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Life Sciences

Life Sciences

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

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.

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

May 29, 2026
Indonesia’s Food and Drug Authority (BPOM) has issued Regulation No. 7 of 2026 on Drug Promotion and Advertising, establishing an updated framework for promotional activities involving medicinal products in Indonesia. The regulation took effect on April 16, 2026, and supersedes BPOM Regulation No. 2 of 2021 on Drug Advertising Supervision. The new regulation maintains general principles for advertising content, including requirements that advertisements be objective, complete, and not misleading, as further detailed in its annex. It also confirms that advertisements for nonprescription drugs directed to the public must obtain prior approval from BPOM before publication and must be in Bahasa Indonesia. The regulation provides a more comprehensive framework governing how drug promotion is conducted, introducing several notable additions and changes, as described below. Procedure and Requirements for Drug Advertisement Approval To apply for a drug advertisement approval, applicants must create an online account through the dedicated portal SIAPIK. Advertisement approval is available only for registered drugs; unregistered drugs are not eligible for advertisement approval with BPOM. The application must include the advertisement design, along with a translation if the design contains any wording in a foreign language. The submission format varies by media type, requiring, for example, copies in the form of print advertisements for visual media, scripts for audio media, and storyboards for audiovisual media. For online media—including social media—submissions should include any captions, descriptions, and hashtags that form an integral part of the advertising material. The approval timeline takes approximately 3–4 months, as BPOM will generally request additional information or revisions during the verification and evaluation process. Applicants have 20 days to submit any such requested documents. BPOM may also conduct a reevaluation of advertisements that have already received approval, based on monitoring results or new information regarding the safety and quality of the advertised drug. This
May 11, 2026
Vietnam’s legal framework governing chemicals has undergone significant reform, with the Law on Chemicals No. 69/2025/QH15 (Law on Chemicals 2025) taking effect on January 1, 2026. Together with a comprehensive set of implementing instruments issued in January 2026, including three decrees (No. 24/2026/ND‑CP, No. 25/2026/ND‑CP, and No. 26/2026/ND‑CP) and two circulars (No. 01/2026/TT‑BCT and No. 02/2026/TT‑BCT), the Law on Chemicals 2025 has significantly reshaped chemical registration and management requirements. Determining What Constitutes a “New Chemical” Among the most notable changes introduced under the Law on Chemicals 2025 are the rules governing the registration and management of new chemicals, which must be registered with the authority before being placed on the Vietnam market. Although the concept of new chemical registration was first introduced under the Law on Chemicals 2007, the corresponding registration mechanism has remained largely dormant in practice. Under the Law on Chemicals 2025, a “new chemical” is defined as a substance that is not yet included in Vietnam’s National Chemical Inventory and the list of foreign chemical inventories recognized by the competent Vietnamese authority (List of Foreign Chemicals). On a literal reading, the definition in the new law may suggest that a substance qualifies as a new chemical only if it is absent from both lists. Accordingly, a chemical present in either list should be treated as an existing chemical without the registration burden. However, a different interpretation emerges from Decree 26, which specifically requires registration of “new chemicals” even where such substances already appear in the List of Foreign Chemicals. This implies that inclusion in a recognized foreign inventory does not automatically exempt a substance from new chemical registration in Vietnam. This inconsistency between the statutory definition in the Law on Chemicals 2025 and the implementing provisions of Decree 26 creates significant interpretative and compliance challenges. At
April 29, 2026
Effective June 22, 2026, Thai Industrial Standards (TIS) for food contact paper and cooking paper will be enforced as mandatory for sale in the Thai market. This move has important implications for product licensing and tightens hygiene, labeling, and chemical-safety requirements for food-contact and cooking paper products. Thailand is strengthening its regulatory framework for paper-based culinary materials against a backdrop of accelerating global commitments to ESG and sustainability, as such materials—particularly those derived from natural or recycled fibers—have emerged as key alternatives to plastics in food preparation, cooking, and packaging applications. As a result, regulators worldwide are tightening controls to ensure that sustainability initiatives do not compromise consumer safety, particularly regarding the potential migration of chemical substances into food. Regulatory Framework: Voluntary vs. Mandatory Standards Standards under the TIS regime are generally classified into two categories. Voluntary standards allow manufacturers or importers to apply for a product license and affix the TIS mark to demonstrate product quality and build consumer confidence, but compliance is not legally required. Mandatory standards, by contrast, require manufacturers and importers to obtain a product license and affix the TIS mark before placing products on the Thai market, and noncompliant products cannot be legally sold. Previously, the TIS standards for food contact paper (TIS 2948-2562) and cooking paper (TIS 3438-2022) fell under the voluntary standard regime, meaning that obtaining a TIS license and displaying the TIS mark was optional. However, due to the increasing use of paper in food preparation and cooking, the Thai Industrial Standards Institute has determined that upgrading these standards to mandatory status is necessary to enhance consumer safety. As a result, all paper intended for food contact or cooking purposes must now obtain a TIS product license prior to sale in Thailand. Scope of the Standards The primary distinction between the
