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

Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government. Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified. Medical Devices in Laos The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans: Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease; Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury; Replacement, modification, or support of anatomy or a physiological process; Supporting and sustaining life; Controlling or assisting in conception; or Disinfection and sterilization of tools and medical devices. Medical devices in Laos are given one of four classifications based on their level of risk: Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages) Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters) Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment) Class