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Regulatory Affairs

Regulatory Affairs

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

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

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

September 28, 2026
On September 15, 2026, the Thai Food and Drug Administration (Thai FDA) opened a public consultation period on the principles of a proposed Ministry of Public Health (MOPH) notification establishing specific Good Manufacturing Practice (GMP) requirements for foods derived from cultured animal cells. The proposal would build on Thailand’s existing safety assessment framework by proposing GMP requirements specifically tailored to the production of cultivated meat. As cultivated meat advances toward commercial production, its unique manufacturing processes present food safety challenges involving aseptic conditions, starting cell quality, culture media, and specialized equipment. Thailand’s Food Act B.E. 2522 (1979) provides the legal basis for regulating food manufacturing, but no GMP requirements specifically tailored to cultivated meat have been issued under it. The proposed framework aims to address this gap. The Thai FDA has not yet released a complete draft notification, so the proposed requirements outlined below may change before adoption. However, they indicate the direction the regulator intends to take, and companies preparing to enter the Thai market can use them now to anticipate their compliance obligations. What Is Cultivated Meat? Cultivated meat, also known as cell-based food or cell-cultured meat (and referred to in the proposed notification as food derived from cultured animal cells), is produced by cultivating animal cells rather than raising and slaughtering animals through conventional meat production. The process generally begins with the selection of animal cells or stem cells, which are cultivated in an appropriate culture medium within a bioreactor to promote cell growth and proliferation. Scaffolding materials or other techniques may subsequently be used to develop cells into tissue or other forms suitable for consumption. Unlike conventional meat production, this process introduces specific food safety considerations relating to starting cells, culture media, production substances, contamination controls, and potential residues in the final product. Thailand’s Safety
September 9, 2026
On August 5, 2026, the Consumer Case Division of Thailand’s Civil Court rendered a judgment in a case involving a beauty clinic that advertised acne scar treatments using claims that the clinic was operated by a specialist physician and that the treatment, allegedly involving stem cell technology, could permanently remove acne scars. The plaintiff brought a claim against both the physician-owner and the clinic company, alleging that the advertisements were false and induced her to purchase the treatment. The court found that the clinic was liable for the false representations and that the physician-owner, as both the authorized director of the company and the medical practitioner who provided treatment, was jointly responsible. Although the plaintiff could not fully prove all damages claimed, the court awarded compensation of THB 20,000, together with interest. While the judgment arose from a consumer protection dispute, it serves as a valuable reminder that medical facility advertisements in Thailand are regulated and may expose clinics and healthcare providers not only to regulatory enforcement but also to civil liability from patients who rely on misleading promotional claims. Regulatory Framework Governing Medical Facility Advertisements Medical facility advertising in Thailand is governed by the Medical Facility Act B.E. 2541 (1998), as amended by the Medical Facility Act (No. 4) B.E. 2559 (2016). The principal secondary legislation is the Department of Health Service Support (DoHSS) Notification Re: Rules, Procedures, Conditions, and Fees for an Advertisement or Publication Concerning a Medical Facility, which came into force on November 25, 2019. Under this notification, “advertising” includes any act, by any means, that causes members of the public to see, hear, or otherwise become aware of a message, sound, or image for the commercial benefit of a medical facility. This broad definition covers not only traditional media but also clinic websites, social
September 9, 2026
On June 30, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 11 of 2026 on Food Packaging, which expands the list of approved food-contact substances and recognizes a broader range of permissible functions for those substances. The new regulation, which revokes BPOM Regulation No. 20 of 2019, reflects developments in packaging technology and materials science. Although the new regulation provides more advantages to business actors by adding more food contact substances to the approved list for use in food packaging, there are more stringent rules and restrictions for testing. One of the most significant changes is a comprehensive migration-testing framework that sets out requirements for packaging materials, testing conditions, food simulants, and specific migration limits. Overall and Specific Migration Under BPOM Regulation No. 20 of 2019, migration requirements were primarily set out within the lists of approved food-contact substances and packaging materials. BPOM Regulation No. 11 of 2026 instead expressly requires packaging materials that come into direct contact with food to meet both overall and specific migration limits. These are defined as follows: Overall migration: The total quantity of all substances that migrate from the packaging, regardless of whether the substances are hazardous or nonhazardous to health. Specific migration: The quantity of a particular identified substance known to be hazardous to health that migrates from the packaging. Stricter Limits on Heavy Metals The overall migration limit for plastic packaging remains unchanged under both regulations at 60 mg/kg or 10 mg/dm². However, the new regulation introduces significant changes to the regulation of heavy metals. Under the 2019 regulation, four heavy metals—lead, cadmium, chromium VI, and mercury—were subject to a single combined limit of 1 mg/kg. The 2026 regulation, however, requires each heavy metal to meet its own individual specific migration limit, adds arsenic as
