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
Import & Export
Consent for Specimens

NOTE: Vietnam's new Law on Pharmacy (Law No. 105/2016/QH13) took effect on January 1, 2017. The ClinRegs team is working to update the Vietnam profile where appropriate. Click here for an unofficial translation of the law.

Vietnam
QUICK FACTS
Clinical trial application languageVietnamese
Parallel regulatory and ethical review permittedYes
Clinical trial registration requiredNo
In-country sponsor presence/representation requiredNo
Age of minorsUnder 18
Specimens export allowedYes
Regulatory Authority > Regulatory Authority
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SUMMARY

Overview
As per the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, and DecisionNo4059/QD-BYT, Vietnam’s Ministry of Health (MOH) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections. The MOH grants permission for clinical trials to be conducted in Vietnam.

As indicated in the 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, policies, 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) and good clinical practice (GCP).

In addition, the C-ClinDrugTrial, DecisionNo799/QD-BYT, and DecisionNo4059/QD-BYT state that the MOH’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), is responsible for managing the clinical trial review process. Effective October 2012, as per DecisionNo4059/QD-BYT, the DSTT changed its name to the ASTT. 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.)

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

Phone: 046.2732.273
Fax: 043.8464.051
Email: cuck2dt@moh.gov.vn and vanphongcuck2dt@gmail.com

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Article 2 (4) and Article 4), Chapter IV (Article 17), and Chapter VI (Article 31)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter V (p.14) (3 and 4), Chapter V (p.16) (1), and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 59)

(4) (Regulation) Decree No. 63120121ND-CP of August 31, 2012, Defining the Functions, Tasks, Powers and Organizational Structure of the Ministry of Health (DecreeMOH – Vietnamese/Tiếng Việt) (August 31, 2012)
Government, Socialist Republic of Vietnam

Relevant Sections: Article 1, Article 2 (7, 9 and 16), Article 3, and Article 4 (15)

(5) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

(6) (Regulation) Rules of Operation Supporting Research Clinical Trials in Vietnam (No. 08/2014/TTBYT) (C-ClinTrialOps – English, unofficial translation) (Vietnamese/Tiếng Việt) (May 26, 2014)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter 3 (Articles, 9, 10, and 11) and Forms 1 and 2

Regulatory Authority > Scope of Assessment
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SUMMARY

Overview
In accordance with the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, and DecisionNo4059/QD-BYT, Vietnam’s Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), manages the clinical trial review process for registered and unregistered investigational products (IPs). The ASTT is responsible for reviewing the clinical study documents, and the MOH’s national level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation. The ASTT’s review is conducted in parallel with the EECBR review. However, the ASTT review will only be finalized once the EECBR approval is obtained, and then the entire dossier will be sent to the MOH Minister for final approval. The EECBR approval is also contingent on the institutional EC approval. For additional information on the EECBR review, please refer to the Ethics Committee topic.

As per the C-ClinDrugTrial and the 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
  • Oriental medicines or traditional drugs made from medicinal materials containing new ingredients to be used in humans 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, vaccines, medical devices, combination products, and oriental medicines for which a clinical trial has been conducted, but have not met the MOH’s or internationally recognized good clinical practice (GCP) requirements

As delineated in the DecisionNo799/QD-BYT, the MOH’s ASTT is responsible for reviewing the submitted clinical trial dossier for completeness, organizing the EECBR meeting, and then conducting its review of the investigator’s brochure (IB) portion of the dossier.

Clinical Trial Review Process
As the first step in the review process, the ASTT requires the sponsor to submit registration files that include the clinical trial application form, the principal investigator (PI) and host institution proposal, and the IB. Upon receipt of the appropriate files, the ASTT will respond to the sponsor in writing within 15 working days so that he/she can proceed with the next steps. Once the ASTT clears the registration files, the sponsor is responsible for coordinating with the PI to prepare the required clinical trial files. The sponsor is then responsible for submitting the IB to the ASTT, and the PI is responsible for submitting the protocol and other clinical trial files to the EECBR. Only clinical trials submitted before the 20th of each month will be reviewed in that month; trial files submitted later than the 20th will be reviewed the following month.

Within 30 working days of receiving all required documentation, the ASTT will assign a group to review the IB and will simultaneously organize the EECBR meeting to review and approve the protocol and other trial files. Within 15 working days from receiving the IB review group’s and the EECBR’s reviews, the ASTT will finalize the dossier, and send written notice of the results to the sponsor, the PI and/or the host institution. Within 15 working days following notification of results and completing the supplementary documents, if applicable, the ASTT will compile the dossier and forward to the Minister of Health for final approval. Only clinical trial files that are approved by both the IB review group and the EECBR will be forwarded to the Minister for approval. According to the DecisionNo799/QD-BYT, the entire MOH review and approval process should take approximately 60 working days from the date the sponsor and the PI submit documentation to the ASTT and the EECBR, and the MOH Minister issues his/her final approval. The Minister will typically issue a “Decision” in about 10 working days.
(See the Clinical Trial Lifecycle topic, Submission Process and Submission Content subtopics for detailed submission requirements.)

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Approval of Protocol, Monitoring and Evaluation, Final Review, and Dissemination of Research

 

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Article 2 and 4), Chapter II (Articles 5 and 9), Chapter IV (Article 17), Chapter V (Article 18), Chapter IX (Article 39), and Chapter VI (Article 31)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter III (1 and 2), Chapter V (p.14) (3 and 4), Chapter V (p.16) (1), Annex 7, and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Section III, Article 20), Chapter VIII (Articles 54 and 59)

(4) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

Regulatory Authority > Regulatory Fees
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SUMMARY

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

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Ethics Committee > Ethics Committee
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SUMMARY

Overview
As per DecisionNo460/QD-BYT, DecisionNo111/QD-BYT, and the C-ClinDrugTrial, 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), formerly the Department of Science, Technology and Training (DSTT). National level EC approval is conducted by the MOH’s Ethical Evaluation Committee in Biomedical Research (EECBR). DecisionNo460/QD-BYT and DecisionNo111/QD-BYT state that the EECBR and the CEBRGLs were established by the MOH in 2012 and 2013, respectively.

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

EECBR Composition
As per DecisionNo460/QD-BYT, the EECBR is comprised of the MOH’s Standing Office, the Standing subcommittee, three (3) specialized subcommittees (Pharmaceuticals, Traditional Medicines, and Vaccines), and the secretary team. The EECBR is headed by a chair and vice-chair. The staff consists of three (3) to five (5) specialized officers who are experts from the MOH’s ASTT, and other officers recruited by the chief secretariat.

The Standing Office consists of the EECBR chair and vice-chair, and its membership should be comprised of the following:

  • Both genders
  • Scientific management authorities with good management skills and legal knowledge
  • Lawyers or jurists
  • Lay persons representing research participant rights
  • Scientists with in-depth clinical, epidemiological, pharmaceutical, and statistical research knowledge

Each of the subcommittees consists of seven (7) to nine (9) members who possess good management skills and biomedical research knowledge. The subcommittee members and the secretary team must undergo the MOH’s Good Clinical Practice (GCP) training program. Additional criteria for EC membership are available in Chapter II of DecisionNo460/QD-BYT.

CEBRGL Composition
According to DecisionNo111/QD-BYT, institutional ECs, known as CEBRGLs, should consist of at least five (5) members, and at most 11 members, one of whom will be designated chief secretary. All members must be honest, objective, and have biomedical research ethics knowledge and expertise. The secretary must also have administrative and managerial training. All members must hold a GCP certificate issued by the MOH or an organization accredited by the MOH.

