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Life Sciences

Life Sciences

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

Alan Adcock

     +66 2056 5871

     [email protected]

Jay Cohen

     +855 23 964 210

     [email protected]

Wongrat Ratanaprayul

     +6221 2971 8099

     [email protected]

Alan Adcock

     +66 2056 5871

     [email protected]

Prisna Sungwanna

     +66 2056 5656

     [email protected]

Yuwadee Thean-ngarm

     +95 9 772 440 002

     [email protected]

Alan Adcock

     +66 2056 5871

     [email protected]

Atthachai Homhuan

     +66 2056 5610

     [email protected]

Hien Thi Thu Vu

     +84 24 3772 5606

     [email protected]

Kien Trung Trinh

     +84 24 3772 5567

     [email protected]

OVERVIEW

Our unified teams of legal and scientific professionals across Southeast Asia offer unparalleled expertise in the life sciences.

The Tilleke & Gibbins life sciences team combines experienced commercial attorneys, patent experts with technical degrees, and licensed pharmacists with industry experience to offer a full range of services to companies operating in pharmaceuticals, cosmetics, food and beverages, biotechnology, medical devices, veterinary products, consumer products, and other life sciences sectors. We stand ready to assist you with:

  • Regulatory Affairs.   Registration and prosecution of pharmaceuticals, biotech products, food and food supplements, narcotic and psychotropic substances, medical devices, cosmetics, hazardous substances, and animal and crop health products with national food and drug agencies and agricultural regulators.
  • Corporate and Transactional.   Advising on corporate establishment, cross-border and multi-jurisdictional transactions, labor and employment, due diligence, compliance investigations, IP valuation and licensing, assignments and acquisitions, franchising, distributorship, technology transfer, and tax and customs issues.
  • IP Registration.   Strategic portfolio management of patents, trademarks, trade secrets, copyright, and geographical indications, including IP search, registration, freedom-to-operate opinions, recordal, and prosecution.
  • IP Enforcement and Litigation.   Advising on pre-litigation and arbitration, IP litigation and strategy, validity challenges and invalidations, product liability, consumer complaints and recalls, and monitoring for infringing products in the market or under the application process.
Case Studies
Thailand | Full-service

Tilleke Helps Aesop Launch First Official Signature Store in Thailand

Tilleke & Gibbins is proud to have helped well-known Australian luxury cosmetics brand Aesop with the launch of its first official signature store in Thailand, advising on a full range of legal matters from company incorporation and licensing to product registration and all stages in between.

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Life Sciences Asia-Pacific Network

The Life Sciences Asia-Pacific Network (LAN) is a professional network of leading full-service law firms providing support to life sciences industry clients on a full range of legal and regulatory matters in the Asia-Pacific region. LAN brings together eight of the leading law firms in the region.

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Thailand | Life Sciences | Full Service

Thai Market Entry for World-Leading Cannabis Companies

Advising several leading global cannabis companies on structuring Thai partnerships for the research, development, and manufacture of medical cannabis and Cannabidiol (CBD) products in Thailand.

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Experience

  • Acted as counsel to a major pharmaceutical company by liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.
  • Helped a multinational food company comply with Thai FDA requirements. Advised the client on advertising and promotional materials in Thailand, with particular emphasis on the requirements of the FDA and the consequences of improper ad content.
  • Acted on behalf of a major U.S.-based agrichemical manufacturer. The case involved termination of the client’s distributor for breach of contract and IP (patent and trademark) infringement. In addition, we represented the client in re-registration of its full range of products with the Thai Ministry of Agriculture.
  • Negotiated with the Thai FDA to reclassify a client’s drug product from a new chemical entity (NCE) to new combination (NCO) and secured the successful registration of this product.
  • Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
  • Secured an export license for the client in an efficient manner, as required by the head of the product group.
  • Coordinated the actions of multiple parties (the reviewers in Thailand, the foreign regulatory affairs authority, and the firm) to timely secure a pharmaceutical product license for the client.
  • Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
  • Handled a portfolio of products of a pharmaceutical client.  Our representation included assisting in the registration of the products, reviewing and advising on product labels, and assisting in transferring the products to a third company.
  • Secured medical device registration for a top shoe manufacturer and trader in Thailand by giving beneficial advice to the client and working closely with the client to resolve issues with its application.
  • Registered, in a seamless and efficient manner, a cosmetic product for a large importer in a limited period of time, which enabled the client to timely launch the product.
  • Advised a global pharmaceutical company on all aspects of doing business in Vietnam, including the formation and operation of a representative office, registration as a foreign pharmaceutical company, property transactions, and employment termination and labor disciplinary procedures.

