Thailand’s Office of Insurance Commission (OIC) has released draft Notifications regarding Guidelines for Considering Qualifications and Suitability of Insurance Agents and Brokers to Manage Risks Related to Insurance Fraud for Life and Non-Life Insurance Companies for a public hearing period. The draft notifications set out criteria that life and non-life insurance companies should follow to assess the risk of brokers and agents committing insurance fraud. Risk Rating Under the OIC’s draft notifications, the risk of insurance agents and brokers committing insurance fraud is represented by four color-coded levels, according to the characteristics of the agent or broker. These levels are summarized in the table below. Insurance companies can verify the qualifications and suitability of agents and brokers by accessing information on insurance fraud in the OIC’s database. This access must comply with the Personal Data Protection Act, requiring the consent of the agent or broker whose information is being accessed. For more details on the OIC’s notification, or on any aspect of insurance regulations in Thailand, please contact Athistha (Nop) Chitranukroh at [email protected], Witchupong Chittchang at [email protected], Ajaree Trachukul at [email protected], Thammapas Chanpanich at [email protected], or Sireethorn Wijan at [email protected].

On November 4, 2021, Cambodia’s Ministry of Mines and Energy (MME) issued a Prakas No. 0305 on Management of the Steam Energy Subsector within the Energy Sector. The prakas aims to regulate steam energy operations, and requires companies wishing to develop, build, install, or operate steam energy to apply for a steam energy license. As this is the first prakas regulating steam energy operations in Cambodia, all relevant companies operating in steam energy must apply for a steam energy license with the MME. Prakas 0305 discusses permits for three types of activities: Development, Construction, Installation, and Operation of Steam Energy. Companies wishing to develop, build, install, and operate steam energy production facilities must first apply for a permit from the MME. Steam Energy Service Provision. Companies wishing to develop, build, install, and operate steam energy for the purpose of supplying steam energy to consumers must apply for a permit for steam energy service provider in addition to a permit for development, construction, installation, and operation of steam energy. Two-in-One Steam Energy and Electricity Production. Companies wishing to develop and operate both steam energy and electricity production activities must also apply for a permit for two-in-one steam energy and electricity production. Companies operating without the necessary permits are subject to a daily fine of KHR 400,000–4,000,000 (approx. USD 100–1,000). In addition, they may face other penalties, including: An order to halt business activities; Permit suspension; Permit revocation; Judicial action; and Other legal measures as the MME deems fit. For more information on regulations and requirements for steam energy licenses in Cambodia, please contact Tilleke & Gibbins at [email protected].

Thailand’s Office of Insurance Commission (OIC) has issued a notification announcing new and updated criteria for the approval of capital reductions for both life and non-life insurance companies. The notification was published in the Government Gazette on March 6, 2024. These updates aim to reduce the time required and relax and streamline the procedures for seeking OIC approval for capital reductions. Under the notification, general approval will be granted by the OIC upon submission of an application to the registrar if the capital reduction is to be implemented by way of: Removing registered shares that cannot be sold or that have not yet been issued for sale; or Reducing the share value or the number of shares to mitigate the accumulated loss. The reduction must not affect the share ratio of the shareholders in the financial statement and must comply with relevant laws, regulations, and accounting standards. After granting written approval, the registrar will notify the OIC to arrange for registration by the company. For more details on the OIC’s notification regarding capital reductions for life and non-life insurance companies, or for any issue concerning insurance regulations in Thailand, please contact Athistha (Nop) Chitranukroh at [email protected], Witchupong Chittchang at [email protected], Ajaree Trachukul at [email protected], Thammapas Chanpanich at [email protected], or Sireethorn Wijan at [email protected].

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