Nghiên cứu được thực hiện với mong muốn mang đến cái nhìn tổng quát về thực trạng đăng ký thuốc tại Việt Nam giai đoạn 2009-2019. Phân loại “Thuốc” theo định nghĩa Luật Dược số 105/2016/QH13. Thuốc hóa dược, sinh phẩm phân thành 27 nhóm theo mã ATC dựa trên thông tư 30/2018/TT-BYT và Vaccine. 19 nhóm dạng bào chế phân theo Dược điển Việt Nam V. Giai đoạn 2009-2019, Việt Nam có số đăng ký thuốc được cấp. | VNU Journal of Science Medical and Pharmaceutical Sciences Vol. 37 No. 2 2021 50-69 Original Article Situation Analysis of the Drug Registration in Vietnam from 2009 To 2019 Nguyen Thi Hai Yen Thai Hue Ngan University of Medicine and Pharmacy at Ho Chi Minh City 41 Dinh Tien Hoang Ben Nghe Ward District 1 Hochiminh City Vietnam Received 11 March 2021 Revised 22 March 2021 Accepted 31 March 2021 Abstract Vietnam is classified into the group of emerging pharmaceutical countries Pharmerging according to the classification of IMS Health since 2008. In order to achieve the potential it is necessary to have a clear understanding of the status of drugs registered for circulation in Viet Nam. However research on this issue has not been popular lacked updating and has not shown continuous change over a long period of time. Therefore the study is conducted with the desire to provide an overview of the status of drug registration in Vietnam in the period 2009-2019. Classify quot Drugs quot according to the Law on Pharmacy No. 105 2016 QH13. Pharmaceutical and biological drugs are classified into 27 groups according to ATC codes based on Circular 30 2018 TT-BYT and Vaccine. 19 groups of dosage forms classified according to the Vietnam Pharmacopoeia V. In the period 2009-2019 Vietnam has 45 801 registered drug registration numbers. In which domestic drugs with 28 388 numbers 62 . India and South Korea are the 2 countries with the most number of registrations accounting for and respectively. Chemico-pharmaceutical finished products registered with 42 245 numbers . The group of drugs for treating parasites and anti- infections is the most registered with . Oral and parenteral administration infusion are the two main forms of administration of which tablets are the most registered dosage form accounting for . Paracetamol is the most registered active ingredient with a total of 2262 registration numbers. Drugs produced domestically have partly met the .
