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

November 28, 2017

Thailand Food and Drug Administration Unveils New Official Fees

Subscribe to Updates
Informed Counsel

Higher life expectancy, a growing middle-income population, and the government’s policy of promoting access to medicine are key drivers boosting demand for healthcare-related businesses in Thailand. In 2015, healthcare expenditures accounted for 4.6 percent of Thailand’s GDP, and there is an increasing trend in government budgetary spending in healthcare. Due to these factors, the healthcare market is experiencing strong growth, bringing opportunities in cosmetics, health supplements, medical devices, and pharmaceuticals.

Nonetheless, a major obstacle for these industries is the slow-moving registration process of the Thai Food and Drug Administration (FDA). This registration process is a mandatory prerequisite for introducing new healthcare products to the Thai market.

There are currently thousands of drug registration dossiers under evaluation by the FDA that have been stalled under successive governments. A similar backlog has been found in the process to obtain licenses for moderate- to high-risk medical devices, novel foods, food supplements, and innovative herbal products.

The backlog of pending product approvals hinders industries from competing effectively in the market, and it impacts companies eager to launch their new products in a timely manner. More importantly, from a consumer standpoint, the slow approval process prevents Thais from being able to buy products at lower competitive prices and restricts access to the latest innovative drugs.

Delays in the approval process stem from the fact that the FDA lacks sufficient qualified officers to examine technical dossiers to assess the quality, efficacy, and safety of products. The FDA has difficulty in hiring qualified experts, and there are not enough specialists to handle the ever-increasing number of application dossiers.

Reforming the FDA Approval Process

In order to solve this backlog issue, the prime minister has exercised his power as head of the National Council for Peace and Order (NCPO) by using section 44 of the 2014 interim constitution to issue NCPO Order No. 77/2559 Re: Increasing the Efficiency of the Health Products Approval Process, which was published in the Government Gazette on December 28, 2016. The order directs that the FDA approval process for healthcare products must be reformed. The main implications of the order include the following:

  • The FDA’s product approval timeline must not exceed the time specified in its public manuals, which are handbooks that inform the public about the application procedures, relevant legislation, timelines, and list of documents needed for product registration at the FDA.
  • The FDA will consider the official fee schedule in its approval process. Official fees earned by the FDA will be used as honorariums for reviewers/experts to assess technical dossiers, as well as to improve the approval procedure, as per regulations of the Ministry of Finance. Unlike in the past, official fees earned by the FDA will not be refunded to the Ministry of Finance as government revenue.
  • The FDA will outsource some work, such as onsite inspections and evaluations of technical documents, to external experts of local or overseas agencies, who have been approved by and registered with the FDA.

New FDA Official Fees

The FDA engaged in over 10 meetings with major pharmaceutical companies to discuss the overhaul of its approval process and official fee schedule. Subsequently, the Ministry of Public Health (MoPH) issued MoPH Notification Re: Actual Official Fees in the Approval Process to Be Paid by the Applicant on August 4, 2017. The notification prescribes the highest rates of official fees and actual fees to be paid by applicants, with the highest rates to remain effective for 10 years, and revisions by the FDA allowed in five years.

In the past, the FDA approval process charged only one fee for obtaining a license. The new official fee schedule introduced by the MoPH notification itemizes fees to be incurred for each step of the application process, from filing the application, to dossier evaluation, to obtaining a license.

As of August 4, 2017, an applicant now pays THB 2,500 for filing an application, THB 182,500 for dossier evaluation, and THB 2,000 for obtaining the Marketing Authorization (MA) Drug Product License for a new chemical drug. The MoPH notification also prescribes fees covering the lifecycle of a drug product, including fees for an importation/manufacturing license, a sales license, an advertisement approval license, variations of these licenses, etc. More interestingly, the FDA now charges an hourly consultation fee of THB 500–2,000, depending on the consultation matter.

Healthcare business operators should closely monitor the registration and approval process reforms of the Thai FDA. Although the FDA’s official fees have increased substantially, product owners hoping to bring their new products to the Thai market are likely to benefit greatly from the invigorated registration process that promises drug product approval in a more timely and systematic manner.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

