On November 22, 2024, the Ministry of Health (MOH) in Laos issued Decision No. 3730/MOH, which regulates the management, processing, production, and use of biopharmaceutical products, genes, and stem cells. This decision came into force on January 18, 2025, 45 days after its publication in the Lao Official Gazette on December 4, 2024. This decision signifies Laos’ recognition and acceptance of biopharmaceutical products, genes, and stem cells for use in medical treatments and the beauty industry, and it aligns with the ongoing development of biomedical sciences in the country. Definitions The MOH’s decision defines biopharmaceuticals, gene therapy, and stem cells as follows: “Biopharmaceutical products” refers to a type of biological or drug product that is produced or synthesized from natural substances, objects, or chemicals. This group of products includes blood, blood components, allergens, cells or cellular components, gene therapies, tissues, protein-based medicines, drugs derived from living cells, and biologics, which can be produced from sugars, proteins, amino acids, or substances with complex characteristics derived from organic sources such as human, animal, and plant parts; yeast; and microorganisms. These products exclude vaccines and biosimilar products, which will be specified under separate regulations. “Gene therapy” refers to a treatment approach that applies the principle of arranging amino acids (which could involve DNA or RNA sent to the patient’s cells in the form of a drug with the purpose of treating a certain disease). “Stem cells” are defined in the decision as cells or immature cells that can be sourced from various organs in the They are characterized by being undifferentiated, having the potential for differentiation, and being self-renewing. Stem Cell Production The decision outlines comprehensive provisions for managing and using raw materials in stem cell production. Key points include: Production location standards: Ensuring facilities meet specific standards of the MOH. Personnel