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

Thailand’s Department of Mineral Fuels (DMF) has developed a framework to regulate carbon capture and storage (CCS) and related activities by introducing “carbon business” to the draft amendment to the Petroleum Act B.E. 2514 (1971). CCS involves the capture, treatment, transport, and underground storage of carbon dioxide produced from industrial power generation. The captured carbon can be used to enhance oil recovery, converted into fuel such as methane or DME (dimethyl ether), or converted to higher-value products. In Thailand, various companies have carried out CCS feasibility studies. Carbon Business and Licensing Under the draft amendment to the Petroleum Act, “carbon business” is defined as exploration for purposes of carbon storage or compression of carbon into carbon storage, while “carbon” is defined as carbon dioxide in the state of gas or supercritical fluid generated as a byproduct or captured from other sources and transported for storage. Any concessionaire, product-sharing contractor, or service contract holder that has been granted permission to explore for or produce petroleum under the Petroleum Act can apply for a carbon business license from the director-general of the DMF with the approval of the Petroleum Committee. Licenses are also available to any other parties who meet the eligibility criteria to be prescribed later by a ministerial regulation. Licenses for these parties will be allocated through competitive bidding according to procedures to be announced by the minister of the Ministry of Energy (MOE). In granting a license, the minister of the MOE and the director-general of the DMF will consider the geological suitability of carbon storage, storage systems, surrounding areas of carbon storage, risk of carbon leakage and movement, environmental impacts, and the applicant’s financial potential and ability in environmental management. Responsibilities of Carbon Business Operators Carbon business operators are required to monitor and inspect their installations, structures,

Tilleke & Gibbins’ insurance specialists in Bangkok provided Thomson Reuters’ latest country update on Thailand’s regulatory framework for the insurance industry. The country update, which is part of Thomson Reuters’ extensive Regulatory Intelligence offerings, contains information and guidance for insurers active in the Thai market. The guide covers the following topics in detail: Permission to operate; Legal and regulatory considerations for domestic and international insurers; Capital reserve requirements; Investment management and markets; The Office of Insurance Commission’s arbitration system for handling complaints; Creditor hierarchy; Rehabilitation of non-life insurance companies; and Personal data protection requirements for insurers. The full PDF of the Thailand insurance country update is available below, or by subscription to Regulatory Intelligence on the Thomson Reuters website.