On January 9, 2025, the Lao official gazette published the newly amended Decision on Trade Inspection Implementation No. 0019/MOIC, dated January 6, 2025. This decision aims to establish principles and rules for trade officers to inspect, fine, and take measures against violators of trade laws and their related regulations on business competition, business operations, and intellectual property rights to protect consumers and business operators in Laos. Changes in Trade Inspection Procedures Previously, trade inspection officers, operating independently under the central Ministry of Industry and Commerce (MOIC) or the provincial-level Department of Industry and Commerce (DOIC), were responsible for administrative raid actions focusing exclusively on intellectual property issues. However, following the enactment of Decision No. 0019/MOIC, trade inspection officers will now be grouped into the Trade Officers Unit, which will also include business competition officers and consumer protection officers. This unit will conduct and participate in raids, considering not only intellectual property laws but also competition and consumer protection laws when imposing penalties on infringers. Trade Inspection Authority Levels Trade inspection implementation is overseen by authorities at three levels: Central level: Department of Business Competition and Trade Inspection, MOIC. The MOIC handles trade inspection work covering all provinces in Laos. Provincial level: DOIC offices in provinces and Vientiane handle trade inspections covering two or more districts. District level: Office of the Industry and Commerce offices in districts. Violations Individuals, legal entities, and organizations violating the newly amended trade inspection decision, the Decree on Trade Inspection, or other related regulations will be educated about the issue, warned, disciplined (for government servants), fined, subject to compensation for damage incurred, or punished by the relevant laws, depending on the gravity of the violation. Trade Violations Violations of trade laws and regulations concerning business operations will result in fines and additional measures. Examples include: Failure to display product prices: Fines ranging from LAK 500,000 (approx. USD 25)

Thailand has amended its primary anticorruption law to provide robust new protections and direct assistance to whistleblowers. The Organic Act on Anti-Corruption (No. 2) B.E. 2568 (2025) was published in the Government Gazette on June 5, 2025, and came into force the following day. The amendment introduces a clear framework for safeguarding and supporting individuals who report graft. The amendment addresses a critical gap in the previous legislation by establishing formal mechanisms to protect and assist those who come forward with information. The key changes aim to shield whistleblowers from retaliatory legal and disciplinary actions, thereby encouraging more citizens to participate in exposing corruption without fear of reprisal. Key updates to the law are discussed below. Whistleblower Immunity The amendment clarifies and strengthens legal immunity by revising section 132 of Thailand’s original anticorruption law from 2018. Under the revised section, individuals who provide good-faith statements, information, evidence, or opinions to the National Anti-Corruption Commission (NACC) regarding offenses under its jurisdiction will be protected from civil, criminal, and disciplinary liability. This protection is explicitly extended to individuals who provide information to other state agencies tasked by the NACC to investigate corruption, such as the Public Sector Anti-Corruption Commission or the whistleblower’s own supervisors. Protection and Assistance A new section added to the law establishes a clear and swift process for activating protections. When the NACC learns that a whistleblower is facing legal complaints, criminal charges, or disciplinary action due to their report, the commission must review the matter and decide on providing protection within 15 days. If the NACC determines that the whistleblower acted in good faith, its office is required to provide immediate assistance. Legal and Financial Support Another newly introduced section outlines a wide range of assistance measures the NACC office can provide in civil and criminal cases as well as disciplinary proceedings, as outlined below: In

