Chapter XI
CLINICAL TRIAL AND BIOEQUIVALENCE STUDY
Section 1. Clinical trial
Article 86. Phases of clinical trial
1. Phase 1 is the first phase of testing in humans to make a preliminary assessment of drug safety.
2. Phase 2 is meant to determine the optimal dose for clinical trial and prove the safety and efficacy of the drug, including the ability of the vaccine to stimulate development of immunity in users.
3. Phase 3 is carried out on large scale to determine the stability of the formula, the overall safety and efficacy of the drug, or to assess the protective effect and safety of vaccine in users.
4. Phase 4 is carried out after the drug is permitted for free sale in order to keep assessing its safety and efficacy or monitor the protective effect of the vaccine after it is widely used under prescribed conditions.
Article 87. Clinical trial for drug registration
1. Phase 1, 2, and 3 shall be carried out before drug registration
2. Phase 4 shall be carried out after drug registration at the request of a competent pharmacy authority.
Article 88. Requirements applied to drugs undergoing clinical trial
1. A drug undergoing clinical trial must satisfy the following conditions:
a) It has undergone pre-clinical trial;
b) It has a stable dosage form;
c) It meets quality standards according to the application for clinical trial.
2. On the label of the drug used for clinical trial must have the text “Thuốc dùng cho thử lâm sàng. Cấm dùng cho Mục đích khác” (“For clinical trial only”).
Article 89. Drugs required to undergo clinical trial and drugs exempt from clinical trials
1. The following drugs must undergo all phases of clinical trial:
a) New drugs, except for the cases specified in Point a Clause 2 and Point b Clause 3 of this Article;
b) Herbal drugs with new combination of herbal ingredients that were medicinally used in Vietnam and meant to treat diseases on the List promulgated by the Minister of Health, except for the cases specified in Point b Clause 2 and Point c Clause 3 of this Article;
c) Vaccines registered in Vietnam for the first time, except for the case specified in Point c Clause 2 of this Article.
2. The following drugs are exempt from certain phases of clinical trial:
a) Any new drug granted a certificate of free sale in at least a country but clinical data about its safety and efficacy is insufficient;
b) Any herbal ingredients other than those specified in Point c Clause 3 of this Article;
c) Any vaccine granted a certificate of free sale in at least a country and there is clinical data about its safety and efficacy.
3. The following drugs are fully exempt from clinical trial:
a) Generic drugs;
b) Any new drug granted a certificate of free sale in at least a country and there is clinical data about its safety and efficacy, except for vaccines;
c) Any herbal drug granted a certificate of free sale before the effective date of this Law, except for the drugs used for treatment of diseases on the List promulgated by the Minister of Health.
4. The Minister of Health shall provide for clinical data about drug safety and efficacy, criteria for partial or full exemption from clinical trial in Vietnam, and drugs required to undergo phase 4 of clinical trial.
Article 90. Conditions for a person to participate in clinical trial
1. The clinical trial subject must be a volunteer who satisfy clinical trial requirements, signs an agreement on voluntary participation in the clinical trial with the provider of clinical trial services, except for people who have limited legal capacity or have no legal capacity.
2. If a clinical trial subject is a minor, has limited legal capacity or has no legal capacity, it is required to have his/her guardian’s consent as prescribed by law.
3. If a clinical trial subject is a pregnant woman, the trial documents must specify the reasons and measures shall be taken to protect her.
Article 91. Rights and obligations of clinical trial subjects
1. A clinical trial subject has the rights to:
a) Be adequately and truthfully informed of the risks before the clinical trial;
b) Receive compensation from the sponsor for any harm incurred;
c) Have relevant personal information kept confidential;
d) Take no responsibility when unilaterally terminate the participation in the clinical trial;
dd) File a complaint or lawsuit against any illegal acts committed by the sponsor and the clinical trial service provider (hereinafter referred to as the investigator).
2. Clinical trial subjects have the responsibility to comply with instructions of researchers according to approved clinical trial documents.
Article 92. Rights and obligations of the sponsor
1. The sponsor has the rights to:
a) Select a qualified organization in terms of equipment and personnel to run the clinical trial;
b) Acquire the full ownership of the clinical trial result.
2. The sponsor has the obligations to:
a) Pay compensation to clinical trial subjects for any harm they incur because of the clinical trial as prescribed by law;
b) Sign a clinical trial contract with the investigator;
c) Take legal responsibility for the quality and safety of the drug provided.
Article 93. Rights and obligations of the investigator
1. The investigator has the rights to:
a) Carry out clinical trials of drugs as prescribed;
b) Import, purchase chemicals, reference materials, and drug samples serving clinical trials;
c) Use clinical trial results under agreements with the sponsors.
2. The investigator has the obligations to:
a) Take responsibility for the clinical trial results;
b) Take responsibility for the safety of clinical trial subjects and pay compensation for those who suffer injuries for which the investigator is responsible;
c) Ensure truthfulness and objectivity in clinical trials;
d) Be independent in terms of finance and personnel from the sponsors.