The chair and deputy chair should be prestigious scientists. Council membership should be comprised of the following:

  • Both genders
  • Those inside and outside the biomedical research profession
  • Those unaffiliated with the host institution
  • One who has a professional qualification in law or ethics
  • Those who are medical doctors
  • Those who are scientists with biomedical research knowledge


A secretariat based in the host institution’s Science Research Management Office should assist the CEBRGL with application processing and other administrative tasks. See DecisionNo111/QD-BYT for additional CEBRGL membership criteria.

Terms of Reference, Review Procedures, and Meeting Schedule for the EECBR
As stated in DecisionNo460/QD-BYT, the EECBR must operate within written standard operating procedures (SOPs) which delineate its process for conducting reviews. The EECBR functions as a team with democratic principles when evaluating biomedical research documents. Subcommittee members are responsible for evaluating study documents as assigned by the specialized subcommittee head and forwarding their evaluations to the EECBR’s Standing Office for review. Members must have no conflict of interest with the research being evaluated.

The EECBR’s activities consist of conducting plenary meetings, subcommittee meetings, and periodic and ad-hoc investigations. The standing subcommittee meets monthly, and the specialized subcommittees are required to attend these meetings when relevant documents are being reviewed. Decisions are made by ballot and require 2/3 affirmative votes to be valid. See DecisionNo460/QD-BYT for detailed EECBR procedures.

DecisionNo799/QD-BYT also states that the EECBR should retain all relevant records for at least three (3) years following the trial’s completion and make them available upon request from the MOH.

Terms of Reference, Review Procedures, and Meeting Schedule for the CEBRGLs
As set forth in DecisionNo111/QD-BYT, the CEBRGLs should operate within written SOPs to conduct their reviews. The chairman oversees the meetings, makes conclusions, and reports this information to the institutional head. The council term is three (3) to five (5) years, and 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 EECBR’s SOPs to develop their own SOPs. See DecisionNo111/QD-BYT for detailed CEBRGL review procedures.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Decision – on Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I, Chapter II, and Chapter III

(2) (Regulation) Decision – on Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 3 and 4), Chapter II, and Chapter III

(3) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (Articles 10, 16, and 17)

(4) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (1 and 2)

Ethics Committee > Scope of Review
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SUMMARY

Overview
According to DecisionNo460/QD-BYT, DecisionNo111/QD-BYT, and DecisionNo799/QD-BYT the primary scope of information assessed by the institutional ethics committees (ECs), (also known as the Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs)) and the Ministry of Health’s (MOH’s) Ethical Evaluation Committee in Biomedical Research (EECBR) 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 DecisionNo111/QD-BYT and DecisionNo799/QD-BYT, the ECs must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable. (See Informed Consent topic, and the subtopics of Vulnerable Populations; Children/Minors; and Pregnant Women, Fetuses, and Neonates for additional information about these populations).

DecisionNo460/QD-BYT, DecisionNo111/QD-BYT, and DecisionNo799/QD-BYT also state that the CEBRGLs and the EECBR and 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 DecisionNo460/QD-BYT and DecisionNo111/QD-BYT for detailed ethical review guidelines.

Role in Clinical Trial Approval Process
As delineated in DecisionNo799/QD-BYT, the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), (formerly the Department of Science, Technology and Training (DSTT), review process is conducted in parallel with the national EC review and approval by the EECBR. However, the ASTT’s review will only be finalized once the EECBR approval is obtained, and then the entire application will be sent to the MOH Minister for final approval. In addition, according to an in-country subject matter expert, the PI must obtain approval from the local CEBRGL prior to submitting the application to the EECBR for approval. 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 DecisionNo799/QD-BYT and the C-ClinDrugTrial, the PI in conjunction with the host institution is responsible for preparing the protocol and clinical trial documentation to the EECBR for review and approval. The PI must also coordinate with the sponsor to ensure that the correct documentation has been submitted. The EECBR will only review files submitted before the 20th of each month in that same month. DecisionNo799/QD-BYT indicates that the EECBR review and approval takes 30 working days. The majority of EECBR dossier submissions are approved with comments.
See the Clinical Trial Lifecycle topic, Submission Process subtopic for detailed submission process requirements.)

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Ethical Aspects of Biomedical Research

REQUIREMENTS

(1) (Regulation) Decision – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo460/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Article 5) and Chapter III (Article 9)

(2) (Regulation) Decision – On Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Article 5) and Chapter III (Articles 8 and 9)

(3) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter IV (Articles 15 and 17) and Chapter V (Article 21)

(4) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (1, 2 and 6), Chapter V (p.14) (1-4), Annex 7, and Process of Approval, Review Dossier for Clinical Trial (chart)

Ethics Committee > Ethics Committee Fees
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SUMMARY

Overview
According to an in-country subject matter expert, both the Ethical Evaluation Committee in Biomedical Research (EECBR) and the institutional ethics committees (ECs), also known as the Councils of Ethics in Biomedical Research at the Grass Root Level (CEBRGLs) charge a fee to review clinical trial documentation. The C-ClinDrugTrial states that the host institution and the principal investigator (PI) are responsible for paying a management fee to the Ministry of Health (MOH) to submit a clinical trial application to the EECBR for review. As per further information provided by an in-country subject matter expert, the EECBR currently charges a fee of $1,000-$2,000 USD, and CEBRGLs charge a fee of $500-$2,000 USD depending on the complexity of the trial. In addition, because payments are usually institution-specific, in-country subject matter experts recommend the PI checks with his/her host institution to obtain applicable fee requirements.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter III (Article 13)

Ethics Committee > Authorizing Body
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SUMMARY

Overview
According to an in-country subject matter expert, Vietnam’s Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), 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).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Clinical Trial Lifecycle > Submission Process
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SUMMARY

Overview
In accordance with the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, DecisionNo4059/QD-BYT, DecisionNo460/QD-BYT, and DecisionNo111/QD-BYT, Vietnam requires the sponsor to obtain clinical trial authorization from the Ministry of Health (MOH). The Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), is the department within the MOH that manages the clinical trial review process. The ASTT is responsible for reviewing the clinical trial dossier for completeness and the Investigator’s Brochure (IB). The MOH’s national level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation. As stated in DecisionNo799/QD-BYT and the C-ClinDrugTrial, the principal investigator (PI) in conjunction with the host institution is responsible for preparing the protocol and clinical trial documentation to the EECBR for review and approval. The PI must also coordinate with the sponsor to ensure that the correct documentation has been submitted.

As per the C-ClinDrugTrial, DecisionNo799/QD-BYT, and Additional Resource (B), the ASTT review and the MOH’s approval process is conducted in parallel with the EECBR review. However, the ASTT review will only be finalized once the EECBR approval is obtained, and then the entire dossier will be sent to the MOH Minister for final approval. The EECBR approval is also contingent on the institutional EC approval. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

Delivery Address for Clinical Trial Application
Ministry of Health
Administration of Science, Technology and Training
138A Giang Vo St.
Ba Dinh District
Hanoi City, Vietnam

Phone: 046.2732.273
Fax: 043.8464.051
Email: cuck2dt@moh.gov.vn and vanphongcuck2dt@gmail.com

Assembly and Number of Copies
As per the C-ClinDrugTrial, applicants must submit one (1) signed and stamped original and three (3) hard copies of the completed clinical trial application dossier to the MOH’s ASTT (see Annex 3 in the DecisionNo799/QD-BYT for a copy of the application form).