In today’s digital age, cyberattacks have become a real threat to organizations worldwide. These attacks can range from phishing and malware to ransomware and distributed denial of service (DDoS) attacks. As the frequency and sophistication of these attacks increase, so does the importance of cybersecurity compliance. In the corporate world, compliance refers to the process of ensuring that a company and its employees adhere to all relevant laws, regulations, standards, and ethical practices—but it should not stop there. Compliance should also encompass asset recovery and disciplinary measures, which can both help organizations address incidents effectively and promote good governance. Cyberattacks are malicious attempts to access or damage a computer system or network, often carried out for financial gain, for political activism, or simply to cause disruption. For instance, a successful attack might involve an attacker creating an email address that closely resembles a legitimate one, perhaps by changing only one or two characters. That email address is then inserted into an existing conversation thread, making it appear as if the user with this email address was already part of the discussion. This tactic can easily deceive a recipient into believing the email was sent from a trusted source, thereby leading them to click on malicious links, provide sensitive information, or even make payments in accordance with the attacker’s request or instructions. Phishing attacks like these are particularly dangerous and can have a serious impact on the ongoing business of a corporation because they exploit the trust and familiarity established in the original email chain. Effective Mitigation Approaches Mechanisms for addressing the aftermath of a crisis provide important recourse to affected organizations, but effective compliance mechanisms can minimize the risk of such crises ever occurring. Companies should therefore prioritize preventative measures and implementation of effective crisis management schemes. Various legal and regulatory frameworks govern cybersecurity

Thailand’s Ministry of Finance has issued a royal decree placing the business of hire purchase and leasing of cars and motorcycles under the scope of the Financial Institution Business Act B.E. 2551 (2008), effective December 2, 2025. This is to ensure appropriate regulatory oversight of these business activities, as they function similarly to credit granting and serve as a source of funding for the public with a broad impact on the overall economic system and consumers at large. The business operators that this royal decree applies to include corporate entities engaging regularly in the business of hire purchase or leasing of cars or motorcycles, currently excluding: Financial institutions and specialized financial institutions. Individuals operating such businesses (noncorporate entities). Cooperatives. Key regulatory obligations of this royal decree include the following: Business operators must disclose interest rates, service fees, and other relevant business information to the public and report to the Bank of Thailand (BOT). Business operators must display how the annual percentage rate (APR), including all annual charges covering interest and service fees, is calculated. Business operators must maintain accurate accounting records in accordance with recognized accounting standards. The BOT may issue warnings or suspend operations if business operators fail to comply with this royal decree or act unfairly in a way that may result in serious harm to customers. Directors, managers, and responsible persons of any business operator that violates this royal decree may also be subject to the prescribed penalties. Before the royal decree takes effect, business operators should conduct internal assessments and engage with counsel to prepare for regulatory implementation. The BOT is expected to issue further subordinate regulations and guidance regarding: Interest, service fees, deposits, collateral, benefits, and penalties that may be charged by business operators. Contract content, methods of benefit calculation, and format in conducting business with customers. Requirements for contracts that grant the business operator the right to

Myanmar’s Ministry of Commerce has established new regulatory measures for importing electric vehicles (EVs) as part of a pilot project running from January 2025 to March 31, 2026, while the Ministry of Planning and Finance has reduced customs duty rates for fuel-powered vehicles manufactured domestically under semi-knocked down (SKD) and completely knocked down (CKD) systems, effective June 1, 2025, to May 31, 2026. Importation of EVs On May 29, 2025, Myanmar’s Ministry of Commerce (MOC) issued an announcement regarding the importation of EVs from abroad as part of its pilot project, detailed in MOC Notification No. 40/2025. The MOC notification establishes the following regulatory measures to support the development of EVs and related businesses: Approval must be obtained from the National-Level Steering Committee for the Development of Electric Vehicles and Related Enterprises. A registration certificate for an EV sales showroom must be secured. Vehicles must be imported in accordance with the permitted number and standards defined by the National-Level Steering Committee for the Development of Electric Vehicles and Related Enterprises. The importing company must provide necessary arrangements for warranties on imported EVs, spare parts, and after-sales services. For companies wishing to open a sales showroom, the following requirements apply: The company must be a registered national or joint venture entity with the Directorate of Investment and Company Administration. The company must be officially appointed as a distributorship or dealership by the original company or regional office for each brand. A permit from the respective state or regional government and a business license from the respective Municipal Committee must be obtained. The company must provide evidence of tax clearance issued by the Internal Revenue Department. Standards for the showroom, building, and warehouse, as issued periodically by the MOC, must be adhered to, including: Compound area: 10,000 square feet (the total area for the showroom, service center, and waiting room must be 5,000 square feet). Warehouse:

