THE MINISTRY OF PUBLIC HEALTH
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No: 01/2007/QD-BYT
Hanoi, January 11, 2007
 
DECISION
PROMULGATING THE REGULATION ON CLINICAL TRIALS OF MEDICINES
THE MINISTER OF HEALTH
Pursuant to June 14, 2005 Law No. 34/2005/QH11 on Pharmacy;
Pursuant to the Government's Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
At the proposal of the director of the Department of Science and Training, the director of the
Vietnam Drug Administration and the director of the Legal Department,
DECIDES:
Article 1.- To promulgate together with this Decision the Regulation on clinical trials of medicines.
Article 2.- This Decision takes effect 15 days after its publication in "CONG BAO". To annul the Health Minister's Decision No. 186/BYT-QD of May 6, 1975, on the Regulation on trial researches into clinical treatment, and instructions on clinical studies of traditional medicines in the Regulation on evaluation of safety and efficacy of traditional medicines promulgated together with the Health Minister's Decision No. 371/BYT-QD of March 12, 1996, and the Guidelines on the technical process of clinical trials of medicines issued together with Official Letter No. 505/BYT-K2DT of January 24, 2006.
Article 3.- The director of the Office, the Chief Inspector and directors of Departments under the Ministry of Health, directors of provincial/municipal Health Services, heads of health agencies in all branches and heads of units attached to the Ministry of Health shall implement this Decision.
 
 
MINISTER OF HEALTH


Tran Thi Trung Chien
 
REGULATION
ON CLINICAL TRIALS OF MEDICINES
(Promulgated together with the Health Minister's Decision No. 01/2007/QD-BYT of January 11, 2007)
Chapter I
GENERAL PROVISIONS
Article 1.- Scope of regulation
1. This Regulation provides for medicines subject to clinical trial, medicines exempt from clinical trial and medicines exempt from some phases of clinical trial in Vietnam, including finished medicines, pharmaceutical chemicals, pharmaceutical materials, vaccines and medical biological products (hereinafter collectively referred to as medicines).
2. Medicines subject to clinical trial, medicines exempt from clinical trial, and medicines exempt from some phases of clinical trial include:
a/ Medicines subject to clinical trial:
- Medicines containing a newly invented substance.
- Medicines containing a new combination of pharmaceutical substances already marketed.
- Vaccines and medical bio-products used for the first time in Vietnam.
b/ Medicines exempt from clinical trial:
- Generic medicines.
- Foreign medicines which have not yet granted a registration number for circulation in Vietnam but have been lawfully marketed for at least five years in the country of origin; have been widely used for many patients and have been certified by a competent state agency in the country of origin to be safe and efficacious; and have the same route of usage, content and use indications in Vietnam as in the country of origin.
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