Clinical Trial Application Language Requirements
As delineated in the C-ClinDrugTrial, the clinical trial application and accompanying material must be provided in Vietnamese. The C-ClinDrugTrial also states that the IB must be in Vietnamese or in English accompanied by a summary in Vietnamese (see form in Annex 2a of DecisionNo799/QD-BYT).

Moreover, according to an in-country subject matter expert , although the official language is Vietnamese, English and/or Vietnamese is acceptable for specific documents. These documents include:

  • Sponsor-prepared clinical trial application form (English)
  • IB (English and Vietnamese)
  • Main study site-prepared clinical trial application form (English and Vietnamese)
  • Study protocol (English and Vietnamese)
  • Informed Consent (IC) form (Vietnamese and English)
  • Drug manufacturing procedures (Vietnamese and English)

The study information sheet, however, should be in Vietnamese, according to this source. In addition, according to an in-country subject matter expert, statements relating to certification of translated consent and assent forms should be handled on a institutional basis.

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Ethical Aspects of Biomedical Research


REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Article 2 (4) and Article 4), Chapter III (Article 10), Chapter IV (Article 17), and Chapter VI (Article 31)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter III (5), Chapter V (p.14) (1, 3, and 4), Chapter V (p.16) (1), Annexes 2a and 3, and  Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 59)

(4) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

(5) (Regulation) Decision – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo460/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I, Chapter II, and Chapter III

(6) (Regulation) Decision – on Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 3 and 4), Chapter II, and Chapter III

Clinical Trial Lifecycle > Submission Content
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SUMMARY

Overview
As per the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, DecisionNo4059/QD-BYT, DecisionNo460/QD-BYT, and DecisionNo111/QD-BYT, 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), formerly the Department of Science, Technology and Training (DSTT), manages the clinical trial review process. The ASTT is responsible for reviewing the clinical trial dossier for completeness and the Investigator’s Brochure (IB). The MOH’s national level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation. The ASTT schedules the EECBR review which also occurs in parallel with the ASTT review. Once the ASTT has completed its review, and the EECBR has reviewed and approved the protocol and other study documentation, the MOH Minister must give final approval to the entire dossier.

The principal investigator (PI) must also obtain institutional EC approval followed by national EC 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. National level EC approval is conducted by Vietnam’s Ethical Evaluation Committee in Biomedical Research (EECBR).

MOH ASTT Requirements
As per the C-ClinDrugTrial and DecisionNo799/QD-BYT, the following documentation must be submitted to the MOH’s ASTT:

  • Clinical trial application form signed by agency/organization/individual who owns the investigational product (IP) (See Annex 3 of DecisionNo799/QD-BYT)
  • Contract/agreement between agency/organization/individual who owns the IP and the host institution; and contract/agreement between agency/organization/individual who owns the IP and the contract research organization (CRO), if applicable (see Annex 5 of DecisionNo799/QD-BYT)
  • Application for protocol review/approval signed by host institution (See Annex 7 of DecisionNo799/QD-BYT)
  • IB (See Annex 2a of DecisionNo799/QD-BYT)
  • Study protocol
  • PI Curriculum Vitae (CV) and Good Clinical Practice (GCP) certificate issued by the MOH or other agencies recognized by the MOH
  • Informed Consent Form (ICF) and study information sheet (See Annex 6 of DecisionNo799/QD-BYT) (See also Informed Consent topic, Required Elements subtopic for additional information)
  • Host institution’s EC (also known as CEBRGL) meeting minutes
  • Written confirmation of participation by the other study sites (for multisite studies only)
  • Approval of the Provincial People Committee (for community-based studies)
  • IP documentation (including a National Institute of Drug Quality Control (NIDQC) issued Certificate of Analysis (CoA) or manufacturer issued Good Manufacturing Practice (GMP) certificate
  • For phase IV clinical trials, original or notarized copies of Pharmaceutical Product (CPP) or Free Sale Certificate (FSC) and GMP certificate from the respective regulatory authorities
  • IP labeling and IP sample photograph

See the C-ClinDrugTrial, and the DecisionNo799/QD-BYT for detailed requirements.

EECBR Requirements
Although the EECBR requirements are not currently available electronically, According to an in-country subject matter expert and Additional Resource (B), the EECBR requires the following documents for its review:

  • Sponsor-prepared clinical trial application form
  • Main study site-prepared clinical trial application form
  • A letter requesting approval
  • Agreement/contract between sponsor and study site(s)
  • Agreement letter to join study from other sites (for multisite studies only)
  • IB
  • Study protocol
  • Local PI and study team CVs
  • Informed consent form (ICF)
  • Study information sheet
  • PI and main study team GCP certificates
  • Institutional EC (CEBRGL) approval and meeting minutes
  • Approval of the Provincial People Committee (for community-based studies)
  • Drug manufacturing procedures and ingredients listing
  • Investigational drug label
  • Certificate of Analysis (CoA) or Certificate of Quality Standards
  • Global report on drug toxicity, safety and pharmacodynamics
  • Full report on studies in previous phases
  • CPP/FSC/GMP, if available from sponsor

CEBRGL Requirements
No information is currently available regarding CEBRGL documentation requirements. As set forth in DecisionNo111/QD-BYT, the CEBRGLs should operate within written standard operating procedures (SOPs) to conduct their reviews.

Clinical Protocol
As per the DecisionNo799/QD-BYT, 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
  • Budget
  • Phase requested
  • Institution to conduct research
  • Organization/individual who owns IP and contact information
  • Background information
  • Objectives
  • Methodology (including trial design, random selection method, and blinding/unblinding procedures)
  • IP storage
  • 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

For detailed information on these elements, refer to Annex 4 of the DecisionNo799/QD-BYT.

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Ethical Aspects of Biomedical Research

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Article 2 (4) and 4), Chapter III (Articles 10 and 11), Chapter IV (Article 17), Chapter V (Article 28), and Chapter VI (Article 31)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter V (p.14) (1-4), Chapter V (1), Chapter V (p.16) (1), Annexes 3, 4, 5, 6, and 7, and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 59)

(4) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

(5) (Regulation) Decision – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo460/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I, Chapter II, and Chapter III

(6) (Regulation) Decision – On Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 3 and 4), Chapter II, and Chapter III

Clinical Trial Lifecycle > Timeline of Review
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SUMMARY

Overview
As stated in the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, DecisionNo4059/QD-BYT, DecisionNo460/QD-BYT, and DecisionNo111/QD-BYT, 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), formerly the Department of Science, Technology and Training (DSTT), manages the clinical trial review process. The ASTT is responsible for reviewing the clinical trial dossier for completeness and the Investigator’s Brochure (IB). The MOH’s national level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation.

The principal investigator (PI) must also obtain institutional EC approval prior to national EC 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.

As per the C-ClinDrugTrial, DecisionNo799/QD-BYT, and Additional Resource (A), the MOH’s ASTT review process is conducted in parallel with EECBR review. However, the ASTT review will only be finalized once the EECBR approval is obtained, and then the entire dossier will be sent to the MOH Minister for final approval. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

MOH Approval
Clinical Trial Application Submission
DecisionNo799/QD-BYT states that the MOH’s review and approval process for a clinical trial application takes 60 working days.

As delineated in the C-ClinDrugTrial, DecisionNo799/QD-BYT, and Additional Resource (A), the first step in the review process is for the sponsor to submit registration files to the ASTT. This documentation includes the clinical trial application form, the study proposal, and the IB. Upon receipt of the appropriate files, the ASTT responds to the sponsor in writing within 15 working days so that he/she can proceed with the next steps. Based on the ASTT’s written authorization, the sponsor coordinates with the PI to prepare the required clinical trial files. The PI is responsible for submitting the protocol and other clinical trial files to the EECBR. Only clinical trials submitted to the ASTT before the 20th of each month will be reviewed in that month; trial files submitted later than the 10th will be reviewed the following month.

