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,

On December 15, 2023, the Electricity Authority of Cambodia (EAC) issued a notification requiring all owners of solar power systems to report their systems to their local electricity supplier by January 31, 2024. Systems that have already been reported under existing regulations are exempt from this requirement. Systems that remain unreported after the deadline will be deemed illegal and subject to penalties, including possible disconnection from the national grid. The rationale for the reporting requirement is that the EAC expects to adopt a new solar power regulation soon. Electricite du Cambodge (the main state-owned utility provider in Cambodia) and EAC-licensed private electricity providers are now gathering data on the current use of solar power systems in order to prepare for, adopt, and execute the upcoming regulation. The reporting requirement is to facilitate this gathering of data. The upcoming regulation, planned for early 2024 according to the notification, follows last year’s Prakas No. 159, which contained the Ministry of Mines and Energy’s guidelines and principles for rooftop solar systems. The EAC now needs to issue implementing regulations that are in line with the ministry’s guidelines and principles. Although stand-alone solar power systems that did not have a connection to the national grid were previously not regulated and did not require any authorizations, the EAC is now stating that all types of solar power systems need to adhere to the reporting requirement under the notification. According to the EAC, the upcoming regulation will address all types of systems, and the December 15 notification clearly announces that all types of solar power systems will need to obtain EAC approval under the upcoming regulation. Solar power system operators in Cambodia should report their systems to their local electricity providers by January 31, 2024, to avoid any penalties, while remaining vigilant for the upcoming

Thailand’s Energy Regulatory Commission (ERC) has issued the Notification on the Criteria for Regulating the Licensed Pool Manager B.E. 2566 (2023), which took effect on November 30, 2023. It followed an earlier notification, which took effect on October 13, 2023, that added the new license for the country’s pool gas manager. The new notification aims to regulate natural gas sale agreements and promote competition among players in the regulated natural gas market—that is, those who utilize natural gas for electricity generation under the Electricity Generating Authority of Thailand (EGAT) scheme, including industrial and NGV (natural gas for vehicles) consumers who rely on natural pool gas. The establishment of the pool gas scheme is aimed at encouraging new shippers to enter the market and providing new natural gas shippers with fair opportunities to compete with existing shippers, as all licensed shippers in the regulated market are subject to the same natural gas costs under this new scheme. Under this pool gas scheme, the pool manager plays a critical part in reselling natural gas in the country. Some of its responsibilities include the following: Purchasing natural gas or liquid natural gas (LNG) from licensed shippers in the regulated market at the rate at which the shippers procured the natural gas, including incidental expenses such as pipeline transportation and LNG station fees; Collecting data on the quantity and price of the gas purchased from the licensed shippers and calculating the pool gas price as specified in the ERC-approved manual, which is basically the average price of the natural gas procurement cost of all shippers in the pool; and Reselling natural gas or LNG to licensed shippers at the pool gas pricing rate in the quantity distributed to the pool by each shipper. Apart from its function in facilitating the primary procedures of