Chapter I
GENERAL PROVISIONS
Article 1. Scope of governing
This Circular guides on the drugs required to be conducted clinical trial, exempted from clinical trial, exempted from some stages of clinical trial, conditions of clinical drugs trial; registration, evaluation and approval of clinical drugs trial, the clinical drug trial stages, rights and obligations of the stakeholders; supervision, inspection, acceptance and evaluation of clinical drug trial in Vietnam for the study, permission of the circulation of pharmaceutical drugs, medical biological products, vaccines and traditional medicines or drugs from medicinal plants used in the diagnosis, treatment and disease prevention directly on human (hereinafter referred to as drugs).
Article 2. Interpretation of terms
In this Circular, the following terms are construed as follows:
1. A reference country means one of the countries as UK, France, Germany, USA, Japan, Australia, Canada or management bodies of medical products in Europe (European Medicines Agency - EMA).
2. Multi-center research means a clinical trial which is conducted in two or more research centers to ensure the universality of the number of participants in clinical drug trial, more diversity of elements of demography, anthropology.
3. Agencies, organizations and individuals having drugs required to be conducted clinical trial mean the agencies, organizations and individuals that undertake research, production, import, export, distribution of drugs wishing for their drugs to be conducted clinical trial.
4. Organizations undertaking clinical drug trial mean the health facility with function of science research that are eligible for professional personnel, material facilities, equipment for conducting clinical drug trial and to be evaluated, permitted by the Health Ministry.
5. Participants in the clinical drug trial mean patients or healthy volunteers participating voluntarily in the research.
6. Clinical Research Organization (Contract Research Organization: CRO) means an organization with legal entity status, professional capacity in accordance with the provisions of the Health Ministry, independent of agencies, organizations and individuals with drugs of clinical trial, contracted with organizations, individuals with drugs of clinical trial to perform the works of research support such as writing research outline, research monitoring, data analysis.
7. Management organization of research sites (Site Management Organization: SMO) means an organization with legal entity status, full capacity in accordance with provisions of the Ministry of Health, independent of agencies, organizations and individuals with drugs of clinical trial, organizations undertaking clinical drugs trial, contracted with organizations, individuals with drugs of clinical trial or organizations undertaking clinical drug trial to perform the works of supporting the research site management .
8. Foreign clinical data means the method and results of clinical research which have been done abroad.
9. Racial factors mean the factors related to group of large populations with common genetic characteristics, culture, traditions, and environment.
10. The international regulations for clinical drug trial accredited by the Health Ministry means good clinical practice guidelines of the blocks of regions located in the meeting of international harmonization of pharmaceutical use in humans (ICH) and good clinical practice guidelines (Good Clinical Practice - GCP) of the World Health Organization (WHO).
Article 3. Principles of clinical drugs trial
1. The clinical drug trial must comply with the provisions of this Circular, the provisions of law on science and technology, good clinical practice and the international treaties to which Vietnam is a member.
2. Participants in clinical drug trial must be selected in accordance with the principles of ethics in biomedical research.
Article 4. Prohibited Acts
1. Conduct clinical drug trial without permission of the Ministry of Health.
2. Arbitrarily amend or supplement records, research outline which were approved by the Health Ministry.
3. Using drugs in clinical trial for other purposes.
4. Force subjects to participate in research or hide information or fail to provide for information prescribed for research participants.
Tìm kiếm
Thông tư 03/2012/TT-BYT (Bản Word)