Thailand’s tax dispute resolution framework has undergone a significant transformation with the enactment of the Act Establishing the Tax Court and the Procedure for Tax Cases (No. 3) B.E. 2568. Published in the Government Gazette on May 27, 2025, the amended act will come into force on November 24, 2025, which is 180 days after its publication. The amended act marks a pivotal shift in the jurisdiction and procedures of the Tax Court, most notably by empowering it to adjudicate certain criminal tax cases for the first time. Background and Rationale The Tax Court was originally established in 1985 as a specialized forum to handle complex tax disputes, including those related to revenue, customs, and excise taxes. The creation of the Tax Court recognized the need for judicial expertise in tax law, given its technical and specialized nature. The latest amendment is designed to address procedural inefficiencies, modernize court processes, and align Thailand’s tax litigation system with international standards. The reform demonstrates Thailand’s commitment to enhancing the efficiency, transparency, and fairness of its tax dispute resolution mechanisms. Key Amendments and Provisions Six of the key changes in the amendment are highlighted below. Expansion of jurisdiction to criminal tax cases. The most significant change is the extension of the Tax Court’s jurisdiction to include criminal offenses under the Revenue Code, customs law, excise tax law, and other tax-related laws that may be specified by royal decree. New sections in the act explicitly grant the Tax Court authority to hear and decide criminal tax cases, so individuals and entities accused of criminal tax evasion or other tax-related crimes will now have their cases heard by judges with specialized tax expertise. The law also clarifies the Tax Court’s jurisdiction when a single act constitutes multiple offenses (some tax-related, some not) or when there are multiple related offenses.

タイ食品医薬品局（FDA: Food and Drug Administration）は、オンライン販売される健康関連製品に対する規制監督を強化するため、大手電子商取引プラットフォームのLazadaおよびShopeeとの戦略的提携を開始した。本提携は、消費者保護の強化、タイの保健関連規制の遵守の徹底、そして健康関連製品のより安全なデジタルマーケットプレイスの促進を目指す、より広範な取り組みの一環である。 この取り組みの一環として、タイ食品医薬品局は、すべての販売業者、特に越境販売業者に対し、市場参入前に製品の適切なFDA登録を取得するよう強く求めている。その目的は、合法的に認可され、安全で品質が保証されたヘルスケア製品のみがタイの消費者に提供されるようにすることである。 この目標達成のため、タイ食品医薬品局は、LazadaおよびShopeeと緊密に協力し、不適合であったり、基準を満たさない、または未登録の製品を特定・削除するための積極的な監視メカニズムを導入してきた。このような連携は既に目に見える成果を上げている。2023年9月から2024年の間に、Lazadaは9,454件の不適合商品を削除し、30社の販売業者をリストから削除することで、規制の執行を支援した。さらに、134社の販売業者が規制違反で法的措置を受けた。Shopeeも同様に厳格な姿勢をとっており、FDA規制に違反していることが判明した製品は直ちに削除することを約束している。Shopeeはまた、販売業者向けの教育資料を提供し、説明責任を強化するために消費者からの苦情受付メカニズムも導入している。 タイ食品医薬品局は今後、API技術を活用したデータ統合システムを導入し、タイ食品医薬品局と電子商取引プラットフォームとの間で規制データをシームレスかつ安全に交換できるようにする予定である。このシステムは、タイ食品医薬品局職員と電子商取引担当者との両方を対象とした包括的な研修によってサポートされ、特にタイ政府のLaw Enforcement Request Portal（政府機関とプラットフォーム運営者と間のエンフォースメント措置を調整するための安全なコミュニケーション・チャネル）の活用に重点が置かれている。 さらに、LazadaおよびShopeeとの提携により、共同製品検査フレームワークの開発が現在進められている。このフレームワークには、厳格なコンプライアンス基準が組み込まれており、公衆衛生法に違反する販売業者に対してエンフォースメント可能な罰則が規定されている。タイ食品医薬品局はまた、オンラインマーケットプレイスにおける違法な健康関連製品の販売の検出及び防止を強化するために、先進技術を駆使した次世代のインテリジェント検査システムの導入も準備している。 これらの共同の取り組みは、急速に進化する電子商取引環境において、タイ食品医薬品局が公衆衛生及び法令遵守に継続的に取り組んでいることの具体的な例である。したがって、これらのプラットフォームで事業を展開する越境販売業者は、自社製品がタイの規制要件を完全に遵守していることを強く推奨します。遵守しない場合、製品の撤去や法的措置につながる可能性がある。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。 Thai FDA Partners with E-commerce Platforms to Regulate Health Products Online