Within 30 working days of receiving all required documentation, the ASTT will assign a group to review the IB, and will simultaneously organize an EECBR meeting to review and approve the protocol and other trial files. Within 15 working days of receiving the IB review group’s and the EECBR’s reviews, the ASTT will finalize the dossier and send a written notice of the results to the sponsor, the PI, and/or the host institution. Within 15 working days following notification of results and completing the supplementary documents, if applicable, the ASTT will compile the dossier and forward to the Minister of Health for final approval. The Minister will typically issue a “Decision” in about 10 working days.

EECBR Ethics Approval
The EECBR will only review files submitted before the 20th of each month in that month. DecisionNo799/QD-BYT indicates that the EECBR’s review and approval takes 30 working days. The PI will be required to submit revised documents to the EECBR, who will then approve the study in approximately 15 working days. See the Ethics Committee topic, Scope of Review subtopic for detailed submission process requirements.

There is no stated expiration date for an EC approval in any of the regulatory resources referenced for Vietnam.

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

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Approval of Protocol, Monitoring and Evaluation, Final Review, and Dissemination of Research, Ethical Aspects of Biomedical Research

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Article 2 (4) and 4), Chapter II (Article 5), Chapter IIII (Article 10), Chapter IV (Articles 14, 15, 16, and 17), Chapter V (Article 18), and Chapter VI (Article 31)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter III (Articles 1 and 2), Chapter V (p.14) (1-4), Chapter V (p.16) (1), Annexes 3, 4, 5, 6, and 7, and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Section III, Article 20), and Chapter VIII (Articles 54 and 59)

(4) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

(5) (Regulation) Decision – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo460/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I, Chapter II, and Chapter III

(6) (Regulation) Decision – On Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 3 and 4), Chapter II, and Chapter III

Clinical Trial Lifecycle > Trial Initiation
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SUMMARY

Overview
As delineated in the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, DecisionNo4059/QD-BYT, DecisionNo460/QD-BYT, and DecisionNo111/QD-BYT, a clinical trial can only commence in Vietnam after the sponsor receives authorization from the Ministry of Health (MOH). The MOH’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), manages the clinical trial review process. The ASTT is responsible for reviewing the clinical trial dossier for completeness and the Investigator’s Brochure (IB). The MOH’s national level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation. Once the ASTT has completed its review, and the EECBR has reviewed and approved the protocol and other study documentation, the MOH Minister must give final approval to the entire dossier. No waiting period is required following the applicant’s receipt of these approvals.

As per the C-ClinDrugTrial and Additional Resource (A), the sponsor is required to obtain an import license for the shipment of an investigational product 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-ClinDrugTrial and DecisionNo799/QD-BYT, all investigators must possess appropriate qualifications, training, and experience. All investigators involved in the trial must have had formal training in good clinical practices (GCPs), and submit proof that a GCPs course has been completed. The trials should be conducted in compliance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) and the World Health Organization’s (WHO) Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products.

As per the C-ClinDrugTrial and DecisionNo799/QD-BYT, the sponsor is required to sign a letter of agreement with the participating institution(s) before the trial begins.

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

Clinical Trial Agreement
As per the C-ClinDrugTrial and DecisionNo799/QD-BYT, after obtaining a copy of the EECBR approval, the sponsor is required to sign a letter of agreement with the participating host institution(s) before the trial begins.

EC Confirmation of Review and Approval
DecisionNo799/QD-BYT indicates that the sponsor must obtain national EECBR approval of the study protocol submission 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
Although the C-ClinDrugTrial does not appear to mandate establishing a Data and Safety Monitoring Board (DSMB), a DSMB must be established when required by the MOH.

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Approval of Protocol, Monitoring and Evaluation, Final Review; Procedures for Manufacture and Import of Medicinal Drugs for Clinical Research

(B) (Website) Drug Administration of Vietnam (DAV) (Vietnamese/Tiếng Việt) (Current as of August 28, 2014)
Ministry of Health, Socialist Republic of Vietnam

(C) (WHO Guidance) Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (Technical Report Series No. 850, Annex 3) (1995) World Health Organization, Geneva, Switzerland

(D) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 2 (4 and 10), 3, and 4), Chapter II (Article 5), Chapter III (Article 10 and 11), Chapter IV (Article 17), Chapter V (Articles 18 and 28), Chapter VI (Articles 31 and 33), and Chapter VII (Article 35)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections:  Chapter I (3), Chapter II (2) Chapter III (1, 2, 3, and 8), Chapter V (p.14) (1-4), Chapter V (p.16) (1), Annexes 3, 4, 5, 6, and 7, and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Section III, Article 20), and Chapter VIII (Articles 54 and 59)

(4) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

(5) (Regulation) Decision – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo460/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I, Chapter II, and Chapter III

(6) (Regulation) Decision – on Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 3 and 4), Chapter II, and Chapter III

Clinical Trial Lifecycle > Safety Reporting
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SUMMARY

Overview
As delineated in the ASTTNo-6586, 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 in a participant to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product
  • Adverse Drug Reaction (ADR) – Any noxious and unintended response in a participant to an investigational medicinal product which is related to any dose administered to that participant
  • Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (SADR)– Any untoward medical occurrence that at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
  • Suspected Unexpected Serious Adverse Reaction (SUSAR) – A serious adverse reaction where the nature and severity of the event is inconsistent with the medicinal product

According to an in-country subject matter expert, the Ministry of Health (MOH) uses the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) to define its safety reporting terminology.

Reporting Requirements for AEs/ADRs
Investigator Responsibilities
As per the ASTT-No-6586, the principal investigator (PI) is responsible for detecting and settling SAEs/SADRs to ensure the timeliness of reporting and the safety of the research participants. For all SAEs/SADRs, the PI is required to report to the sponsor and the institutional ethics committee (EC), also known as a Council of Ethics in Biomedical Research at the Grass Root Level (CEBRGL), within 24 hours of learning of the event. Depending on the type of SAE/SADR, the PI must comply with the following reporting requirements:

  • Fatal or life-threatening SAEs/SADRs: The PI coordinates with the sponsor to complete the information and send the report to the MOH’s EC, also known as the Ethical Evaluation Committee in Biomedical Research (EECBR). The initial report must be prepared in writing as early as possible but no later than seven (7) days from the date of receiving the SAE/SADR information. A detailed follow-up report must be completed and sent within 15 days from the date of receiving the SAE/SADR notification. (See Appendix 1 of the ASTTNo-6586)
  • For SAEs/SADRs that are not fatal or life-threatening: The PI coordinates with the sponsor to complete the information and sends the detailed SAE/SADR report to the MOH’s EECBR as early as possible but no later than 15 days from the date of SAE/SADR notification.


In addition, as specified in the C-ClinDrugTrial and DecisionNo799/QD-BYT, in the event of an SAE/SADR, 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, document the events, and submit an SAE/SADR report to the sponsor. The PI should decide whether to continue the trial pending the health status of the injured participant(s). In the case of SAEs/SADRs that are expected and are effectively treated, the trial should continue.

According to DecisionNo799/QD-BYT, the PI should also report regularly (every three (3) months) to the sponsor and the EECBR on the investigational product’s (IP’s) safety, any AEs/ADRs, and the study’s progress; and report immediately if any SAE/SADR seriously affects the participant’s health. In addition, according to an in-country subject matter expert, Vietnam requires all SAEs to be reported (not only drug-related SAEs or SUSARs).

