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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

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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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
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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
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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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