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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

July 24, 2026
For businesses in Thailand’s regulated industries, the problem of “too many licenses” is one of the most familiar hurdles to getting a product to market. Take a simple example: importing the materials necessary to sell teriyaki chicken skewers. To legally do this, a business may need approvals from several different agencies—separate permits for the chicken (Department of Livestock Development), the dipping sauce (Thai FDA), the wooden skewers (Department of Forestry), and other ingredients, each under a different authority. This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity. The Facilitation of Licensing and Public Service Consideration Act B.E. 2569 (2026) (Licensing Facilitation Act 2026) is Thailand’s most significant response yet to that concern. This article looks at the Facilitation Act 2026 through a life sciences and regulatory affairs lens—what it may mean for the manufacturers, importers, and distributors of food, drugs, medical devices, cosmetics, and similar products who routinely deal with several regulators to bring a single product to market. The Super License: One Approval Standing in for Many The reform with the clearest potential for regulated-product businesses is the law’s “super license” mechanism, referred to as a “main license” in the statute. Once a business obtains the main license for a regulated activity, it is automatically deemed to hold all related sublicenses issued by other agencies for that same activity, provided the activity has been designated as eligible in the Government Gazette. The Licensing Facilitation Act 2026 also creates a central application center, allowing applicants to submit a single application and pay all relevant fees at one point of contact, with the center routing the application to each agency through a shared information system. The potential benefits of this for businesses
July 13, 2026
Indonesia’s Halal Product Assurance Agency (BPJPH) has issued new regulations establishing clearer procedures for imposing administrative sanctions on businesses that violate halal product assurance requirements. BPJPH Regulation No. 2 of 2026 on the Imposition of Administrative Sanctions for Violations of Halal Product Assurance Implementation, issued on June 5, 2026, strengthens Indonesia’s halal compliance framework, as mandated under Law No. 33 of 2014 on Halal Product Assurance and Government Regulation No. 42 of 2024 on the Implementation of Halal Product Assurance. BPJPH Regulation No. 2/2026 also supports the upcoming mandatory halal compliance deadline of October 17, 2026, which will apply to a broad range of products and services, including imported food and beverages, slaughtering products and services, natural and quasi-drugs, health supplements, cosmetics, chemical and genetically engineered products, clothing and accessories, household goods, prayer equipment, stationery, and class A medical devices. Scope BPJPH is authorized to impose administrative sanctions for violations of halal product assurance requirements committed by businesses, halal inspection agencies (LPH), halal auditors, halal product process companion institutions (lembaga pendamping PPH), and halal product process companions (pendamping PPH). The head of BPJPH has authority to determine, cancel, or amend the imposition of administrative sanctions, including upon receipt of objections. This authority covers revocation of Halal Certificates (including foreign halal certificate registration numbers), withdrawal of goods from circulation, freezing of LPH operations, freezing of halal product process companion institutions, revocation of PPH companion institution registration numbers, revocation of halal auditor registration numbers, and revocation of LPH accreditation status. Administrative Sanctions Businesses may be subject to any of the following administrative sanctions: Written warning; Administrative fine; Revocation of the halal certificate, including revocation of foreign halal certificate registration numbers; and Withdrawal of goods from circulation. The regulation sets out the types of violations that may trigger these sanctions, with each
July 1, 2026
Obtaining marketing authorization is a fundamental requirement for bringing pharmaceutical products to the Thai market. Companies must navigate the Thai Food and Drug Administration’s registration procedures while also complying with post-approval pharmacovigilance obligations, licensing requirements for manufacturing and importation, data protection rules, and other regulatory requirements. This guide provides an overview of Thailand’s regulatory framework for pharmaceutical marketing authorization, including available registration pathways, review timelines, application fees, postmarketing surveillance obligations, licensing requirements, exemptions, data exclusivity, freedom of information, and parallel import considerations. It is intended as a practical reference for pharmaceutical companies, regulatory affairs professionals, and others involved in bringing medicinal products to the Thai market. Download the guide below for a concise overview of the current requirements and procedures governing pharmaceutical marketing authorization in Thailand.