PROFESSIONALS

RELATED INSIGHTS

June 19, 2026
For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements
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June 17, 2026
Thailand’s new labeling requirements for medical devices, which include for the first time a unique device identification (UDI) requirement for software as a medical device (SaMD), take effect on June 20, 2026. The Notification of the Ministry of Public Health regarding Criteria, Methods, and Conditions on Labeling and Instructions for Use for Medical Devices 2025, which replaces a similar notification from 2020, was published in the Government Gazette on December 22, 2025. To ensure clarity, modernity, and patient safety, the regulation requires domestic manufacturers and importers to provide labels and instructions for use (IFU) that are clearly legible, complete, and free of false or misleading claims. It also permits IFU to be provided in electronic format, such as via QR codes, websites, or other digital channels—directly relevant to SaMD, where physical labels are impractical and electronic presentation is the natural medium. The notification distinguishes two categories for labeling language. Home-use medical devices (for lay users outside healthcare facilities) must have labels and IFU in Thai. Professional-use medical devices may display labels and documentation in either Thai or English. This distinction is significant for SaMD developers: software intended for clinical professionals may use English-language interfaces and IFU, while consumer-facing health applications must provide Thai-language content. Labeling and UDI Requirements Labels and IFU must include, at a minimum: Product name and intended purpose Quantity or volume Name and address of domestic manufacturer or importer Thai FDA approval number Lot, version, or serial number Manufacturing date and expiry date For SaMD, the version number requirement is particularly relevant. The regulation also mandates display of a UDI code for SaMD in risk category 2 (moderate-risk), category 3 (moderate- to high-risk), and category 4 (high-risk), according to Thailand’s medical device risk classification system (which complies with the ASEAN Medical Device Directive and the EU
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June 5, 2026
On May 25, 2026, Vietnam’s Ministry of Health issued Circular No. 16/2026/TT-BYT governing free-of-charge medicine support programs for medical establishments (Circular 16). Circular 16 will take effect on July 10, 2026, replacing Circular No. 31/2018/TT-BYT, which currently regulates the same subject matter. Circular 16 introduces several significant changes compared to the existing legal framework. Removal of Prior Approval Requirement Under the current regulations, free-of-charge medicine support programs are divided into two categories: (1) entirely free-of-charge provision of medicines for all types of drugs and (2) partially free-of-charge provision applicable only to brand-name drugs under patent protection or drugs whose generic products with identical active ingredients and dosage forms are available in Vietnam. Under the current regulations, partially free-of-charge programs are subject to mandatory registration with the competent authority, while entirely free-of-charge programs could be implemented without prior approval. A key reform under Circular 16 is that it stipulates only entirely free-of-charge medicine support programs applicable to all types of medicines, thereby eliminating the partially free-of-charge category. In addition, free-of-charge medicine support programs may be carried out solely based on a written agreement between the pharmaceutical company and the medical establishment, without any requirement for prior approval from competent authorities prior to implementation. Written Agreement Requirements Circular 16 requires the pharmaceutical company and medical establishment to enter into a written agreement in accordance with a prescribed template. This agreement must include the following compulsory information: Information on the supported medicines Form of support (entirely free-of-charge provision to patients) Quantity of medicines provided Target patient groups and applicable indications Duration of the program Rights and obligations of each party Transitional provisions on the protection of patients’ rights upon completion of the program The agreement may contain other contents as agreed by the parties, provided that these do not contradict applicable laws.
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June 4, 2026
