw at any time for any reason
Additional Resources
No additional resources
Informed Consent > Compensation Disclosure
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 17
(2) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Appendix III (Form No. 9)
Summary

Overview

In accordance with the C-ClinDrugTrialGCP, the informed consent form (ICF) should contain statements describing compensation related to participation in the trial and trial-related injury.

Compensation for Participation in Research

According to the C-ECReg, the ICF should include information relating to payment for study participants, including the method, amount, and payment schedule. The amount and method of payment should not coerce or excessively influence participants. Payments should be made according to each visit.

Compensation for Injury

As per the C-ClinDrugTrialGCP, the ICF should include a statement advising the participant that compensation and medical treatment is available in the event of any trial-related injury. (See the Informed Consent topic, Required Elements subtopic for additional details on what should be included in the ICF.)

Additional Resources
No additional resources
Informed Consent > Participant Rights
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Chapter XI (Article 91)
(2) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 17
(3) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Appendix III (Form No. 9)
Summary

Overview

In accordance with the C-ClinDrugTrialGCP, Vietnam’s ethical standards promote respect for all human beings and safeguard the rights of research participants. A participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process.

The Right to Participate, Abstain, or Withdraw

As stated in the C-ClinDrugTrialGCP and PharmLaw, the participant and/or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary and that he/she may withdraw from the research study at any time for any reason without being held liable.

Additionally, PharmLaw states that participants have the responsibility to comply with investigators’ instructions according to approved clinical trial documents.

The Right to Information

As per the C-ClinDrugTrialGCP and PharmLaw, a potential research participant and/or his/her legal representative(s) or guardian(s) has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, and any compensation or treatment in the case of injury.

The Right to Privacy and Confidentiality

According to the C-ClinDrugTrialGCP and PharmLaw, all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right.

The Right of Inquiry/Appeal

The C-ClinDrugTrialGCP states that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for a person to contact regarding trial-related inquiries.

Furthermore, PharmLaw states that the participant has the right to file a complaint or lawsuit against any illegal acts committed by the sponsor or investigator.

The Right to Safety and Welfare

As set forth in the C-ECReg, the risks to the research participant must take precedence over any anticipated benefits to the participant and the interests of society.

See the Informed Consent topic, and the subtopics of Required Elements and Vulnerable Populations for additional information regarding requirements for participant rights.

Additional Resources
No additional resources
Informed Consent > Special Circumstances/Emergencies
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 16
Summary

Overview

The C-ECReg indicates an ethics committee (EC) may waive the requirement for written voluntary consent from research participants if the study requires absolute confidentiality, or for research in emergency situations where the participant and/or his/her legal representative(s) or guardian(s) cannot voluntarily agree to participate in the study. The EC’s decision to waive the voluntary written consent requirement must consider the benefits and risks of the study to the participants, as well as measures to protect the rights and safety of the participants.

Additional Resources
No additional resources
Informed Consent > Vulnerable Populations
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Article 17
Summary

Overview

As per the C-ECReg and VNM-4, in all Vietnamese clinical trials, research participants selected from vulnerable populations must be provided additional protections by the ethics committee and the investigator(s) to safeguard their health and welfare during the informed consent process. VNM-4 characterizes vulnerable populations as those incapable of giving consent, which may include children, pregnant women, people with mental disabilities, people living with HIV/AIDS, people who are illiterate, prisoners, detainees, sex workers, and other special populations.

See the Informed Consent topic, and the subtopics of Children/Minors; and Pregnant Women, Fetuses & Neonates for additional information about these vulnerable populations.

Additional Resources
(1) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (VNM-4) (July 12-13, 2007)
Family Health International and Vietnam Ministry of Health
Relevant Sections: Approval of Protocol, Monitoring and Evaluation, Final Review, and Dissemination of Research and Ethical Aspects of Biomedical Research
Informed Consent > Children/Minors
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Chapter XI (Article 90)
(2) (Legislation) Law No. 25/2004/QH11 on Child Protection, Care, and Education (ChildLaw – Vietnamese) (Effective January 1, 2005)
The National Assembly
Relevant Sections: Chapter I (Article 1)
(3) (Regulation) Circular No. 4/TT-BYT – Regulations on the Establishment, Functions, Duties, and Powers of the Ethics Committee in Biomedical Research (C-ECReg – Vietnamese) (Effective March 15, 2020)
Ministry of Health
Relevant Sections: Articles 2 and 23
Summary

Overview

According to ChildLaw, a child is someone under 16 years of age.