ベトナム保健省（Ministry of Health ）は、2025年5月16日、医薬品及び医薬品原料の登録に関する通達第12/2025/TT-BYT（Circular No. 12/2025/TT-BYT on registration of drugs and drug materials）（以下、通達第12号という。）を公布した。通達第12号は、医薬品登録に関する現行規則である通達第08/2022/TT-BYT（改正版）、委託製造及び技術移転における医薬品の登録に関する通達第16/2023/TT-BYT、並びに市販薬リストを公表する通達第07/2017/TT-BYTに代わるものであり、2025年7月1日に施行される。 通達第12号の主な規定の一部を以下に概説する。   市販薬の規制 通達第12号は、従来通達第07/2017/TT-BYTで規定されていた市販(over-the-counter)薬の詳細なリストを廃止するものである。分類用固定リストに依拠する方法に代えて、通達第12号では、非処方薬／市販薬の分類に関する原則、基準、および具体的な方法に基づく新たな枠組みを導入している。このアプローチは、安全性の向上、迅速なアクセスの確保、実際の使用状況と供給状況の反映、そして国際基準への適合を目的としている。 既に承認されている医薬品は、販売承認（marketing authorization）の有効期間中、その分類（すなわち、処方薬または非処方薬）が維持され、販売承認の更新時に再分類が検討される。分類の変更を申請する場合、販売承認保有者はベトナム医薬品管理局（Drug Administration of Vietnam）に変更申請用書類（variation registration dossier）を提出する必要がある。 現在 ベトナム医薬品管理局 によって評価中の医薬品登録用書類については、通達第12号に定められた新しい規定に従って分類が評価される。   医薬品登録 通達第12号の規則は、医薬品証明書（Certificate of Pharmaceutical Product）の提出要件を緩和している。すべての医薬品登録において、製造国の管轄当局、または欧州医薬品庁（European Medicines Agency）加盟国もしくはSRA（Stringent Regulatory Authority）が発行し、当該医薬品がその国で認可され、積極的に販売されていることを確認する医薬品証明書が1通あれば十分となる。従前の規則では、特定の状況において追加の医薬品証明書または同様の法的文書が必要となる場合があった。 他の機関によって評価された登録用書類の参照結果を利用した医薬品の登録に関して、 ・登録用書類は、評価報告書に記載されているとおり、欧州医薬品庁またはSRAによる医薬品の初回承認日から5年以内にベトナムに提出する必要がある。 ・ベトナムに提出される登録用書類には、( i )欧州医薬品庁またはSRAが発行した評価報告書、および(ii)ベトナムの医薬品登録用書類と欧州医薬品庁/SRAが承認した書類との類似点の比較表が含まれている必要がある。 販売承認延長：新しい規則では、販売承認の有効期限が切れる前であればいつでも延長用書類を提出できる。 追加登録用書類のタイムライン：ベトナム医薬品管理局からの欠陥通知に応じて追加登録用書類を提出する期限は、すべてのケースで 6月間に短縮されている。 追加申請回数の制限：通常、ベトナム医薬品管理局専門家からの要請に応じて、最大２回の追加申請が許可される。3回目の追加申請は、2回目の申請中に追加の要件が提示された場合にのみ許可される。これらの制限は、医薬品登録諮問委員会（Advisory Council for Drug Registration）が発行する追加申請には適用されない。   見解 通達第12号は、ベトナムにおいて医薬品および医薬品原料を製造・取引する企業に影響を与える。これらの企業は、改正規定を適時に遵守できるよう、新しい規則を徹底的に検討することを提案する。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。 Vietnam Issues New Regulations on Drug Registration