Sponsor Responsibilities
As delineated in the DecisionNo799/QD-BYT, the sponsor is required to report to the EECBR and the MOH’s ASTT immediately (if required) and periodically about the trial’s progress, safety concerns of trial participants, and IP-related safety information, and any AEs/ADRs or SAEs/SADRs. The institution should suspend or terminate the trial early if AEs/ADRs or SAEs/SADRs are determined to be related to the IP and are determined to seriously affect the health of the trial participant(s).

DecisionNo799/QD-BYT also states that the sponsor should suspend or terminate the investigator(s) and the institution’s participation in a trial upon identifying serious infringements, noncompliance with the protocol, or a SUSAR that seriously impacts the health of the participants.

Form Completion & Delivery Requirements
According to an in-country subject matter expert, AEs/ADRs, SAEs/SADRs, and SUSARs should be reported on the MOH’s Reporting Form for Severe Adverse Events, included in ASTTNo-6586, or the Council for International Organizations of Medical Sciences (CIOMS) Adverse Reaction Report Form (CIOMS Form I).

Data and Safety Monitoring Board
Although the C-ClinDrugTrial does not mandate establishing a Data and Safety Monitoring Board (DSMB), a DSMB must established when required by the MOH.

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Pharmacovigilance and Reporting of Adverse Drug Reactions

(B) (Form) Council for International Organizations of Medical Sciences (CIOMS) Adverse Reaction Report Form (CIOMS Form I) (Current as of April 27, 2015)
Council for International Organizations of Medical Sciences, Geneva, Switzerland

(C) (Document) The National Centre of Drug Information and Adverse Drug Reactions Monitoring (National DI & ADR Centre) (May 2009)
Hanoi University of Pharmacy and Ministry of Health, Socialist Republic of Vietnam

(D) (Website) The Uppsala Monitoring Centre – WHO Programme Members (Current as of March 2, 2017)
World Health Organization Collaborating Centre for International Drug Monitoring

(E) (ICH Guidance) International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1) (ICH-GCPs) (Step 4 Version) (June 10, 1996)
International Conference on Harmonisation
Geneva, Switzerland

Relevant Sections: 1, 5.6.2, 5.12.2, 5.14, 5.15, and 7

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter V (Article 23) and Chapter VII (Article 35)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (1, 2, 3, 4, 6, and 7), Chapter V (p.14) (1, 3, and 4), Chapter V (p.16) (1 and 2), 1-Guidelines Needed for Document List Before Conducting the Clinical Trial,  Annex 7, and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Guidance) Instruction on reporting, recording SAE in clinical trial (No. 6586_BYT-K2DT) (ASTTNo-6586) (Vietnamese/Tiếng Việt) (October 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Clinical Trial Lifecycle > Progress Reporting
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SUMMARY

Overview
In accordance with DecisionNo799/QD-BYT, the principal investigator (PI) is responsible for submitting progress reports on the status of the trial and for submitting a final study report.

Interim/Progress Reports
As stated in DecisionNo799/QD-BYT, the PI is required to send progress reports to the sponsor and the national ethics committee (EC), also known as the Ethical Evaluation Committee in Biomedical Research (EECBR), every three (3) months from the date of the trial’s initiation. The progress report should contain the following:
•    Investigational product (IP) safety and side effects
•    Serious Adverse Events (SAEs)/Serious Adverse Drug Reactions (SADRs)/Suspected Unexpected Serious Adverse Reactions (SUSARs)

Final Report
DecisionNo799/QD-BYT requires the PI to submit a final report to the sponsor, the host institution, and the EECBR when a study is completed.The final report must be consistent with the protocol, and signed by the sponsor, the monitor, and the statistician.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (5) and Chapter V (1 and 2)

Sponsorship > Definition of Sponsor
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SUMMARY

Overview
As per DecisionNo799/QD-BYT, the sponsor is defined as an individual, company, entity, or organization which takes responsibility for the initiation, management and/or financing of a clinical trial. The C-ClinDrugTrial defines a contract research organization (CRO) as an organization with legal status, with appropriately qualified personnel meeting the Ministry of Health (MOH)’s requirements, and as an entity independent from the sponsors and institutions owning the investigational products.

DecisionNo799/QD-BYT states that the sponsor can transfer any or all responsibilities to the investigators or to the research institution, who, in turn, may authorize a CRO to carry out these trial-related duties. However, the sponsor is ultimately responsible for ensuring the quality and integrity of the data and the proper conduct of the trial. Any trial-related responsibilities to be transferred and assumed by the investigators, the research institution, or a CRO should be specified in a written agreement or contract. According to the PharmLaw, a sponsor may be domestic or foreign.

In addition, as per the C-ClinTrialOps, the CROs are also responsible for registering their organizations with the MOH’s Administration of Science, Technology and Training (ASTT), (formerly the Department of Science, Technology and Training (DSTT)). 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

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3) and Chapter III (3)

(2) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 59)

(3) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter I (Article 2 (6))

(4) (Regulation) Rules of Operation Supporting Research Clinical Trials in Vietnam (No. 08/2014/TTBYT) (C-ClinTrialOps – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 26, 2014)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter 3 (Articles, 9, 10, and 11), Chapter 4 (Article 17), and Forms 1 and 2

Sponsorship > Trial Authorization
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SUMMARY

Overview
In accordance with the C-ClinDrugTrial, DecisionNo799/QD-BYT, the PharmLaw, DecisionNo4059/QD-BYT, DecisionNo460/QD-BYT, and DecisionNo111/QD-BYT, 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), formerly the Department of Science, Technology and Training (DSTT), manages the clinical trial review process. The ASTT is responsible for reviewing the clinical trial dossier for completeness and the Investigator’s Brochure. The MOH’s national level ethics committee (EC), the Ethical Evaluation Committee in Biomedical Research (EECBR), is responsible for approving the protocol and study documentation. Once the ASTT has completed its review, and the EECBR has reviewed and approved the protocol and other study documentation, the MOH Minister must give final approval to the clinical study dossier.

The sponsor must also ensure that the principal investigator (PI) submits the correct documentation to obtain institutional EC approval followed by national EC 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.

As per the C-ClinDrugTrial, DecisionNo799/QD-BYT, and Additional Resource (A), the MOH’s ASTT review process is conducted in parallel with the EECBR review. However, the ASTT review will only be finalized once the EECBR approval is obtained, and then the entire dossier will be sent to the MOH Minister for final approval. The EECBR approval is also contingent on institutional EC approval. (See Clinical Trial Lifecycle topic, Submission Content subtopic for detailed submission requirements).

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Ethical Aspects of Biomedical Research

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Article 2 (4) and Article 4), Chapter III (Article 10), Chapter IV (Article 17), and Chapter VI (Article 31)

(2) ( Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter III (3,4, and 5), Chapter V (p.14) (2, 3, and 4), Chapter V (p.16) (1), Annexes 2a and 3, and Process of Approval, Review Dossier for Clinical Trial (chart)

(3) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 59)

(4) (Regulation) Decision No. 4059/QD-BYT Dated 10/22/2012 Stipulating Functions, Duties, Powers and Organizational Structure of the Department of Science, Technology and Education Under the Ministry of Health (DecisionNo4059/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (October 22, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Articles 1, 2, and 3

(5) ( Regulation) Decision – On the Promulgation of Regulations on Organization and Operation of Ethical Evaluation Committee in Biomedical Research of Ministry of Health, Period 2012-2017 (DecisionNo460/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 16, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I, Chapter II, and Chapter III

(6) (Regulation) Decision – on Promulgation of Regulation on Organization and Operation of Council of Ethics in Biomedical Research at Grass-Root Level (DecisionNo111/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (January 11, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 3 and 4), Chapter II, and Chapter III

Sponsorship > Insurance
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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, as set forth in DecisionNo799/QD-BYT, the principal investigator and the sponsor are responsible for discussing, developing, and signing a contract to ensure research participants will be compensated in the event of a trial-related injury. As per the C-ClinDrugTrial, the sponsor is also responsible for compensating trial participants for any trial-related injuries or adverse events.


ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter V (p.16)(1) and 1-Guidelines for Documents Needed Before Conducting the Clinical Trial

(2) (Guidance) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter VI (Article 31)

Sponsorship > Compensation
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As specified in DecisionNo799/QD-BYT and the PharmLaw, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. DecisionNo799/QD-BYT specifically states that the sponsor should provide participants with compensation including property, spiritual, and legal coverage in case of an unexpected adverse reaction from sponsor-owned IP products that seriously impact their health. As set forth in DecisionNo799/QD-BYT, the principal investigator and the sponsor are responsible for discussing, developing, and signing a contract to insure research participants will be compensated in the event of a trial-related injury.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter III (3)

(2) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 57)

Sponsorship > Quality, Data & Records Management
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As stated in the C-ClinDrugTrial and DecisionNo799/QD-BYT, 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. DecisionNo799/QD-BYT indicates that the sponsor or the investigators must sign an agreement with the monitor regarding his/her role in monitoring and reporting on the clinical trial process and verifying the data.

Electronic Data Processing System
According to DecisionNo799/QD-BYT, when using electronic trial data processing systems, the sponsor should use appropriate data handling programs, and SOPs for these systems should be available. The sponsor should also ensure that participants are properly coded and maintain a list of people approved to amend the data.

Record Management
As per DecisionNo799/QD-BYT, 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 handling 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-ClinDrugTrial and DecisionNo799/QD-BYT state that the sponsor should assign a monitor to audit the quality of the trial. The monitor should audit the trial site at least every six (6) months, and submit the monitoring report to the Ethical Evaluation Committee in Biomedical Research (EECBR), the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT) (formerly the Department of Science, Technology and Training (DSTT)), and the sponsor. 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 should appoint individuals who are independent from the trial and are qualified by training and experience to conduct audits. The SOPs, audit plan, and procedures must also be submitted to the MOH’s ASTT.

Premature Study Termination/Suspension
DecisionNo799/QD-BYT and the C-ClinDrugTrial state that the sponsor may use urgent measures to suspend or terminate the PI’s and the research institution’s participation or terminate a trial early if he/she learns of any serious violations, protocol noncompliance, or adverse events that seriously affect the health of trial participants.

Multicenter Studies
As per the C-ClinDrugTrial, when multicenter studies are conducted, the host institution must establish a joint steering committee. The committee is comprised of one (1) PI, PIs from other sites, and representatives from lead research institutions in order to reach the trials’ objectives, content, evaluation criteria, plans, and timelines.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter V (Article 23), Chapter VI (Article 30), and Chapter VII (Article 34)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter III (4), and Chapter V (p.16) (1, 2, 3, and 4)

Sponsorship > Site/Investigator Selection
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As set forth in the C-ClinDrugTrial, DecisionNo799/QD-BYT, and the PharmLaw, the sponsor is responsible for selecting the investigator(s), the principal investigator (PI), the consultant experts, and the host institutions, taking into account the appropriateness and availability of the study site and facilities. DecisionNo799/QD-BYT also states that the sponsor may also transfer any or all responsibilities to the investigators or to the research institution, who, in turn, may authorize a contract research organization (CRO) to carry out these trial-related duties.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter VI (Article 30)

(2) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Section: Chapter VIII (Article 58)

(3) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (3 and 4)

Informed Consent > Documentation Requirements
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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 DecisionNo799/QD-BYT. As per DecisionNo799/QD-BYT, the informed consent form (ICF) is viewed as an essential document that must be reviewed and approved by Vietnam’s Ethical Evaluation Committee in Biomedical Research (EECBR), then sent to the Ministry of Health (MOH) as part of the clinical trial dossier for which the Minister must issue final approval. (See the Informed Consent topic, Required Elements subtopic for details on what should be included in the form.)

DecisionNo799/QD-BYT states that the principal investigator (PI) or the PI’s assigned study staff 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 DecisionNo799/QD-BYT, the ICF should be translated to all applicable languages, and the participant(s) and/or his/her legal representative(s) or guardian(s) should be given appropriate information that is easy to understand to support their ability to give fully informed consent. The information should also be presented without coercion or unduly influencing a potential participant to enroll in the clinical trial. 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
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 EECBR. The study information sheet should be in Vietnamese.

Documentation Copies
As per DecisionNo799/QD-BYT, 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

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter II (2), Chapter III (6), Chapter V (p.16) (1), 1 - Guidelines Needed for Document List Before Conducting the Clinical Trial, 1.7 and 1.10), 2- Essential Document for the Conduct of a Clinical Trial During the Trial, 2.12 and 2.3), and Annex 6

Informed Consent > Required Elements
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SUMMARY

Overview
As delineated in DecisionNo799/QD-BYT and the C-ClinDrugTrial, prior to beginning a clinical trial, the principal investigator (PI), in conjunction with the host institution, are responsible for submitting to Vietnam’s Ethical Evaluation Committee in Biomedical Research (EECBR) for review and approval the informed consent form (ICF) and any other information being provided to the research participant and/or his/her legal representative(s) or guardian(s).

No Coercion
As per DecisionNo799/QD-BYT, 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 DecisionNo799/QD-BYT and the C-ClinDrugTrial, the ICF should include the following statements or descriptions, as applicable:

  • Description of research with an explanation of its purpose and objectives
  • The expected duration of study
  • Research methods to be followed
  • Inclusion and exclusion criteria for research participants
  • Identify 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, and will not be made publicly available to the extent permitted by applicable laws and/or regulations. If the results are published, the participant’s identity will remain confidential
  • That the EECBR and the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), will be granted direct access to the participant’s original medical records to verify clinical trial procedures and/or data in a manner that will not violate the participant’s confidentiality
  • Compensation and/or medical treatment available to the participant or his/her family or dependents in the event of a trial-related injury
  • The 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
  • That participation is voluntary, the participant may withdraw at any time, and refusal to participate will not involve any penalty or loss of benefits, or reduction in the level of care to which the participant is otherwise entitled
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (6), Chapter V (p.14) (3 and 4), (1- Guidelines Needed for Document List Before Conducting the Clinical Trial, 1.7 and 1.10), and Annex 6

(2) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter IV (Article 15) and Chapter VI (Article 29)

Informed Consent > Compensation Disclosure
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SUMMARY

Overview
In accordance with DecisionNo799/QD-BYT, 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 DecisionNo799/QD-BYT, the ICF should include a statement describing research payments to be made to the participant(s) as compensation for expenditures they incur as a result of participating in the study. No additional information is provided regarding payment for participation in research.

Compensation for Injury
As per DecisionNo799/QD-BYT, 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

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Annex 6

Informed Consent > Participant Rights
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SUMMARY

Overview
In accordance with DecisionNo799/QD-BYT, 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 DecisionNo799/QD-BYT, the participant and/or his/her legal representative(s) or guardian(s) should be informed that participation is voluntary, that he/she may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled.

