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Regulatory Affairs

Regulatory Affairs

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

David Mol

     +855 23 964 210

     [email protected]

Jay Cohen

     +855 23 964 210

     [email protected]

Wongrat Ratanaprayul

     +6221 2971 8099

     [email protected]

Irene Djalim

     +6221 2971 8001

     [email protected]

Alan Adcock

     +66 2056 5871

     [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]

OVERVIEW

Specialized support from experts who know your industry.

Our dynamic regulatory affairs group is built on decades of practice in the region and is committed to keeping pace with discovery and innovation. Our client teams are led by experienced attorneys and specialized practitioners and include, as appropriate to the client and its industry, pharmacists, agricultural consultants, and other regulatory specialists. We guide our clients through the layers of formal and informal rules, policies, and procedures, and help our clients forge constructive relationships with regulatory authorities.

We assist with the registration and prosecution of pharmaceuticals, biotechnology 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.

Our practice spans the following disciplines:

  • Clinical trials and consumer testing
  • Registration with public health authorities
  • FDA import, export, and manufacturing licenses
  • Crop care registration with agricultural regulatory authorities
  • Animal, aquatic, and hazardous substance registration
  • Import, export, and manufacturing licenses
  • Holding licenses
  • Regulatory compliance and maintenance
  • Labeling and advertising clearance
  • Intellectual property
Case Studies
Regional | Life Sciences | Regulatory Affairs

Market Entry for Plant-Based Meat Substitutes Foodtech Company

Assisted a world-leading foodtech innovator known for developing plant-based meat substitutes in establishing a presence and a market for their products in Indonesia and Thailand, including extensive advice on food product registration with local FDAs.

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Experience

  • Acted as counsel to a major pharmaceutical company, which representation included 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.
  • Represented a world-leading pharmaceutical company on regulatory due diligence in their spin-off of high revenue product lines (i.e., over-the-counter antihistamines, cough relief syrups, tablets and elixirs) to another major pharmaceutical company.
  • Retained to advise an American biotechnology manufacturing company on Southeast Asian drug approval for several of their bespoke personal care and pharmaceutical products.
  • Acted for a Canadian standards and regulatory consultancy firm in conducting a regulatory landscape project on anti-microbial processing aids for the food industry in four jurisdictions in Southeast Asia. Our Regulatory Affairs teams across our offices advised the client on applicable government agencies, regulations, regulatory submissions, and other requirements for their product. The invaluable information we provided prompted the client to retain our teams for a subsequent regulatory landscape project on nutraceuticals.
  • Assisted a European medical device and pharmaceutical company active in over 50 countries to successfully obtain VIPRI (Vietnam Intellectual Property Research Institute) opinions that two foreign-produced products imported into Vietnam were infringing.
  • Assisted a global pharmaceutical company, with registration of and regulatory approval for its drugs with the Myanmar Food and Drug Administration (FDA), while simultaneously working to stem the flow of counterfeit drugs that were being sold in the Myanmar market.
  • Acted as lead Thai counsel to a major pharmaceutical company on various regulatory affair matters including, 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.
  • Seconded a lawyer to the Vietnam subsidiary of a U.S.-based global medical devices and consumer products company to fill their in-house counsel position. Our secondee was in charge of legal matters for all of the client’s subsidiaries and representative offices in Vietnam in relation to their pharmaceuticals, consumer goods, and medical devices operations
  • 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.
  • Assisted a multinational confectionery company with registration of various chocolate and mint products in Thailand and Vietnam, and provided advice on food labeling requirements, classification of food products, food additive regulations, and parallel import of foods.

PROFESSIONALS

RELATED INSIGHTS

May 8, 2026
Thailand has liberalized its wine import regime, allowing, for the first time, multiple importers to bring in and distribute the same wine brands. On March 27, 2026, the Ministry of Finance issued the Ministerial Regulation on the Importation of Alcoholic Beverages (No. 3) 2026, which waives the requirement to appoint a sole authorized agent for alcoholic beverages to be specified in notifications from the Excise Department. The Excise Department has already issued its first such notification, expressly exempting wine and sparkling wine made from grapes from the sole agent requirement. For all other types of alcoholic beverages (e.g., beer, tequila, spirits) the sole agent requirement remains in force, and applicants for importer licenses must provide evidence of exclusive distributorship issued by the manufacturer or brand owner. The exemption may be extended to other alcoholic beverage categories through future Excise Department notifications. Implications for Competition and Tourism The reform allows multiple importers to bring in and distribute the same wine brand without routing through the brand owner’s designated exclusive importer, reducing monopolization and boosting competition. Excise Department Director-General Pornchai Thirawet noted that wine was chosen as the starting point because implementation is straightforward in this case and because domestic wine prices remain high—with increased competition expected to exert downward pressure on prices. More broadly, the reform is intended to lower market entry barriers, expand supply, and make wine more accessible to Thai consumers, while supporting Thailand’s position as a regional tourism hub. Product Quality Control and Loss of Sole Agent Accountability Under the previous framework, the designated importer bore full responsibility for the proper storage, handling, and distribution of wine and sparkling wine from importation to final sale. This arrangement helped ensure that products were maintained under appropriate conditions, including temperature control, light exposure, and humidity management, to preserve quality
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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
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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
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March 30, 2026
In response to an emerging crisis on food safety, the government of Vietnam promulgated Decree No. 46/2026/ND-CP (Decree 46) on January 26, 2026, and Resolution No. 66.13/2026/NQ-CP (Resolution 66.13) on January 27, 2026, setting out a number of substantive changes to the procedure and strict requirements for the declaration, registration, and importation of food products. Both instruments took effect upon issuance. However, shortly after they entered into force, food businesses encountered significant implementation challenges, particularly with respect to state inspection procedures at the customs clearance stage for imported products. In response, the government issued Resolution No. 09/2026/NQ-CP (Resolution 09) on February 4, 2026, temporarily suspending Decree 46 and Resolution 66.13 until a new effective date of April 16, 2026. Continued Suspension of Implementation of Decree 46 and Resolution 66.13 After considering feedback gathered by the Ministry of Health from food businesses and other stakeholders during the suspension period, the Vietnam Government Office issued a notice on March 20, 2026, agreeing to extend the suspension until the issuance of an amended Law on Food Safety and its guiding decree. Following this notice, on March 22, 2026, the Ministry of Health prepared a draft resolution to implement the notice and replace Resolution 09. Under the draft resolution, the effectiveness of Decree 46 and Resolution No. 66.13 would continue to be suspended until the amended Law on Food Safety takes effect, except for the provisions under Resolution 66.13 allowing flexibility in documents evidencing product efficacy, which would take effect on April 16, 2026, and remain effective until the Law on Food Safety is replaced (but not later than February 28, 2027). Accordingly, for products subject to the registration declaration procedure, such as health supplements, efficacy may be substantiated by either (i) scientific evidence supporting the declared function and effects of the product
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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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