As set forth in PharmLaw, when the participant is a minor, informed consent must be obtained from his/her legal representative(s) and/or guardian(s).

The C-ECReg further specifies that a signed assent form is required for participants who do not have the capacity to give legal consent, including children from 12 years old to under 16 years old, a person with inadequate civil act capacity, or a patient in a limited cognitive condition. The assent form should contain information similar to an informed consent form (ICF), but is written simply and concisely, and is easier to understand. For participants from seven (7) years old to under 12 years old, the assent form content should be provided and explained verbally. Separate signed ICFs are also required for:

  • Parents and/or legal guardian(s), if the participant is under 16 years old
  • Participants and their parents and/or legal guardian(s), if the participant is 16 years old to under 18 years old
  • Participants that are 18 years or older and have full civil capacity to give consent
Additional Resources
No additional resources
Informed Consent > Pregnant Women, Fetuses & Neonates
Last content review/update: May 13, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Chapter XI (Article 90)
Summary

Overview

PharmLaw states that for studies involving women who are pregnant or breastfeeding, the rationale for participant selection and appropriate protection measures for these participants must be clearly stated in the study approval dossier.

Additional Resources
No additional resources
Informed Consent > Prisoners
Last content review/update: May 13, 2020
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Informed Consent > Mentally Impaired
Last content review/update: May 13, 2020
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Investigational Products > Definition of Investigational Product
Last content review/update: May 13, 2020
Requirements
(1) (Regulation) Circular No. 03/2012/TT-BYT – Guidelines for Clinical Trials on Drugs (Partially repealed) (C-ClinDrugTrial – English, unofficial translation) (Vietnamese) (Effective March 20, 2012)
Ministry of Health
Relevant Sections: Chapter II (Article 5)
Summary

Overview

The C-ClinDrugTrial defines an investigational product (IP) as a pharmaceutical product, biomedical product, vaccine, oriental medicine or drug made from medicinal materials that contain a new active ingredient or substance, or a product with a new combination of already marketed pharmaceutical substances.

Additional Resources
No additional resources
Investigational Products > Manufacturing & Import
Last content review/update: December 15, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Chapter II (Article 10) and Chapter V Section 2 (Article 60)
(2) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Article 19
(3) (Regulation) Circular No. 47/2010/TT-BYT – Guiding the Export and Import of Drugs and Packaging in Direct Contact with Drugs (C-ExprtImprtMeds – English, unofficial translation) (Vietnamese) (December 29, 2010)
Ministry of Health
Relevant Sections: Chapter I (Articles 4-5) and Chapter III (Item II, Articles 11 and 17) and Annex I (Form 11a)
Summary

Overview

As set forth in PharmLaw and the C-ClinDrugTrialGCP, the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) has overall responsibility for authorizing the manufacture of all drug products. According to VNM-4, once the ASTT reviews and the Minister of Health approves the study approval dossier, the Drug Administration of Vietnam (DAV) coordinates with the ASTT to review and approve the investigational product (IP) for manufacture or import.

As per the C-ClinDrugTrialGCP, the sponsor provides the following IP documentation in the study approval dossier:

  • Composition, formulation, and manufacturing processes
  • Quality standards
  • Manufacturer-issued Good Manufacturing Practice (GMP) certificate

In addition, the C-ClinDrugTrialGCP states that IPs which are under review for phase IV clinical trials require a certified or notarized copy of the written request for phase IV clinical drug testing from the respective regulatory authorities.

As delineated in the C-ExprtImprtMeds, the MOH’s DAV is responsible for authorizing the import and export of drugs in Vietnam. According to C-ExprtImprtMeds, IPs for use in clinical trials are categorized as finished drugs without registration numbers. Once the MOH approves the study approval dossier, an import permit application must be submitted to the MOH’s DAV for approval of the IP. The import permit is valid for one (1) year.

