Life sciences specialists from Tilleke & Gibbins have updated the firm’s guide to pharmaceutical data exclusivity regulations and practices in Southeast Asia. This guide contains quick-reference information on the availability of data exclusivity protections and limitations in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, and Vietnam. Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support

For companies and individuals doing business in Vietnam, a common question is whether electronic signatures (e-signatures) are legally recognized under Vietnamese law. This matter is governed by Law No. 20/2023/QH15 on Electronic Transactions issued on June 22, 2023 (ETL 2023) and its guiding legal documents such as Decree No. 23/2025/ND-CP dated February 21, 2025, and Circular 06/2024/TT-BTTTT dated July 1, 2024 (Circular 06). Recognition of Validity of E-signatures in Vietnam As a general principle, the ETL 2023 confirms that an e-signature cannot be denied legal validity solely due to its electronic form. The law categorizes e-signatures into three types: Type 1: Specialized e-signatures for organizations Type 2: Public digital signatures for individuals and organizations Type 3: Specialized digital signatures for government agencies Among these types, only secure specialized e-signatures (a secure e-signature of type 1) and digital signatures (type 2) are explicitly granted the same legal validity as handwritten (wet) signatures. This distinction is particularly important in legal disputes and for transactions with government agencies. (For more details, please refer to our previous article.) Domestic e-signatures A domestic organization can choose to use secure specialized e-signatures (type 1) and/or digital signatures (type 2) while a Vietnam-based individual can choose digital signatures (type 2) for their transactions—particularly for those involving government agencies and transactions of high value and complexity which require stronger legal protection. Specialized e-signatures (type 1) can be created by the organizations themselves, and additionally must be “secure” to be explicitly recognized as having the same legal validity as handwritten signatures. For clarity, “secure” specialized e-signatures are those certified (granted a safety certificate) by the Ministry of Science and Technology (MST). (This was formerly the responsibility of the Ministry of Information and Communications, which was merged with MST under Vietnam’s 2025 administrative restructuring.) Digital signatures (type 2) are

On June 16, 2025, the National Assembly of Vietnam adopted Law No. 75/2025/QH15 amending and supplementing a number of articles of the 2012 Advertising Law, with an effective date of January 1, 2026. The amended Advertising Law was enacted to further refine the legal framework for advertising activities in the modern era. Online Advertising Under the amended Advertising Law, “online advertising” is defined to encompass not only advertising on electronic newspapers and electronic information pages (as provided under the 2012 Advertising Law) but also advertising on other electronic venues, including social media, online applications, and digital platforms with internet connection. The amended Advertising Law also imposes new requirements for online advertising, including: Identification signs: Advertisements must have clear identifiable signs in numbers, letters, symbols, images, or sounds to distinguish them from non-advertising content. Control features: For advertisements not in fixed areas, there must be easily recognizable features and icons that allow recipients to turn off the advertisement, notify the service provider of violating advertising content, and refuse to view inappropriate advertising content. Linked content: Content in the links embedded in advertisements must comply with the law. Advertising service providers and publishers must have measures to check and monitor the linked content. Advertising on social media: Organizations and enterprises providing social media services must offer users features to distinguish advertising content from other content. Signage for sponsored content: When advertising, users of social media services must use signs to differentiate advertising or sponsored content from other content they provide. In response to the above requirements for online advertising, the amended Advertising Law sets out obligations of advertisers, advertising service providers, advertising publishers, and advertising conveyors in relation to online advertising. Among these, it is notably the responsibility of individuals and organizations engaging in online advertising to prevent and remove violating

On June 20, 2025, Cambodia’s Ministry of Economy and Finance issued Instruction No. 19116 to clarify when board members and company directors must receive salaries and pay payroll taxes. Board members and company directors who are not considered employees are subject to a withholding tax. This category consists of people who complete services for a nonresident individual and people who perform independent work for a company in Cambodia. Board members and company directors who are considered employees, including those appointed by a foreign head office to temporarily manage a company in Cambodia, must pay payroll taxes on any salary they receive, regardless of whether they are paid by a local or foreign branch of the company. The above obligations apply regardless of whether the person has a work permit. Board members and company directors are exempt from paying payroll tax if they: Are not present and not performing a regular management role at the company despite being registered on the company’s statutes or patent tax card; Participate only in board meetings and occasional shareholder meetings; and Do not receive a salary from a company in Cambodia. Overall, this instruction provides an important clarification regarding the tax obligations of board members and company directors. Companies should pay attention to the classification of their board members and directors and be mindful of the exemption.   This article was written with the assistance of Tilleke & Gibbins interns Amelia Gemma Erickson and Amrin Keat.