You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

July 24, 2026

Thailand’s Licensing Facilitation Act 2026: A Step Forward for Regulated Industries

Subscribe to Updates

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 This kind of overlap is often cited to argue for a “regulatory guillotine”—a systematic review to cut outdated or duplicative rules that slow investment and business activity.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 that spend time on regulatory submissions are considerable. Today, a single product often has to clear several independent approval tracks, each with its own dossier, timeline, and reviewing authority. For example:

  • A can of caviar imported for sale in Thailand currently needs a food product license from the Thai FDA, a CITES permit (caviar is typically derived from sturgeon species listed under that convention), and an import license for fishery products from the Department of Fisheries.
  • Software as a medical device (SaMD) or software in a medical device (SiMD) that uses artificial intelligence may require registration with the FDA’s Medical Device Control Division, approval tied to the National Broadcasting and Telecommunications Commission for any wireless or telecommunications components, and certification from the Thai Industrial Standards Institute (TISI) for applicable product standards.

In each case, the regulatory affairs burden is not just the number of approvals but the effort of sequencing them—coordinating overlapping document requests, reconciling different processing times, and managing the risk that a delay at one agency stalls the whole launch. Collapsing those related approvals into a single main license, backed by a shared information system, is precisely the friction the super license is designed to remove.

However, the mechanism only applies once the cabinet designates an activity as eligible by the royal decree announced in the Government Gazette. It is reasonable to expect that lower-risk, high-volume activities will be prioritized ahead of products that have been supervised by various agencies, such as food and beverages. Businesses should also keep in mind that the super license is aimed at related and ancillary approvals; it is unlikely to displace the core product registration that sits at the heart of FDA oversight. In practice, then, the near-term benefit may be greatest for products whose primary approval is straightforward but which are held up by a cluster of secondary permits.

Firmer Service Standards from Regulators

The Licensing Facilitation Act 2026 also introduces clearer service standards for government agencies. Any agency that receives a written inquiry, suggestion, or opinion about its licensing or service functions must now respond within 15 days. Separately, once a license application is submitted, officers must check it against the relevant public manual immediately, record any deficiencies together with a deadline for correction, and have both the officer and the applicant sign the record—a requirement that now applies broadly across all public services rather than just to a handful of registries.

For businesses that regularly deal with agencies, such as the FDA, where applications can face repeated and open-ended requests for extra documents, these firmer timelines should bring welcome predictability. A single, signed record of deficiencies with a fixed correction deadline should help curtail the supplementary requests that can extend registration timelines and make launch dates hard to plan.

Nevertheless, the law’s separate deemed-approval mechanism—under which silence past the published timeline can count as approval—is confined to activities that do not pose a high risk to public health, safety, or the environment. Many life sciences products, drugs and higher-risk devices among them, are unlikely to fall within that carve-out, so the more tangible gains for this sector will come from firmer timelines and greater transparency rather than from automatic approvals.

Outlook

The Licensing Facilitation Act 2026 is a meaningful step toward reducing the overlapping licensing burden that has long shaped regulatory strategy for life sciences and other regulated-product businesses in Thailand. How much it delivers in practice will depend on the royal decrees that designate which activities qualify for the super license, the public manuals each agency issues, and how quickly regulators such as the FDA, Department of Fisheries, TISI, and others adapt to the shared-information and single-application model.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

June 19, 2026
For the first time, Thailand’s Food and Drug Administration (FDA) has published a consolidated list identifying all substances that have successfully passed its novel food safety evaluation process. The list is a step forward in regulatory transparency, but it also highlights a feature of the Thai regime that food companies often overlook: each approval is tied exclusively to the company that applied for it. A substance’s appearance on the list does not give other companies the green light to use it. This article examines the structure of Thailand’s novel food approval framework, the implications of applicant exclusivity, and the strategic choices it requires of food companies looking to bring novel ingredients to the Thai market. Thai FDA Food Safety Evaluation Framework Notification No. 376 of the Ministry of Public Health requires novel food substances to undergo a food safety assessment, with an exemption only for novel foods manufactured exclusively for export. The framework also encompasses “foods that do not qualify as novel foods” but which present characteristics warranting a safety evaluation, such as differing quality standards, increased serving sizes, or applications in specific food categories, where such changes affect consumption levels, nutritional value, or consumer safety. The recently published list of foods that passed the safety evaluation by the Thai FDA is structured by substance category and identifies the approved company (domestic manufacturer or importer), country of origin, substance name and trade name, approved purpose of use, and date of the Thai FDA’s approval notification certificate. A notable feature of Thailand’s novel food regime is that the approval result is tied exclusively to the company that submitted the application. Publication of the consolidated list does not constitute a general authorization to use the approved substances. The Thai FDA’s approval certificate specifies the approved conditions of use and the requirements
Read More
June 17, 2026
Thailand’s new labeling requirements for medical devices, which include for the first time a unique device identification (UDI) requirement for software as a medical device (SaMD), take effect on June 20, 2026. The Notification of the Ministry of Public Health regarding Criteria, Methods, and Conditions on Labeling and Instructions for Use for Medical Devices 2025, which replaces a similar notification from 2020, was published in the Government Gazette on December 22, 2025. To ensure clarity, modernity, and patient safety, the regulation requires domestic manufacturers and importers to provide labels and instructions for use (IFU) that are clearly legible, complete, and free of false or misleading claims. It also permits IFU to be provided in electronic format, such as via QR codes, websites, or other digital channels—directly relevant to SaMD, where physical labels are impractical and electronic presentation is the natural medium. The notification distinguishes two categories for labeling language. Home-use medical devices (for lay users outside healthcare facilities) must have labels and IFU in Thai. Professional-use medical devices may display labels and documentation in either Thai or English. This distinction is significant for SaMD developers: software intended for clinical professionals may use English-language interfaces and IFU, while consumer-facing health applications must provide Thai-language content. Labeling and UDI Requirements Labels and IFU must include, at a minimum: Product name and intended purpose Quantity or volume Name and address of domestic manufacturer or importer Thai FDA approval number Lot, version, or serial number Manufacturing date and expiry date For SaMD, the version number requirement is particularly relevant. The regulation also mandates display of a UDI code for SaMD in risk category 2 (moderate-risk), category 3 (moderate- to high-risk), and category 4 (high-risk), according to Thailand’s medical device risk classification system (which complies with the ASEAN Medical Device Directive and the EU
Read More
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.
Read More
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
Read More