Article 94. Principles and the power to approve clinical trial services
1. A clinical trial may only be carried out after a National Biomedical Ethics Committee assesses its scientificity and ethical aspects according to clinical trial documents and the Minister of Health grants an approval in writing.
2. The clinical trial, the assessment of its scientificity and ethical aspects and the grant of approval for a clinical trial shall comply with the following principles:
a) Respect the right of decision of clinical trial subjects; protect people whose right of decision is limited;
b) Ensure that the trial offers more benefits than risks; the risks are carefully considered and minimized according to standards;
c) Ensure that rights and obligations of clinical trial subjects are equal; benefits and risks are equally shared among the clinical trial subjects;
d) Ensure the completion of clinical trial phases and fulfillment of Good Clinical Practice requirements.
3. Biomedical Ethics Committees are independent national and internal committees established to protect the rights, safety, and health of clinical trial subjects.
The Minister of Health shall provide for the establishment, functions, tasks, and entitlements of Biomedical Ethics Committees.
Article 95. Documentation and procedures for carrying out clinical trials
1. Documents about a clinical trial include:
a) An application for permission for clinical trial;
b) Documents containing information about the drug;
c) Legal documents about the drug;
b) The clinical trial outlines and description;
dd) Academic records of researchers;
e) Registration forms of clinical trial subjects;
g) Record on scientific and ethical assessment prepared by the internal Biomedical Ethics Committee;
h) Label of the drug.
2. Clinical trial procedures:
a) Register the clinical trial;
b) Approve the clinical trial;
c) Conduct the clinical trial;
d) Approve the clinical trial result.
3. The Minister of Health shall elaborate this Article.
Section 2. BIOEQUIVALENCE STUDY
Article 96. Phases of bioequivalence study and drugs required to undergo bioequivalence study
1. A bioequivalence study consists of the following phases:
a) Clinical trial phase: a phase in which a comparative drug and a the tested drug which is proven safe and effective are tested to compare their bioavailability in the subjects;
b) Human biological fluid analysis: a phase in which concentrations of a comparative drug and a the tested drug in specimens of the subjects are analyzed in order to compare their bioavailability and prove their bioequivalence;
2. A generic drug must undergo bioequivalence study if it contains an active ingredient or has a dosage form that is on the List of active ingredients and dosage forms required to undergo bioequivalence studies promulgated by the Minister of Health.
Article 97. Conditions, rights and obligations of subjects of bioequivalence studies
1. Every subject of a bioequivalence must satisfy the conditions specified in Article 90 hereof.
2. Rights and obligations of the subjects are the same as those specified in Article 91 hereof.
Article 98. Rights and obligations of the sponsor
1. The sponsor has the rights to:
a) Select a qualified organization in terms of equipment and personnel to run the bioequivalence study;
b) Acquire the full ownership of the bioequivalence study result.
2. The sponsor has the obligations to:
a) Pay compensation for the subjects who suffer injuries because of the bioequivalence study;
b) Sign a bioequivalence study contract with the investigator;
c) Take legal responsibility for the quality and safety of the drug provided.
Article 99. Rights and obligations of the investigator
1. The investigator has rights to:
a) Carry out clinical trial and biological fluid analysis in bioequivalence testing.
If only biological fluid analysis is carried out, it may sign a contract or cooperate with a provider of clinical trial services that fulfills Good Clinical Practice requirements to carry out clinical trial in the process of bioequivalence study;
b) Conduct bioequivalence studies as prescribed;
c) Import, purchase chemicals, reference materials, and drug samples serving bioequivalence studies;
d) Use bioequivalence study results under agreements with the sponsors.
2. The investigator has obligations to:
a) Take responsibility for the bioequivalence study results;
b) Take responsibility for the safety of subjects and pay compensation for those who suffer injuries for which the investigator is responsible;
c) Ensure truthfulness and objectivity in bioequivalence studies;
d) Be independent in terms of finance and personnel from the sponsors.
Article 100. Rules for approving bioequivalence studies
1. The bioequivalence study may only be conducted after the internal Biomedical Ethics Committee assesses the scientificness and ethics of the bioequivalence study documents and the person in charge of expertise of the investigator grants a written approval.
2. The bioequivalence study shall comply with the following principles:
a) The principles specified in Point a, b, c of Clause 2 Article 94 hereof;
b) Fulfillment of Good Clinical Practice and Good Laboratory Practice requirements in biological fluid analysis, and compliance with guidelines on bioequivalence studies promulgated by the Minister of Health.
3. The internal Biomedical Ethics Committee shall assess the scientificness and ethics of the bioequivalence study documents and approve the study outlines.
Article 101. Documentation and procedures for bioequivalence studies
1. Bioequivalence study documents include:
a) An application for permission for bioequivalence study;
b) Documents containing information about the drug;
c) The bioequivalence study outlines and description;
d) Academic records of researchers;
dd) Registration forms of the subjects;
e) Drug label.
2. Procedures for bioequivalence study:
a) Register the bioequivalence study;
b) Approve the bioequivalence study;
c) Conduct the bioequivalence study;
d) Approve the bioequivalence study result;
3. The Minister of Health shall elaborate this Article.
Tìm kiếm
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