Indonesia’s Minister of Health has issued Decree No. HK.01.07/MENKES/301/2026 on the Affixation of Nutritional Labels and Health Information to Ready-to-Eat Processed Food Products. The decree came into force on April 14, 2026, and was issued to implement the Health Law and Minister of Health Regulation No. 3 of 2026 on Disease Control. The decree requires the inclusion of Nutri-Level labeling on the front-of-pack nutrition labeling (FOPNL) to indicate the product’s nutritional level based on the content of sugar, salt, and fat (“gula, garam dan lemak (GGL)”). Changes from 2024 Draft Regulation The Nutri-Level labeling was previously proposed in 2024 by the Indonesian FDA (BPOM) through a draft regulation concerning nutrition information. While the categories of Nutri-Level labeling remain the same in the issued decree, the content requirements of sugar, salt and fat in the decree are different from the earlier proposal introduced in the 2024 draft BPOM regulation. In addition, the decree has further specified that the content of fat in the Nutri-Level labeling is the content of saturated fat, not total fat as previously proposed in the 2024 draft. The decree requires Nutri-Level labeling to be implemented in beverage products, which is the same as previously proposed in the 2024 draft BPOM regulation. Other food products may gradually become subject to mandatory Nutri-Level labeling under future implementing regulations. Nutri-Level Labeling Food levels as shown by the Nutri-Level labeling are classified into four color-coded categories from A to D: Level A (lowest amount) in dark green Level B in light green Level C in yellow Level D (highest amount) in red The Nutri-Level labeling is represented by the following image. The requirements for each level for sugar, salt, and fat content, based on amounts per 100 milliliters of product in beverage form, are as follows. Nutri-Level information must be
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AWARDS & RANKINGS
September 12, 2025
The 2025/2026 edition of the IFLR1000 Asia-Pacific rankings, released by International Financial Law Review (IFLR), highlights Tilleke & Gibbins’ continued excellence in financial and corporate transactional work. The firm has maintained its strong rankings across multiple jurisdictions and practice areas while achieving notable upgrades and new recognitions, reaffirming its position as a leading firm in the Asia-Pacific region. This year, Tilleke & Gibbins received firmwide rankings in key jurisdictions, including: Thailand Banking & Finance—Tier 3 Capital Markets: Debt—Tier 3 Capital Markets: Equity—Tier 3 M&A—Tier 2 Project Development—Tier 2 Restructuring & Insolvency—Tier 3 Vietnam Banking & Finance—Tier 4 M&A—Tier 3 Project Development—Tier 3 Cambodia Financial & Corporate—Tier 2 Project Development—Tier 2 Laos Financial & Corporate—Tier 2 In addition to these firmwide rankings, Tilleke & Gibbins had several standout individual recognitions, with 12 lawyers honored in the 2025/2026 individual rankings—an increase from last year’s 10. This year’s results include upgraded rankings for John Frangos and new rankings for Charupat Boon-Long, Derrick Khoo, Prisna Sungwanna, and Saravut Krailadsiri. The full list is as follows: Charunun Sathitsuksomboon—Highly Regarded, M&A, Thailand; Women Leader Charupat Boon-Long—Rising Star, M&A, Thailand (new ranking) David Mol—Rising Star, Corporate and M&A, Cambodia Derrick Khoo—Rising Star (Partner), Financial and Corporate, Thailand (new ranking) Jay Cohen—Highly Regarded, Banking, Cambodia John Frangos—Highly Regarded, Restructuring & Insolvency, Thailand (upgraded ranking) Niti Muangkote—Rising Star, Financial & Corporate and Project Development, Laos; Highly Regarded, Banking & Finance, Thailand Prisna Sungwanna—Highly Regarded, Financial & Corporate, Laos (new ranking) Saithong Rattana—Notable Practitioner, Project Development and M&A, Laos Santhapat Periera—Highly Regarded, Banking & Finance and M&A, Laos; Highly Regarded, Banking & Finance, Thailand Saravut Krailadsiri—Notable Practitioner, Thailand (new ranking) Tram Ngoc Bich Nguyen—Highly Regarded, M&A, Vietnam To see the full set of IFLR1000 rankings for Tilleke & Gibbins’ jurisdictions, please see the Cambodia, Laos, Thailand, and Vietnam pages
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September 3, 2025
Tilleke & Gibbins is honored to announce that the firm has been shortlisted for three prestigious categories at the Asialaw Awards 2025. This year’s shortlist reflects the outstanding work of the firm’s teams across Southeast Asia and highlights their ongoing commitment to delivering exceptional client service in the region. In the firmwide category, Tilleke & Gibbins was nominated for: Cambodia Firm of the Year Laos Firm of the Year In the individual category, Prisna Sungwanna was shortlisted for Laos Female Lawyer of the Year, joining an impressive field of nominees from other leading firms. The Asialaw Awards celebrate the most outstanding firms and lawyers across the Asia-Pacific region. The 2025 winners are set to be announced at an awards ceremony in Ho Chi Minh City in November. For more information on the Asialaw Awards 2025 and to browse a full list of the nominees, please visit the Asialaw website.
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August 14, 2025
Tilleke & Gibbins is pleased to announce that Alan Adcock and Somboon Earterasarun have been named to the IAM Strategy 300 2025, an annual list that identifies the world’s leading professionals in intellectual property strategy. This marks Alan’s 15th consecutive year of inclusion in the IAM Strategy 300, recognizing his extensive experience in legal strategy, licensing, mergers and acquisitions, technology transfer, and IP valuation. Somboon has been included for the third consecutive year, highlighted for his strengths in IP management consultancy, licensing, and legal strategy. Their continued recognition reflects Tilleke & Gibbins’ capabilities in helping clients develop and implement effective strategies to maximize the value of their intellectual property assets.
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