The registration for circulation of traditional medicines within Vietnam is currently guided by comprehensive legal documents. However, to achieve sustainable development and tap into international markets, the traditional pharmaceutical sector needs to focus on exports, especially in the context of deep global integration.
Main Content
- Key Legal Documents
- Priority Policies in Registration
- Traditional Medicines Exempted from Clinical Trials
- Need for Dedicated Mechanism
Traditional medicine represents the crystallization of the nation's wisdom and centuries of experience, playing an important role in healthcare, protection, and the improvement of people's well-being.
Key Legal Documents Related to Traditional Medicine Registration
The amended Law on Pharmacy, which revises and supplements certain provisions of Law No. 105/2016/QH13, was approved by the National Assembly on November 21, 2024. It introduces several policies related to the registration of medicines and pharmaceutical ingredients.
The Ministry of Health has also issued Circular No. 29/2025/TT-BYT dated July 1, 2025, regulating the registration for circulation of traditional medicines, traditional medicinal ingredients, and herbal materials.
Priority Policies in Registration and Circulation
For medicines purchased using state budget funds or other lawful revenues of public healthcare facilities, preferential treatment in purchasing shall be applied to herbal medicines and traditional medicines produced from domestically sourced medicinal materials that meet Good Agricultural and Collection Practices (GACP).
Priority in procedures, processes, and timelines for granting registration certificates shall be given to medicines produced from medicinal materials that comply with GACP, medicines manufactured under nationally approved science and technology projects, and medicines intended for national defense, security, disaster recovery, and epidemic prevention.
A semi-automatic renewal mechanism allows establishments that submit dossiers in accordance with regulations to continue using their registration certificates until renewal is granted or until the receiving authority issues a notice of non-renewal.
Traditional Medicines Exempted from Clinical Trials
Traditional medicines exempted from clinical trials are classified into three groups: formulas recorded in the works of Hải Thượng Lãn Ông and Tuệ Tĩnh, formulas included in the Vietnamese Pharmacopoeia or the pharmacopoeias of China, Japan, or Korea, and family remedies that have been granted a certificate of traditional formula.
Vietnam is known for its two great physicians, Hải Thượng Lãn Ông and Tuệ Tĩnh, regarded as the founders of Vietnamese traditional medicine. Notably, Hải Thượng Lãn Ông was honored by UNESCO as a World Cultural Celebrity.
The Need for a Dedicated Mechanism
Current regulations and guidelines on traditional medicines remain scattered across the Law on Pharmacy and various circulars and general provisions. This fragmentation creates difficulties and confusion for individuals, organizations, and businesses involved in traditional medicine.
To fully harness the essence of Vietnamese traditional medicine, it is necessary to establish a specialized legal framework for traditional medicines and promptly enact a dedicated Law on Traditional Medicine and Pharmacy with specific policies and regulations.
Improving regulations on the registration and circulation of traditional medicines is not only a state management task but also a strategic step to preserve and promote the heritage of Vietnamese traditional medicine.
(Source: suckhoedoisong.vn)