Cambodia’s Law on Food Safety came into force on June 8, 2022. This law has been widely regarded as a major legal development of the food safety framework in Cambodia, providing new rules, clarifying existing rules, and setting a clear framework for its implementation and enforcement. In addressing some of the key features of this new law shortly after it was passed in 2022, we remarked that we eagerly await implementing regulations. Since then, various regulations have been adopted, such as two regulations (Sub-Decree No. 13 and Prakas No. 80) on food surveillance, recalls, and seizure. These implementing rules are essential in ensuring that enforcement officers can remove noncompliant and unsafe foods from the market. Another key aspect of the Law on Food Safety is that it requires Khmer-language labeling on prepackaged food products. There has been a notable increase in the inclusion of Khmer labeling on food products in the market since June 2022, but noncompliance is still considerable, especially for imported foods. Further interesting labeling rules set by the Law on Food Safety include a requirement to provide nutrition information. This requirement has not yet been widely adopted, with many in the industry highlighting that the details of this labeling requirement are not clear. Indeed, the relevant article of the Law on Food Safety itself only sets the requirement for food products to bear nutrition labeling and does not spell out what detailed information should be provided or in what manner. However, a prakas (ministerial regulation) adopted months prior to the Law on Food Safety does set out clear guidance on nutrition labeling. As long as this earlier regulation is not replaced or abrogated, and as far as it does not conflict with later laws or regulations, it can be relied upon for guidance. What are the

Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.

In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic. During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19. As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023. Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease. Distribution The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products: Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization

Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products. There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following: Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc. Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc. Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc. The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims. Tips on Health Claims for Health Supplements 1. Nutritional Claims For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the