June 24, 2026
Patent enablement requirements are provided under Article 102 of Vietnam’s Law on Intellectual Property (IP Law). In particular, a patent specification must “fully and clearly disclose the nature of the invention to such an extent that, based on the specification, a person having ordinary skill in the relevant art can implement the invention.” In pharmaceutical and biotechnology patents, this requirement is more complicated and subject to more rigorous assessment. The Patent Examination Guidelines (Guidelines) of the Intellectual Property Office of Vietnam (IP Office) were amended in March 2026 to introduce Annexes III and IV for the pharmaceutical and biotechnology sectors, in which Annex III provides detailed guidelines on the assessment of specification requirements. These amendments were made under a project for strengthening capacity in industrial property examination between the Japan International Cooperation Agency (JICA) and the IP Office. Annex III provides detailed instructions on how examiners assess enablement in a pharmaceutical or biotechnology application, and offers examples of acceptable and unacceptable descriptions with regard to the enablement aspect. Enablement Requirements in Pharma and Biotech Patents Article 12.7 of Circular 10/2026/TT-BKHCN (Circular 10) adds to the requirements of Article 102 of the IP Law that the description must demonstrate the novelty, inventive step, and industrial applicability of the technical solution. For pharmaceutical composition subject matters, Article 12.9 of Circular 10 sets out that the description must present the results of clinical trials and/or the pharmacological effects of the claimed pharmaceutical composition, and must include at least the following information: Substance/mixture used. Testing method (system) employed. Information on the test results. Correlation between the pharmacological effects obtained from the tests and the application of the pharmaceutical product in the prevention, diagnosis, and treatment of diseases. The Guidelines note that pharmacological study results should be presented in a quantified manner, and pharmacological
AWARDS & RANKINGS
December 12, 2025
Tilleke & Gibbins has maintained its strong market position in the newly released Chambers Asia-Pacific 2026 rankings, with six Band 1 honors in core practices and consistently strong performance across the entire region. In addition to the exceptional practice-area rankings, 33 lawyers were recognized across 11 practice areas.
December 1, 2025
Tilleke & Gibbins is pleased to announce that the firm has been honored with two awards at the 2025 Lexology Index Awards in London, this time picking up both the Thailand and Vietnam Country Awards. Formerly known as the Who’s Who Legal Awards, the Lexology Index Awards celebrate outstanding achievements by firms and individuals identified through Lexology’s extensive global research process. Tilleke & Gibbins’ continued success in this forum reflects the exceptional expertise and dedication of its team, whose commitment to delivering the highest caliber of legal services continues to set a benchmark in the industry. The firm extends its gratitude to its talented professionals and valued clients for their continued trust and support. A full list of the winners of the 2025 Lexology Index Awards is available on the Lexology website.
November 20, 2025
Tilleke & Gibbins is pleased to share that Asia Business Law Journal (ABLJ) has released its A-List of Thailand’s Top 100 Lawyers and its exclusive Legal Icons list for 2025. This year, Darani Vachanavuttivong has again been named a Legal Icon, recognizing her as one of the most distinguished professionals in Thailand’s legal community. In addition, nine other Tilleke & Gibbins lawyers have been named among Thailand’s Top 100 Lawyers. The full list of honorees is: Alan Adcock Charunun Sathitsuksomboon Chusert Supasitthumron (new ranking) Athistha (Nop) Chitranukroh Darani Vachanavuttivong (Legal Icon) Kobkit Thienpreecha Nuttaphol Arammuang Pimvimol (June) Vipamaneerut Thawat Damsa-ard Tiziana Sucharitkul The ABLJ A-List is compiled through extensive research, including nominations and feedback from in-house counsel worldwide and international law firm partners who focus on Thailand. The editorial underscores the demand for lawyers with unmatched expertise, a dedication to quality, and a proven ability to deliver strategic, innovative solutions. To view the full list and the accompanying editorial analysis, please visit the ABLJ website.