The Right to Information
As per DecisionNo799/QD-BYT and the C-ClinDrugTrial, 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 DecisionNo799/QD-BYT, 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
DecisionNo799/QD-BYT states that the research participant and/or his/her legal representative(s) or guardian(s) should be provided with contact information for the sponsor and the investigator(s) to address trial-related inquiries and/or his/her rights.

The Right to Safety and Welfare
As set forth in DecisionNo799/QD-BYT, 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

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter II (2), Chapter III (2), and Annex 6

(2) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter VI (Article 29)

Informed Consent > Special Circumstances/Emergencies
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Vulnerable Populations
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SUMMARY

Overview
As per DecisionNo799/QD-BYT and Additional Resource (A), 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. DecisionNo799/QD-BYT and Additional Resource (A) characterize vulnerable populations as those incapable of giving consent, children, pregnant women, people with mental disabilities, people living with HIV/AIDS, indigent groups, people who are illiterate, minorities, 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

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Approval of Protocol, Monitoring and Evaluation, Final Review, and Dissemination of Research and Ethical Aspects of Biomedical Research

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (2) and Chapter V (p.14) (3)

Informed Consent > Children/Minors
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
According to the C-ClinDrugTrial, a minor is someone under 18 years of age.

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

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter III (Article 12)

Informed Consent > Pregnant Women, Fetuses & Neonates
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As per the C-ClinDrugTrial, studies involving women who are pregnant or breastfeeding require additional safeguards to ensure that the research proposal assesses the risks to the women and their infants before the study is conducted.

The C-ClinDrugTrial states that the following conditions must be met when a pregnant or breastfeeding woman is a trial participant:

  • The rationale for selecting this participant shall be provided in the Investigator’s Brochure
  • The study must be initially approved by the Ethical Evaluation Committee in Biomedical Research (EECBR)
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter III (Article 12)

Informed Consent > Prisoners
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Informed Consent > Mentally Impaired
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

Investigational Products > Definition of Investigational Product
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As delineated in the C-ClinDrugTrial, an investigational product (IP) is also referred to as a drug pharmaceutical product, a study drug, and a medicine respectively in the regulatory resources. The C-ClinDrugTrial defines an IP as a drug pharmaceutical product, a medicine, or a study drug containing a new active ingredient or substance, or, a product with a new combination of already marketed pharmaceutical substances. The C-ClinDrugTrial’s definition also includes the following requirements:

  • A pharmaceutical or biologic that has been legally marketed for less than five (5) years in the country of origin
  • A pharmaceutical or biologic for which a clinical trial has been conducted prior to March 20, 2012, but which has not met the Ministry of Health (MOH)’s good clinical practice (GCP) requirements, trial registration standards, or international GCP guidelines recognized by Vietnam
ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter II (Article 5)

Investigational Products > Manufacturing & Import
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As set forth in the PharmLaw, the C-ClinDrugTrial, and DecisionNo799/QD-BYT, the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT), has overall responsibility for authorizing the manufacture of all drug products. According to DecisionNo799/QD-BYT and Additional Resource (A), once the ASTT reviews and the MOH Minister approves the clinical trial dossier, the Drug Administration of Vietnam (DAV), coordinates with the ASTT to review and approve the IP for manufacture or import.

As per the C-ClinDrugTrial, the sponsor is required to provide the following investigational product (IP) documentation in the clinical trial dossier to be submitted to the MOH’s ASTT:

  • Composition, formulation, and manufacturing processes
  • Quality standards
  • Certificate of Analysis (CoA) issued by the National Institute of Drug Quality Control (NIDQC) (Vietnam’s World Health Organization (WHO)-compliant testing agency), or a manufacturer issued Good Manufacturing Practice (GMP) certificate

In addition, IPs which are under review for phase IV clinical trials also require a certified copy of the Certificate of Pharmaceutical Product (CPP) or Free Sale Certificate (FSC), and a GMP certificate from the issuing regulatory authority.

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

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

  • An import order form (forms are referenced in the C-ExprtImprtMeds, but are unavailable in this translation);
  • Cover letter from the leading clinical trial site
  • Copy of study protocol approved by the MOH
  • A CPP (may be substituted with an FSC or GMP certificate) (Note: For multicenter trials, GMP certificates for all manufacturing establishments must be provided)
  • Copy of manufacturer issued CoA
  • 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 information sheet on placebo’s composition, if applicable
  • Donation letter, if applicable


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 C-ExprtImprtMeds-Amdt for applicable forms not provided in the C-ExprtImprtMeds.

ADDITIONAL RESOURCES

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health,  Socialist Republic of Vietnam

Relevant Section: Approval of Protocol, Monitoring and Evaluation, Final Review; Procedures for Manufacture and Import of Medicinal Drugs for Clinical Research

(B) (Document) Medicinal Product Regulation and Product Liability in Vietnam: Overview (Current as of June 1, 2015)
Vu, Hien Thi Thu, Tilleke & Gibbons, Practical Law

Relevant Sections: Regulatory Overview – Regulatory Authorities and Manufacturing

(C) (Website) National Institute of Drug Quality Control (NIDQC) (Vietnamese/Tiếng Việt) (Current as of April 20, 2015)
Ministry of Health, Socialist Republic of Vietnam

(D) (Document) WHO List of Prequalified Quality Control Laboratories (36th Edition) (May 15, 2015)
World Health Organization, Geneva, Switzerland

Relevant Section: Western Pacific Region

REQUIREMENTS

(1) (Legislation) Law on Pharmacy (No: 34/2005/QH11) (PharmLaw – English, unofficial translation) (Vietnamese/Tiếng Việt) (June 14, 2005)
The National Assembly, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Section I, Articles 10 and 11 (3) and Section III)

(2) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (Article 10) and Chapter IV (Article 17)

(3) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter II (2), Chapter V (p.14) (1 and 4), Annex 3, and Process of Approval, Review Dossier for Clinical Trial (chart)

(4) (Regulation) Decision – Promulgating the Regulation on the Import of Drugs Without Registration Number in Vietnam (No. 151/2007/QD-TTBYT) (D-ImprtUnregDrugs – English, unofficial translation) (Vietnamese/Tiếng Việt) (September 12, 2007)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (Articles 1, 2, and 3) and Chapter II (Article 9)

(5) (Regulation) Circular – Guiding the Export, Import of Medicines and Packaging in Direct Contact with Medicines (No. 47/2010/TT-BYT) (C-ExprtImprtMeds – English, unofficial translation) (Vietnamese/Tiếng Việt) (December 29, 2010)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter III (Item II, Articles 11 and 17)

(6) (Regulation) Circular – Amendments and Supplements to a Number of Articles of Circular No. 47/2010/TT-BYT Day 29 Month 12 2010: The Ministry of Health Guidelines for Operation Export, Import, Packaging and Indirect Contact with Drugs (No. 38/2013/TT-BYT) (C-ExprtImprtMeds-Amdt – Vietnamese/Tiếng Việt) (November 15, 2013)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Annex I

Investigational Products > IMP/IND Quality Requirements
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with DecisionNo799/QD-BYT, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB) and for submitting the IB to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT). As per DecisionNo799/QD-BYT, the IB is a concise compilation of clinical and nonclinical data on the investigational product(s) (IPs) relevant to the study of these products in human research participants. This information will enable the principal investigator (PI) and the rest of the study team to understand the benefits and risks involved in the proposed trial. The sponsor should also update the IB as significant new information becomes available.