PharmLaw further indicates that a drug/medicinal ingredient that does not have a certificate of free sale must be licensed for import with a quantity not exceeding that which is written on the import license when it is to be used in a clinical trial, a bioequivalence study, a bioavailability assessment, or as a sample for registration, testing, scientific research, or display at a fair or exhibition.

The C-ExprtImprtMeds requires the following documents to be included in an import permit dossier:

  • Import order form (three (3) copies) (forms are referenced in the C-ExprtImprtMeds, but are unavailable in this translation)
  • Copy of study protocol approved by the MOH
  • A Certificate of Pharmaceutical Product (CPP) (may be substituted with a Free Sale Certificate (FSC) or GMP certificate)
  • Quality standards and testing methods
  • Drug label(s) and instruction manual(s) with importer seal (See Investigational Products topic, Labeling & Packaging subtopic for detailed labeling requirements)
  • Preclinical and clinical records for drug(s) containing new pharmaceutical substances, or drug(s) with new combinations of circulating pharmaceutical substances, and an information sheet on placebo’s composition, if applicable

According to the C-ExprtImprtMeds, dossiers and documents attached to the order form must be prepared on size A4 paper and bound into a solid set. The records must be arranged in the order of the table of contents, with separation between the sections. The separators must be numbered for easy reference and must be affixed for certification by the importing enterprise on the first page of each section of the entire dossier and must have a cover page clearly stating: the name of the importer, order number, date of order, and type of order. The application for foreign drug import must be written in Vietnamese or English. If the application is written in English, the information in the package insert must be written in Vietnamese, except for the following information that may be written in other languages ​​with Latin origin:

  • Brand name, generic name, or international generic name of the drug
  • International generic or scientific name of ingredient or ingredient quantity of the drug in case it cannot be translated into Vietnamese
  • Name and address of the foreign enterprise that manufactures or franchises the drug

The MOH’s DAV will review and approve the import permit application within 15 working days from the date of receipt. According to in-country subject matter experts, however, the DAV review and approval process typically takes four (4) to eight (8) weeks, and the drug import permit is valid for one (1) year. See the Vietnamese version of C-ExprtImprtMeds for applicable forms.

Please note: Vietnam is party to the Nagoya Protocol on Access and Benefit-sharing (VNM-2), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). For more information, see VNM-6.

Additional Resources
(1) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (VNM-4) (July 12-13, 2007)
Family Health International and Vietnam Ministry of Health
Relevant Sections: Approval of Protocol, Monitoring and Evaluation, Final Review; Procedures for Manufacture and Import of Medicinal Drugs for Clinical Research
(2) (Document) Nagoya Protocol on Access and Benefit-sharing (VNM-2) (2011)
Convention on Biological Diversity, United Nations
(3) (Document) WHO List of Prequalified Quality Control Laboratories (VNM-3) (51st Edition) (September 7, 2020)
World Health Organization
Relevant Sections: Western Pacific Region
(4) (Webpage) Medicinal Product Regulation and Product Liability in Vietnam: Overview (VNM-9) (July 1, 2019)
Vu, Hien Thi Thu, Tilleke & Gibbons, Practical Law
Relevant Sections: Regulatory Overview – Regulatory Authorities and Manufacturing
(5) (Webpage) Country Profile: Vietnam (VNM-6) (Current as of December 15, 2020)
Access and Benefit-sharing Clearing-house, Convention on Biological Diversity, United Nations
Investigational Products > IMP/IND Quality Requirements
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Form 1)
(2) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Articles 3, 19, and 22
Summary

Overview

According to the C-BioequivTrial, the Investigator’s Brochure (IB) is considered an essential document to submit before a clinical trial may be conducted. Vietnam requires the sponsor to submit a summary of the IB to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) in the clinical trial registration dossier. Research institutions are required to submit the full IB to the ASTT in the study approval dossier. (Note: The C-ClinDrugTrialGCP and C-BioequivTrial also refer to the sponsor as “organizations and individuals with clinical reagents” or “donor”.)

