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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

March 20, 2026
Myanmar has introduced a comprehensive new regulatory framework for alcoholic beverages that will impose stricter controls on production, distribution, advertising, and sales. On March 7, 2026, the National Defence and Security Council issued a new Excise Law (NDSC Law No. 13/2026), repealing the Excise Act of 1917. The law, which has not yet entered into force, will take effect on a date to be specified in a separate notification—likely within this year. The new Excise Law establishes clearer definitions, introduces multiple categories of excise licenses and permits, and significantly expands prohibitions and compliance obligations for businesses operating in the alcohol sector. Many operational details will be clarified through implementing rules and notifications. Scope and Definitions The new law defines “excise” to cover alcoholic liquor and excisable articles. Alcoholic liquor is broadly defined as any liquid containing more than 0.5% ethyl alcohol, including beer, wine, toddy sap, fermented liquor, and any other liquid declared as alcohol by notification of the relevant ministry, excluding denatured alcohol. Alcoholic liquor is further categorized into country liquor, foreign liquor, and international‑standard domestically produced liquor. Excise Licensing The law also introduces a more detailed licensing regime. The following types of liquor excise licenses are available: Production Production of value-added products Bottling Distribution Sales Other excise‑related businesses designated by General Administrative Department (GAD) notification The GAD will prescribe the licensing fees, requirements, and conditions for each category through notifications issued with the approval of the Ministry of Home Affairs. The GAD may also, with the approval of the Ministry of Home Affairs, prescribe quantities and volumes of alcoholic beverages that may be possessed without a liquor license. No such prescribed quantities have yet been issued. Holders of excise licenses for manufacturing, production of value-added products, or bottling must obtain approval from the relevant government department or
February 26, 2026
Laos’ Food and Drug Department (FDD) has been using a new online registration system for drugs since the beginning of the year. The system, which was implemented following the November 2025 issuance of Notice No. 5960/FDD, became the official pathway for submissions on January 1, 2026. Since that date, paper-based registrations have no longer been accepted. This marks a significant advancement in the digitalization of regulatory processes in Laos. As the online system is now the exclusive platform for registration, renewal, and amendments, companies that have not yet aligned their processes to the new system should act promptly to ensure a smooth transition. To assist with this, the FDD will conduct periodic training sessions on the use of the online registration system, which will be delivered either in person or remotely, depending on operator demand. To start using the system, drug and medical device manufacturers, as well as import-export companies, that have not yet registered must submit a formal request identifying the authorized personnel who will access the platform, after which they will be issued user accounts and access codes. Each request must be accompanied by the company’s enterprise registration certificate (incorporation certificate), a copy of the identity card or passport of each designated user, and a scanned copy of their signature. There is no restriction on the number of users per company, allowing flexibility to meet operational needs. Companies that already hold accounts and access codes from the trial phase may continue using them and may apply for additional accounts if needed. Additional Requirements The new system also introduces a standardized format for drug registration numbers. For example, an import drug registration number such as 06 I 4040/15 will be changed to 06-IM-04040-15, and a domestic drug registration number such as 06 L 4040/15 will be changed to
February 25, 2026
On February 18, 2026, Myanmar’s Ministry of Health issued Order No. 8/2026 announcing the prohibition of electronic smoking devices and related products under the Essential Supplies and Services Law 2012, thus outlawing their use, storage, and trade. The ban covers e‑cigarettes, heated tobacco products, electronic shisha, and all related components and accessories, including devices, parts, batteries, chargers, and flavored liquids (regardless of nicotine content). Prohibited activities include importing, exporting, selling, distributing, possessing, storing, transporting, and using these products, with immediate effect. Regulatory Compliance Businesses and individuals should promptly review their inventories, operations, and commercial arrangements to ensure compliance. Affected products should be withdrawn from the market, and relevant licensing, registration, and reporting obligations should be reviewed. Companies are also advised to update internal compliance procedures and coordinate with relevant authorities as necessary.
January 8, 2026
Thailand’s approach to cannabis regulation has moved quickly from broad access to a medical, prescription‑only system. The latest government regulation classifies the cannabis flower as a controlled herb under the Thai Traditional Medicine Wisdom Act. The latest rules ban advertising and recreational sales, allow sales only to patients with prescriptions (up to 30 days), and require flowers to come from GACP‑certified (Good Agricultural and Collection Practices) farms. More importantly, cannabis dispensaries can only sell to patients presenting valid prescriptions issued by one of seven professions—medical doctors, Thai traditional practitioners, applied Thai traditional practitioners, traditional Chinese medicine practitioners, pharmacists, dentists, and folk healers—consistent with approved clinical indications. Noncompliance risks license suspension or revocation, and criminal penalties of up to one year’s imprisonment or a THB 20,000 fine. The dispensary‑only model that proliferated in Thailand in recent years is expected to end soon, as the rules will push all cannabis dispensaries into medical settings or retail pharmacies. Dispensaries must convert into medical establishments—clinics, pharmacies, or traditional pharmacies—complete with on‑site licensed practitioners as well as budtenders; strong controls for storage, hygiene, odor, and smoke; and facilities for record-keeping. All flowers dispensed or exported must come from GACP‑certified farms. If the government ends dispensaries outright and forces a conversion to clinics or pharmacies, compensation will not be automatic at the outset. As a result, business operators should plan for compliance and repurposing under the Medical Facilities Act, Modern Drug Act, and Herbal Product Act, which regulate medical clinics, modern pharmacies, and traditional medicine pharmacies, respectively. The table below summarizes the required licenses for clinics, pharmacies, and traditional medicine pharmacies selling cannabis flowers in Thailand. Aside from the specific listed licenses, all three types of establishments must also obtain a license to sell a controlled herb (cannabis flowers) from the Department of Thai Traditional
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.