IB Content Requirements
As specified in DecisionNo799/QD-BYT, the IB must provide coverage of the following areas:

  • Physical, chemical, and pharmaceutical properties and formulation parameters
  • Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
  • Effects of IP in humans (pharmacology, pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; regulatory and post marketing experiences)
  • Summary of data and guidance for the investigator(s)
  • Bibliography

See Annex 2a of the DecisionNo799/QD-BYT for detailed content guidelines.

The C-ClinDrugTrial also provides conditions that must be met to use an IP in a trial:

  • Proven preclinical study results with safety data
  • Documented stable dosage form, formulation, and manufacturing method
  • Quality specifications complying with those registered in trial dossier

See the C-ClinDrugTrial for additional requirements.

As indicated in DecisionNo799/QD-BYT, the sponsor is also accountable for supplying the investigator(s) with the IPs.

Drug Manufacturing Certificate
The C-ClinDrugTrial and DecisionNo799/QD-BYT specify that the sponsor must ensure the IPs are manufactured in a Good Manufacturing Practice (GMP) certified facility and provide a copy of the GMP certificate in the clinical trial dossier submitted to the MOH’s 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

(A) (Document) Implementing Clinical Research In Vietnam: A Dialogue on the Current Regulations of the Ministry of Health (July 12-13, 2007)
Family Health International and Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Approval of Protocol, Monitoring and Evaluation, Final Review; Procedures for Manufacture and Import of Medicinal Drugs for Clinical Research

(B) (Document) Medicinal Product Regulation and Product Liability in Vietnam: Overview (June 1, 2015)
Vu, Hien Thi Thu, Tilleke & Gibbons, Practical Law

Relevant Sections: Regulatory Overview – Regulatory Authorities and Manufacturing

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter II (2), and Chapter III (3 and 4), and Annex 2a

(2) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter II (Article 5) and Chapter III (Article 10)

Investigational Products > Labeling & Packaging
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
Investigational product (IP) labeling in Vietnam must comply with the requirements set forth in the C-ClinDrugTrial and DecisionNo799/QD-BYT.

As set forth in the C-ClinDrugTrial, 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 clinical trial dossier.
(See Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements).

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – Guidelines for Clinical Trials on Drugs (C-ClinDrugTrial – English, unofficial translation) (Vietnamese/Tiếng Việt) (February 2, 2012)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III (Articles 9 and 10) and Chapter V (Article 28)

(2) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter III (3)

Investigational Products > Product Management
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
In accordance with DecisionNo799/QD-BYT, the sponsor is responsible for providing the investigators with an Investigator’s Brochure (IB) and for submitting the IB to the Ministry of Health (MOH)’s Administration of Science, Technology and Training (ASTT), formerly the Department of Science, Technology and Training (DSTT). As per DecisionNo799/QD-BYT, the IB is a concise compilation of clinical and nonclinical data on the investigational product(s) (IPs) relevant to the study of these products in human research participants. This information will enable the principal investigator (PI) and the rest of the study team to understand the benefits and risks involved in the proposed trial. The sponsor should also update the IB as significant new information becomes available.

Investigational Product Supply, Storage, and Handling Requirements
DecisionNo799/QD-BYT states that the sponsor must also supply the investigator(s) with the IPs. As per DecisionNo799/QD-BYT, the sponsor should not supply the IP(s) until he/she obtains approval from the MOH’s ASST and the national EC, the Ethical Evaluation Committee in Biomedical Research (EECBR). As delineated in DecisionNo799/QD-BYT, the sponsor must also ensure the following:

  • IPs manufactured according to good manufacturing practices (GMPs)
  • Proper IP packaging, labeling, and encoding
  • IP product quality and stability
  • Appropriate procedures for revoking and destroying the unused, ruined, and remaining products after completing the clinical trial


Record Requirements
As stated in DecisionNo799/QD-BYT, 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

REQUIREMENTS

(1) (Regulation) Decision on the Issuance of Guideline on Good Clinical Practice (No. 799/QD-BYT) (DecisionNo799/QD-BYT – English, unofficial translation) (Vietnamese/Tiếng Việt) (March 7, 2008)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter I (3), Chapter III (3 and 4), 1-Guidance for Documents Needed on List of Essential Documents Before the Trial Start, 2-Guidance on List of Essential Documents During the Conduct of Clinical Trial, Annex 2a, and Process of Approval, Review Dossier for Clinical Trial (chart)

Specimens > Definition of Specimen
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
In Vietnam, as per the C-MgmtInfectiousSpecs, specimens are defined as human blood, serum, plasma, urine, feces, excreta, and other specimens that contain infectious substances and microorganisms pathogenic to humans. In addition, as per C-MgmtInfectiousSpecs, 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 permanent disability, life-threatening, or fatal diseases in humans when they are exposed (see Annex 1, C-MgmtInfectiousSpecs). Category B specimens are those not listed in Category A.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – On the Management of Infectious Specimens (No. 43/2011/TT-BYT) (C-MgmtInfectiousSpecs – English, unofficial translation) (Vietnamese/Tiếng Việt) (December 5, 2011)
Ministry of Health, Socialist Republic of Vietnam

Relevant Section: Chapter I (Article 2)

Specimens > Import & Export
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

Overview
As set forth in the C-MgmtInfectiousSpecs, the Ministry of Health (MOH)’s General Department of Preventive Medicine (DPM) is responsible for authorizing the import and export of infectious specimens. The applicant should complete the template in Annex 7 of the C-MgmtInfectiousSpecs. Annex 7 requires the applicant to provide:

  • Information on clinical specimens to be imported/exported including types (whether infectious or likely to contain infectious pathogens), origin, quantity, mode of packaging, and transport
  • Importer/exporter commitment to implement strict regulations in storing, transporting, and using clinical samples
  • Contact information for monitoring staff and heads of specimens unit
  • Additional documentation as listed in Chapter III (Article 12)


The C-MgmtInfectiousSpecs also specifies that the following documentation must be included in the dossier:

  • Copy of written approval issued by ministerial or provincial regulatory authority for the research or project
  • Outline of the approved research or project, or, written agreement verifying cooperation between a Vietnamese party and a foreign party relating to the import/export of the specimens
  • Copy of Certificate of Business registration, Establishment Decision, or other papers proving the organization is licensed to export, import, research, preserve, transport, and test specimens
  • Signed contract between the organization licensed to research authorizing another organization to license to import/export specimens, where applicable


As delineated in the C-MgmtInfectiousSpecs, within 10 working days from the day on which a complete and valid dossier is received, the DPM shall issue a written decision to grant or not to grant a license to import/export specimens.

According to an in-country subject matter expert, the DPM is only responsible for approving infectious specimens. In order to obtain a license to import/export non-infectious specimens, the MOH should be contacted to determine the correct department to which an applicant should submit various types of non-infectious samples for testing and approval. Moreover, if the samples are from a clinical trial, then it is recommended that the MOH’s Administration of Science, Technology and Training (ASTT) also be contacted.

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

(1) (Regulation) Circular – On the Management of Infectious Specimens (No. 43/2011/TT-BYT) (C-MgmtInfectiousSpecs – English, unofficial translation) (Vietnamese/Tiếng Việt) (December 5, 2011)
Ministry of Health, Socialist Republic of Vietnam

Relevant Sections: Chapter III and Annex 7

Specimens > Consent for Specimens
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Last content review/update: August 25, 2015. Submit updates or comments.
SUMMARY

No relevant provisions

ADDITIONAL RESOURCES

No additional resources

REQUIREMENTS

No applicable regulatory requirements

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OMB #: 0925-0668
Expiration Date: 2/28/2019