Decision No. 01/2007/QD-BYT promulgates regulations on clinical drug trials applicable to healthcare facilities and research units. These regulations replace some old documents.
适用范围
Healthcare facilities, research units, and pharmaceutical management.
要点
- Healthcare facilities and research units → conduct clinical drug trials according to the new regulations.
- Effective date → The Decision takes effect fifteen days from the date of publication in the Official Gazette.
- Old regulations → Abolish Decisions No. 186/BYT-QĐ (1975), No. 371/BYT-QĐ (1996), and Circular No. 505/BYT-K2ĐT (2006).
- Responsibility for implementation → Ministries, agencies, and units under the Ministry of Health and Provincial Health Departments are responsible.
🌐 本文件的社会影响
- Positive impact: Enhance quality control of drugs in the market through clinical trials.
- Negative impact: May cause difficulties for new research and trial processes.
❓ 常见问题
When does this Decision take effect?
The Decision takes effect fifteen days from the date of publication in the Official Gazette.
What are the old regulations being abolished?
Abolish Decision No. 186/BYT-QĐ (1975), Decision No. 371/BYT-QĐ (1996), and Circular No. 505/BYT-K2ĐT (2006).
What must healthcare facilities implement according to the new regulations?
Healthcare facilities conduct clinical drug trials according to the newly issued Regulations on Clinical Drug Trials.
What is the effective period of this Decision?
The Decision takes effect fifteen days from the date of publication in the Official Gazette, without specifying a specific duration.
Which agencies are responsible for implementing this Decision?
The Director of the Office, the Inspector General, Department Heads under the Ministry of Health, Bureau Chiefs under the Ministry of Health, Directors of Provincial Health Departments, Chief Health Officers of sectors, and Heads of units directly under the Ministry of Health are responsible for implementation.
全文
Pursuant to …;
Regarding the issuance of "Regulations on Clinical Drug Trials"
____________________________
THE MINISTER OF HEALTH
Pursuant to the Medicine Law No. 34/2005-QH11 dated June 14, 2005;
Pursuant to the Government Decree No. 49/2003/NĐ-CP dated May 15, 2003 stipulating 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 General of the Vietnam National Medicines Administration, and the Director of the Legal Affairs Department.
Pursuant to …;:
Article 1The "Regulations on Clinical Drug Trials" are hereby promulgated together with this Decision.
Article 2This Decision shall take effect fifteen days from the date of publication in the Official Gazette. The Decision No. 186/BYT-QĐ dated May 6, 1975 of the Minister of Health regarding the Clinical Treatment Research Regulations, Guidelines for Traditional Medicine Clinical Research within the content of the "Traditional Medicine Drug Safety and Efficacy Evaluation Regulations" issued pursuant to Decision No. 371/BYT-QĐ dated March 12, 1996 of the Minister of Health, and the Technical Procedures for Clinical Drug Trials attached to Circular No. 505/BYT-K2ĐT dated January 24, 2006 of the Ministry of Health are hereby repealed.
Article 3The Heads of the Office, Inspectorate, Directors of Departments under the Ministry of Health, Directors of General Departments under the Ministry of Health, Provincial Health Departments, Health Sector Chiefs, and Heads of Units directly under the Ministry of Health are responsible for implementing this Decision./.
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