On July 18. 2024, Vietnam’s Ministry of Health issued Circular No. 12/2024/TT-BYT promulgating National Technical Regulation QCVN 20-1:2024/BYT on the limits of contaminants for health supplements (“Circular 12”). The new national technical regulation is the very first relating to health supplements, and is expected to have a great impact on the control of health supplement quality in Vietnam. Circular 12 will take effect on August 1, 2025. Contents of Circular 12 The new circular prescribes limits of contaminants (heavy metals and microorganisms), testing samples and testing methods, management requirements, and responsibilities of entities manufacturing and trading in health supplements. Supplemented alcohol products which are declared as health supplements are notably excluded from the scope of the regulation. Transitional Provisions Health supplements which (i) have been granted a declaration registration certificate, and (ii) are manufactured before August 1, 2025, are allowed to continue to be imported, traded, and circulated until the expiry date of the product, even if it is not aligned with Circular 12, except when there is food safety warning. Declaration registration dossiers for health supplements submitted before August 1, 2025, will continue to be handled in accordance with the prevailing regulations at the time of submission. From August 1, 2025, if a health supplement with a granted declaration registration certificate has a manufacturer’s standard that does not comply with Circular 12, the party manufacturing/trading in the product must adjust the product standard to conform to Circular 12 and notify the authority of this adjustment.

Thailand’s Minister of Public Health recently promulgated the Ministerial Notification Re: Category 5 Narcotics Which Are Not Cannabis or Hemp Extract and Whose Consumption is Permitted for Treatment of Disease or for Research Purposes (2024). The notification took effect on April 23, 2024. The substances whose regulatory controls are affected by this new notification are psilocybin mushroom (Psilocybe cubensis (Earle) Singer), opium poppy (Papaver somniferum L. and Papaver bracteatum Lindl.), and other plants in these genera from which opium, opium alkaloids, psilocybin, or psilocin may be derived. As a result of this notification, these substances are now classified as category 5 narcotics that can be applied in medical treatment. Without the implementation of this notification, patients could not access newly developed medicines containing these substances, as Thailand’s Narcotic Code prohibits the possession and use of category 5 narcotics. Nonetheless, this does not mean that psilocybin mushrooms and opium can be used without any conditions. There is still a long process to go through before these substances can be used in medical treatment or clinical studies. Under the new notification, the FDA must first approve any medicinal drug formulation containing any of the above substances, and subsequently, the production must be approved for medical use or research purposes. The importation of medicinal drug formulations containing psilocybin mushrooms or opium is not allowed. This seemingly small regulatory change addresses the previous legal obstacle to the research and development of such medicines. According to the previous regulation, a physician or researcher could apply to the Thai FDA for a license to produce or possess medicines containing the aforementioned narcotics. However, production and consumption are considered different activities, and consuming a narcotic-containing medicine, even if it was produced under a valid license, is prohibited by the Narcotics Code and is punishable by imprisonment,

Advances in biotechnology have enabled the development of a range of new agricultural tools. From DNA sequencing to plant tissue culture and gene editing, these advances are facilitating the development of better crops. Genetically modified organisms (GMOs) are one well-known example of agricultural biotechnology. GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA. This DNA may be synthetic in origin or sourced from other organisms. Genome editing (also called gene editing or GEd) involves making precise changes to an organism’s genome without the integration of foreign DNA elements. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, in which scientists make precise “cuts” in the DNA to create a new genetic variation. Unlike with GMOs, this introduces only minor modifications that are indistinguishable from natural mutations, typically by transplanting genes that code desirable traits from one species into another. GEd technology has been recognized and supported by the Food and Agriculture Organization of the United Nations (FAO). Thirteen FAO-member countries who are also members of the Organization for Economic Cooperation and Development (OECD) announced their support of the use of GEd technology for commercial uses and consumption at a recent WTO meeting. In addition, over 40 countries around the world, such as Argentina, Australia, Brazil, Canada, Chile, China, England, Japan, Kenya, the Philippines, Russia, the UK, and the US, have published policies emphasizing that foods free of transgenes (i.e., foods that do not contain genes transferred from external sources) are not GMOs, concluding that GEd plants are as safe as normal plants. In February 2024, the European Parliament approved new genomic techniques (NGTs), or GEd. As a result, plants that are produced using GEd technology are not classified by the EU as GMOs, and the EU

Thailand is preparing to implement new rules on drug importation for clinical studies. The Medicines Regulation Department of Thailand’s Food and Drug Administration (Thai FDA) first issued the Notification Re. Detailed Requirements for Drug Importation into Thailand for Clinical Studies almost a year ago, and the notification is expected to come into effect on March 1, 2024. Key Provisions The notification aims at enhancing the efficiency of conducting clinical studies while ensuring the protection of human subjects participating in such studies within Thailand. Some of its key provisions include: Definition of Clinical Study. The notification defines a “clinical study” as a study of a medicine involving human subjects, conducted to provide supporting evidence for the registration of a medicinal product in Thailand or other countries, including for additional indications or variations of a registration dossier. Compliance with ICH GCP. Clinical studies conducted in Thailand must adhere to the current edition of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines. Clinical Trial Application. Sponsors are required to submit a clinical trial application along with supporting documents to the Thai FDA for approval before commencing a clinical study. The permit remains valid for five years and is renewable. Supply of Investigational Drugs. Sponsors must obtain investigational drugs from manufacturers compliant with Good Manufacturing Practice (GMP) standards as recognized by the Thai FDA. Postapproval Obligations. The secretary-general of the Thai FDA may impose postapproval conditions or order investigators to conduct or suspend certain activities to ensure human subject protection and regulatory compliance. Regulatory Oversight. The Thai FDA is responsible for inspecting and overseeing the regulatory compliance of clinical studies, including during prestudy, ongoing, and poststudy phases. The Thai FDA may also conduct inspections of clinical studies conducted overseas. The Thai FDA