As per the C-ClinDrugTrialGCP and C-BioequivTrial, the IB contains information and data about preclinical research and clinical trials on the investigational product(s) (IPs). The IB also demonstrates that clinical information related to the IP has been provided to the principal investigator (PI).

IB Content Requirements

As specified in the C-ClinDrugTrialGCP, the IB must provide coverage of the following areas:

  • Information about the IP, including the ingredients, production processes, and quality standards
  • For pharmaco-chemical drugs, pharmaceutical drugs, traditional medicines: proof of compliance with Good Laboratory Practices (GLPs) for research institutions or proof of compliance with Good Manufacturing Practices (GMPs) (also referred to as good medicine production standards in Vietnam) for drug manufacturers
  • For vaccines: proof of compliance with quality testing requirements from national inspection agencies or ex-warehousing certificates for vaccine or biological batches
  • Preclinical research documents for the IP: research reports on pharmacological effects, toxicity, safety, recommendations on dosage, route of administration, and usage
  • Clinical research papers from the previous stages (if clinical trials are recommended in the next stage and the IP is not subject to exemption from previous stages)

Drug Manufacturing Certificate

The C-ClinDrugTrialGCP specifies that the IPs must be manufactured in a GMP-certified facility. The research institutions must also include a copy of the GMP certificate in the study approval dossier that is submitted to the ASTT.

(See the Investigational Products topic, Manufacturing & Import subtopic for detailed manufacturing requirements and the Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Additional Resources
(1) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (VNM-4) (July 12-13, 2007)
Family Health International and Vietnam Ministry of Health
Relevant Sections: Approval of Protocol, Monitoring and Evaluation, Final Review; Procedures for Manufacture and Import of Medicinal Drugs for Clinical Research
(2) (Webpage) Medicinal Product Regulation and Product Liability in Vietnam: Overview (VNM-9) (July 1, 2019)
Vu, Hien Thi Thu, Tilleke & Gibbons, Practical Law
Relevant Sections: Regulatory Overview – Regulatory Authorities and Manufacturing
Investigational Products > Labeling & Packaging
Last content review/update: May 13, 2020
Requirements
(1) (Legislation) Law No. 105/2016/QH13 on Pharmacy (PharmLaw – English, unofficial translation) (Vietnamese) (Effective January 1, 2017)
The National Assembly
Relevant Sections: Chapter XI (Article 88)
Summary

Overview

Investigational product (IP) labeling in Vietnam must comply with the requirements set forth in PharmLaw.

As set forth in PharmLaw, the IP must be clearly labeled with the wording: “Products used for clinical trials. Use for other purposes is prohibited.” While there is no specified language requirement for IP labeling in the regulatory resources, according to an in-country subject matter expert, this wording must be in written in Vietnamese. A sample IP with the label in the smallest packed unit must also be included in the study approval dossier.

(See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

Additional Resources
No additional resources
Investigational Products > Product Management
Last content review/update: December 15, 2020
Requirements
(1) (Regulation) Circular No. 10/2020/TT-BYT – Regulations on Drug Bioequivalence Trials (C-BioequivTrial – Vietnamese) (GoogleTranslate-C-BioequivTrial)(Effective August 10, 2020)
Ministry of Health
Relevant Sections: Appendix (Article 22 and Forms 1-2)
(2) (Regulation) Circular No. 29/2018/TT-BYT – Regulations for Clinical Trials on Drugs (Appendix I repealed) (C-ClinDrugTrialGCP – Vietnamese) (Effective January 1, 2019)
Ministry of Health
Relevant Sections: Article 3
Summary

Overview

According to the C-BioequivTrial, the Investigator’s Brochure (IB) is considered an essential document to submit before a clinical trial may be conducted. As per the C-ClinDrugTrialGCP and C-BioequivTrial, the IB contains information and data about preclinical research and clinical trials on the investigational product(s) (IPs). The IB demonstrates that clinical information related to the IP has been provided to the principal investigator (PI).