April 22, 2026
A new decree in Vietnam brings significant implementation clarity to the country’s existing extended producer responsibility (EPR) legal framework. An EPR mechanism was first codified in Vietnam in the 2020 Law on Environmental Protection amid ongoing challenges surrounding the collection and treatment of product and packaging waste. The mechanism was progressively detailed through Decree No. 08/2022/ND‑CP and its successive amendments, but the regulatory framework remained insufficiently developed, notably in terms of support mechanisms for waste collection, recycling, and treatment. The newly launched regulations in Decree No. 110/2026/ND-CP (Decree 110), issued on April 1, 2026, and taking effect on May 25, 2026, stipulate fully and clearly the responsibility of manufacturers and importers to recycle products and packaging and to treat waste. Some key provisions of Decree 110 for manufacturers, importers, and related stakeholders are presented below. Subjects of EPR The Law on Environmental Protection assigns responsibility to manufacturers and importers for product and packaging recycling (under Article 54) or waste collection and treatment (under Article 55), depending on the type of products and packaging they produce or import. Decree 110 elaborates on these EPR provisions by specifying the responsible entities and listing out the types of products and packaging subject to recycling and waste treatment responsibilities. Decree 110 clarifies the responsible entities in special cases, such as when products under the same brand are made by multiple manufacturers, when there is a contract manufacturing or entrusted import relationship, and when the manufacturer or importer is part of a corporate group. Notably, exemptions may be applied in some scenarios, such as for manufacturers and importers of products and packaging exclusively for export, temporary import and re-export, or research and testing purposes, as well as for entities with annual revenue from related products not exceeding VND 30 billion. Recycling Responsibilities Decree 110
AWARDS & RANKINGS
July 21, 2025
Tilleke & Gibbins has been nominated for Southeast Asian Firm of the Year at Law.com’s Asia Legal Awards 2025. This nomination follows the firm’s win last year and reflects the team’s ongoing commitment to delivering exceptional legal services across the region. The winner will be announced at the in-person awards ceremony in Singapore on September 10, 2025. For more information on the Asia Legal Awards 2025, and to browse the full list of nominees in all categories, please visit the Law.com International website.
May 13, 2025
Tilleke & Gibbins has been recognized in the In-House Community (IHC) Firms of the Year 2024, earning accolades across 19 categories in Thailand and Vietnam. The results, based on surveys of in-house counsel across Asia, reflect client perspectives on the quality and responsiveness of legal services in key practice areas. The firm received 11 Firm of the Year awards and two honorable mentions in Thailand, along with six Firm of the Year awards in Vietnam. Notably, Tilleke & Gibbins was named “Most Responsive International Law Firm” in both jurisdictions—an acknowledgment that underscores the firm’s longstanding commitment to client service. Firm of the Year – Thailand Most Responsive International Law Firm Antitrust/Competition Banking and Finance Employment Energy and Projects Intellectual Property International Arbitration Litigation and Dispute Resolution Real Estate and Construction Taxation Technology, Media, and Telecommunications Honorable Mention: Capital Markets Honorable Mention: Corporate and M&A Firm of the Year – Vietnam Most Responsive International Law Firm Employment Intellectual Property International Arbitration Litigation and Dispute Resolution Technology, Media, and Telecommunications The IHC Firms of the Year rankings are determined through responses from thousands of in-house counsel and corporate decision-makers in Asia and the Middle East. Tilleke & Gibbins is honored to receive this recognition from the clients and peers it serves across the region.
April 18, 2025
Asian Legal Business has released its 2025 “Employer of Choice” rankings, and Tilleke & Gibbins has once again secured top honors as a premier employer in the legal sector in both Thailand and Vietnam. This marks the 13th consecutive year that the firm has been recognized as Employer of Choice in Thailand and the 11th time in Vietnam.
April 1, 2025
Tilleke & Gibbins has been recognized in 10 categories at the 2025 Thailand Law Firm Awards from Asia Business Law Journal (ABLJ). These awards celebrate the country’s top law firms across key practice areas, as well as a separate category for the best overall firms. This year, Tilleke & Gibbins was named a leader in: Best Overall Law Firms Aviation Competition & Antitrust Data Compliance & Cybersecurity ESG (Environmental, Social, and Governance) Healthcare & Life Sciences IP Prosecution Private Equity & Venture Capital Shipping & Maritime Technology, Media & Telecoms The awards were determined by ABLJ’s research team, which evaluates law firms based on their recent work, client feedback, and standing in the market. ABLJ is a legal publication in Asia, providing in-depth coverage of legal and business developments across the region. Its annual Thailand Law Firm Awards highlight excellence in legal practice and industry leadership. For more details and the full list of winners, please visit the Asia Business Law Journal website.