Analysis of Registration Situations of Drugs from Medicinal Materials and Traditional Medicines in Vietnam Period 2009-2020

Vietnam not only has a long history in traditional medicines but also has a diversity of medicinal plants to this day. Therefore, since 2016, the Government has introduced that the production of available medicinal materials was prioritized field in the development of pharmaceutical industry. However, until now, there is still little research related to drugs from medicinal materials and traditional medicines in our country, so we conducted this research to provide an overview of the registration situation of this drug group in Vietnam throughout the period 2009-2020. The results showed that in 12 years, drugs from medicinal materials and traditional medicines had had 2985 registration numbers, accounting for 6.9% of all registered drugs. Among 11 effect groups based on traditional medicines, the group of heat-clearing, detoxifying, dispelling rashes, and diuresis ranked first with 21.0%. Domestic drugs accounted for a large amount, with 2814 numbers (94.3%). Capsules and tablets were the two dosage forms with the highest number, holding 54.6%. In terms of drug components of registered traditional medicines, there were 87 products in single-component form and more than 1200 products in combination form. Our country had 224 manufacturers of this drug group, and 81 of them achieved GMP. In general, the registration of drugs from medicinal materials and traditional medicines met the guidelines set out by the Government, and manufactured drugs were qualified to serve the needs of people. However, in order to develop the field of drugs from medicinal materials and traditional medicines like other countries in Southeast Asia, in the coming years, Vietnam needs more support from the state management agencies and research efforts from pharmaceutical companies. Keywords: Registration number, Drugs from medicinal materials, Traditional medicines, Vietnam. References [1] The Government, Resolution No. 226-CP Regarding the Development of Traditional Ethnic Medicine in Close Combination with Modern Medicine, in Order to Build Vietnamese Medicine, Hanoi, 1978 (in Vietnamese).[2] The Government, Resolution No. 37-CP Strategic Orientation of People's Health Care and Protection in the Period 1996-2000 and Vietnam's National Drug Policy, Hanoi, 1996 (in Vietnamese).[3] The National Asembly, Law of Pharmacy, No. 105/2016/QH13, Hanoi, 2016 (in Vietnamese).[4] N. H. Trang, Analyzing and Evaluating the Group of Registered Traditional Medicines for Circulation in Vietnam Until 2006, Department of Pharmacoeconomics and Management, Hanoi University of Pharmacy, 2006 (in Vietnamese).[5] N. T. H. Yen, T. H. Ngan, VNU Journal of Science: Situation Analysis of the Drug Registration in Vietnam from 2009 to 2019, Vol. 37, No. 2, 2021, pp. 2, https://doi.org/10.25073/2588-1132/vnumps 4297 (in Vietnamese).[6] World Health Organization, Regional Office for South-East Asia, Access to Medical Products in the South-East Asia Region 2019: Review of Progress, https://apps.who.int/iris/handle/10665/32682, 2019 (accessed on: March 27th, 2021).[7] Ministry of Health, Health Statistics Yearbook 2018, Medical Publshing House, Hanoi, 2018 (in Vietnamese).[8] The Prime Minister, Decision No. 1893/QD-Ttg Issuing the Program of Developing Traditional Medicine, Combining Traditional Medicine with Modern Medicine by 2030, Hanoi, 2019 (in Vietnamese).[9] The Prime Minister, Decision No. 68/QD-Ttg Approving the National Strategy on Development of the Vietnam Pharmaceutical Industry up to 2020, with A Vision Toward 2030, Hanoi, 2014 (in Vietnamese).[10] Drug Administration of Vietnam, List of Manufacturers of Drugs and Drug Materials in Vietnam that Satisfy the GMP Standards, https://dav.gov.vn/danh-sach-cssx-thuoc-nguyen-lieu-lam-thuoc-tai-vn-dap-ung-tieu-chuan-gmp-cap-nhat-den-ngay-0892020-n2930.html/, 2020 (accessed on: September 25th, 2020) (in Vietnamese).[11] Ministry of Health, Decision No. 3657/QD-BYT Issuing the List of 100 Medicinal Materials with High Medical and Economic Values to Focus on Development in 2020-2030, Hanoi, 2019 (in Vietnamese).[12] Ministry of Health, Circular No.19/2018/TT-BYT Introducing List of Essential Medicines, Hanoi, 2018 (in Vietnamese).[13] Ministry of Health, Circular No.05/2015/TT-BYT Promulgation of List of Oriental Medicines, Herbal Medicines and Traditional Ingredients Covered by Health Insurance, Hanoi, 2015 (in Vietnamese).[14] N. V. Cuong, Pharmaceutical Industry Update Report April 2020, http://www.fpts.com.vn/FileStore2/File/2020/04/10/Pharmaceutical_Update_Report_Apr2020_108753a8.pdf/, 2020 (accessed on: March 20th, 2021) (in Vietnamese).[15] Traphaco Joint Stock Company, Annual Report 2020, http://traphaco.com.vn/upload/files/20210322_TRA_AR2020%20-%20kyduyet%20(1).pdf/, 2020 (accessed on March 20th, 2021) (in Vietnamese).[16] The Prime Minister, Decision No. 1976/QD-Ttg Approving the Master Plan on Medicinal Plant Development Through 2020, with Orientations Toward 2030, Hanoi, 2013 (in Vietnamese).