Investigational Product Supply, Storage, and Handling Requirements

The C-BioequivTrial indicates that at the end of a clinical trial, the PI must inventory the IP. The sponsor is responsible for storing the IP and for working with the host institution to revoke and destroy the unused or remaining products, in accordance with applicable regulations.

Record Requirements

As stated in the C-BioequivTrial, the sponsor and the PI are responsible for filing the following essential documents before the trial begins and during the conduct of the trial:

  • Sample(s) labels attached to IP container(s) (only the sponsor is required to file this information)
  • Instructions for handling IPs and trial-related materials (if not included in protocol or IB)
  • Shipping records for IP- and trial-related materials

In addition, the sponsor and the PI are responsible for maintaining records of handling instructions and shipping records for IPs and trial-related materials.

Additional Resources
No additional resources
Specimens > Definition of Specimen
Last content review/update: May 13, 2020
Requirements
(1) (Regulation) Circular No. 40/2018/TT-BYT – On the Management of Infectious Diseases (C-MgmtInfectiousDiseases – Vietnamese) (Effective January 25, 2019)
Ministry of Health
Relevant Sections: Chapter I (Article 2)
Summary

Overview

In Vietnam, as per the C-MgmtInfectiousDiseases, specimens are defined as human blood, serum, plasma, urine, feces, human body fluids, and other specimens that contain infectious substances and microorganisms pathogenic to humans. In addition, as per the C-MgmtInfectiousDiseases, infectious substances are those that are known or expected to contain pathogens affecting humans, and are classified as Category A and B. Category A specimens are those capable of causing life-threatening diseases, death, or permanent disability to humans when they are exposed (see Appendix I of the C-MgmtInfectiousDiseases). Category B specimens are those not listed in Category A.

Additional Resources
No additional resources
Specimens > Specimen Import & Export
Last content review/update: May 13, 2020
Requirements
(1) (Regulation) Circular No. 40/2018/TT-BYT – On the Management of Infectious Diseases (C-MgmtInfectiousDiseases – Vietnamese) (Effective January 25, 2019)
Ministry of Health
Relevant Sections: Chapter III (Article 11) and Appendix II
(2) (Regulation) Decree No. 155/2018/ND-CP – Amendment and Supplement to Some Articles Relating to Business Conditions under State Management of the Ministry of Health (Decree155Amend – Vietnamese) (November 12, 2018)
Socialist Republic of Vietnam
Relevant Sections: Article 15
Summary

Overview

As set forth in the C-MgmtInfectiousDiseases, the Ministry of Health (MOH)’s General Department of Preventive Medicine (DPM) is responsible for authorizing the import and export of infectious specimens.

According to an in-country subject matter expert, effective January 1, 2019, no license is required for the export of specimens. An import license from the DPM is required for infectious specimens.

Decree155Amend requires that application dossiers for the import of infectious specimens include:

  • A written request for the grant of an import license
  • A copy of the competent agency’s approval permitting the implementation of a valid research project, a copy of the approved project proposal or project document, or a copy of the valid written agreement between domestic and foreign establishments regarding the import of specimens
  • A declaration regarding compliance with applicable bio-safety standards

As delineated in Decree155Amend, establishments applying for import permits must submit their dossiers directly or by post to the MOH. If there is no request to amend or supplement the dossier, the MOH shall grant the import license within 15 days from the date of receipt of the application. See Decree155Amend for additional information on import licensing procedures.

Additional Resources
No additional resources
Specimens > Consent for Specimen
Last content review/update: May 13, 2020
Requirements
No applicable regulatory requirements
Summary

No relevant provisions.

Additional Resources
No additional resources
Sections Country Announcement
Country Announcement
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COVID-19 Decision

On August 21, 2020, the Ministry of Health (MOH) issued Decision No. 3659/QD-BYT, which guides research, clinical trials, registration for circulation, and use of the COVID-19 vaccine. Of note, this Decision reinforces the MOH’s ability to exempt certain clinical trial phases based on the recommendation of the Advisory Council, while still ensuring safety and efficacy for patients. (Google translation of Decision)

This message was reviewed on May 3, 2021
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