September 4, 2026
Blind boxes and collectibles have become increasingly popular, driven by the excitement of not knowing which character or design will be revealed until the package is opened. While most visible in the art toy market, the same concept is also used in the food industry. Confectionery, snacks, and other food products are sometimes sold with toys, character figures, cards, or other collectibles. A package might, for example, contain one of ten possible characters, with consumers knowing that an item is included but not which one they will receive. Some collections may also feature rare or “secret” items. For food businesses, however, adding a randomized toy or collectible involves more than a marketing decision. The food, the nonfood item, and the randomized mechanism may each raise different regulatory considerations in Thailand. Thai FDA Requirements for Nonfood Objects Packaged with Food The main food regulatory consideration is Ministry of Public Health Notification No. 310 B.E. 2551 (2008), which regulates food packaged together with things or objects that are not food. Under Notification No. 310, certain nonfood objects may be packaged together with food where they fall within specified exceptions, including objects that serve the following purposes: Maintaining the quality or standard of the food, such as a desiccant or oxygen absorber; Serving as a seasoning or as part of food preparation, such as chili powder sachets or seasoning sachets contained in instant noodle packages; or Functioning as an eating or food-preparation utensil, such as a spoon or fork included with instant noodles. Other nonfood objects that do not fall within these categories generally should not be placed inside the food container together with the food. Where a toy, collectible, or other nonfood object is intended to be sold together with a food product, businesses should therefore carefully consider the nature of
AWARDS & RANKINGS
September 23, 2026
Tilleke & Gibbins has received 14 nominations for the Asialaw Awards 2026. The nominations span jurisdiction-level, practice-area, and individual categories across the region. At the jurisdiction level, Tilleke & Gibbins has been shortlisted in three categories: Cambodia Firm of the Year Laos Firm of the Year Thailand Firm of the Year The firm has also been shortlisted for four regional practice awards: Aviation and Shipping Firm of the Year Corporate and M&A Firm of the Year Dispute Resolution Firm of the Year Technology and Telecommunications Firm of the Year Seven individual nominations recognize lawyers from the firm’s offices in Laos, Thailand, and Vietnam: Prisna Sungwanna, Laos Female Lawyer of the Year Pimvimol Vipamaneerut, Thailand Female Lawyer of the Year Tram Ngoc Bich Nguyen, Vietnam Female Lawyer of the Year John Frangos, Aviation and Shipping Lawyer of the Year, Dispute Resolution Lawyer of the Year Pongpalin Chantrapirom, Dispute Resolution Rising Star of the Year Chusert Supasitthumrong, Labour and Employment Lawyer of the Year The winners will be announced at an awards ceremony in Kuala Lumpur on November 5, 2026. For more information on the Asialaw Awards 2025 and to browse a full list of the nominees, please visit the Asialaw website.
May 11, 2026
Tilleke & Gibbins has continued to show excellent performance in the recently released Benchmark Litigation 2026 rankings for dispute resolution firms in the Asia-Pacific region. The rankings include two jurisdictions where Tilleke & Gibbins is active: Thailand and Vietnam. Firm Rankings A full summary of the firm’s rankings is provided below: Thailand Commercial & Transactions – Tier 1 Government & Regulatory – Tier 1 Labor & Employment – Tier 1 Intellectual Property – Tier 1 Trade & Customs – Tier 2 Vietnam Commercial & Transactions (Foreign Firms) – Tier 1 Intellectual Property (Foreign Firms) – Tier 1 Labor & Employment (International Firms) – Highly Recommended (top tier awarded in this category) White Collar Crime – Recommended (top tier awarded in this category) Energy & Construction (Foreign Firms) – Tier 2 International Arbitration – Tier 2 Individual Rankings The 2026 edition also recognizes 12 Tilleke & Gibbins lawyers in Thailand—more than any other firm in the jurisdiction—and four in Vietnam. Thailand Alongkorn Tongmee – Trade & Customs Chitchai Punsan – Commercial & Transactions Chusert Supasitthumrong – Labor & Employment John Frangos – Commercial & Transactions Noppramart Thammateeradaycho – Shipping Nuttaphol Arammuang – Intellectual Property Piyawat Vitooraporn – Commercial & Transactions Pongpalin Chantrapirom – Commercial & Transactions Suebsiri Taweepon – Intellectual Property Suruswadee Jaimsuwan – Commercial & Transactions Thawat Damsa-ard – Commercial & Transactions Tiziana Sucharitkul – Commercial & Transactions, Government & Regulatory Vietnam Duc Anh Tran – Commercial & Transactions Linh Duy Mai – Intellectual Property Loc Xuan Le – Intellectual Property Tu Anh Tran – Commercial & Transactions Benchmark Litigation’s annual research is based on interviews with dispute resolution specialists and clients, as well as analysis of recent casework and market developments. To view the full results, please visit the Benchmark Litigation websites for Thailand and Vietnam.