August 20, 2026
As part of its membership in Lex Mundi, Tilleke & Gibbins has released the latest edition of its Guide to Doing Business in Thailand, providing an overview of the legal, regulatory, and commercial considerations for companies establishing or expanding operations in Thailand. The 2026 edition offers practical insight into the country’s business environment, investment framework, and operational requirements. The guide covers a wide range of topics relevant to foreign and domestic investors, including: Investment incentives and promotion schemes Financial facilities and banking regulations Exchange controls and money transfers Import and export regulations Business structures and incorporation options Requirements for establishing a business Operational and compliance considerations Business cessation and insolvency procedures Employment and labor laws Taxation Immigration and visa requirements Prepared by Tilleke & Gibbins lawyers across multiple practice areas, the publication outlines key aspects of doing business in Thailand, including foreign investment restrictions, regulatory compliance obligations, corporate structures, employment requirements, and recent legal and economic developments affecting investors. The publication forms part of Lex Mundi’s Country Guides series, a global collection of jurisdiction-specific reference materials prepared by member firms around the world. Together, these guides help companies evaluate opportunities, compare regulatory environments, and plan international business activities across multiple markets. The full Guide to Doing Business in Thailand 2026 is available through the button below.
Read More
August 10, 2026
On June 17, 2026, Indonesia’s National Agency of Drug and Food Control (BPOM) issued BPOM Regulation No. 10 of 2026 on Nutritional Information on Processed Food Labels. The new regulation, which revokes three previous nutrition labeling regulations, introduces several notable changes affecting food and beverage manufacturers, importers, and distributors. These changes range from updated nutrient reference values and serving-size requirements to the introduction of the Nutri-Level front-of-pack labeling system for certain beverage products. Businesses operating in Indonesia should carefully review these developments and assess their products’ compliance with the new requirements during the transition period. Implementation of the Nutri-Level Labeling System To implement the recently issued decree on Nutri-Level labeling, BPOM Regulation No. 10 of 2026 stipulates the requirements to implement the Nutri-Level labeling system on the front-of-pack. Under the new framework, ready-to-drink beverages, powdered beverages, and liquid or solid concentrates are required to display Nutri-Level labeling on the front label of their packaging. The Nutri-Level labeling system classifies products into color-coded levels A through D based on their sugar, sodium, and total fat content. The applicable Nutri-Level is determined based on the lowest level measured in the assessment of sugar, sodium, and total fat content. For products classified as level C or D, the Nutri-Level label must be accompanied by information on the relevant sugar, sodium, and total fat content per 100 ml of the ready-to-consume product. Products classified as level A or B may either display only the Nutri-Level designation or display the Nutri-Level together with the relevant nutritional information per 100 ml. Minimum Vitamin and Mineral Content Required for Declaration BPOM Regulation No. 10 of 2026 introduces a stricter threshold for the declaration of vitamins and minerals in the nutritional value information section (ING). Vitamins or minerals may only be declared if they are present at a
Read More
August 10, 2026
The drug registration process in Vietnam will be simplified, particularly for foreign applicants, following the recent issuance by Vietnam’s Ministry of Health (MOH) of a new circular that is expected to reduce administrative hurdles. Circular No. 32/2026/TT-BYT on the registration of drugs and medicinal ingredients (Circular 32) was issued on July 29, 2026, and will take effect on October 1, 2026, replacing Circular No. 12/2025/TT-BYT. Key provisions of the new circular are discussed below. Five-Year Data Exclusivity and Five-Month Public Disclosure Framework Circular 32 updates data protection guidelines by explicitly referencing Article 128 of the amended Intellectual Property Law, which sets out that new drugs supported by clinical trial data submitted for the first time will be granted a five-year data exclusivity period from the date of the initial marketing authorization (MA) approval. Subsequent applications that rely on the originator’s protected data will not be eligible for approval from the date of submission of the originator’s registration dossier until five years after the first MA is granted. Furthermore, in accordance with the new regulations, the regulatory authority must publicly disclose information on subsequent applications five months before the granting of MA, providing originator companies with an opportunity to exercise and enforce their intellectual property rights. Simplified Requirements for Foreign Legal Documents Circular 32 expands the circumstances under which legal documents issued by foreign authorities are exempt from consular legalization and authenticity verification requirements. Specifically, such documents may be exempt if the Drug Administration of Vietnam (DAV) is able to verify their authenticity directly through official electronic means, including written confirmation or email correspondence sent directly to the MOH by the competent foreign authority, or publicly accessible English-language databases maintained by recognized foreign regulatory authorities. In addition, the new circular permits the submission of electronic notarized copies of legal documents
Read More
July 24, 2026
As food innovation continues to accelerate, manufacturers are increasingly introducing ingredients derived from new sources, produced using novel technologies, or lacking a significant history of human consumption. While these innovations create new opportunities for the food industry, they also raise important questions regarding consumer safety. For this reason, many jurisdictions, including Thailand, the European Union, Australia and New Zealand, Canada, and Singapore, require a premarket safety assessment for novel food ingredients before they can be placed on the market. The objective of this assessment is to ensure that each ingredient is safe for its intended use and level of consumption, does not present toxicological, allergenic, microbiological, or nutritional concerns, and will not mislead consumers. Scientific authorities typically evaluate the ingredient’s identity, manufacturing process, composition, specifications, anticipated dietary exposure, toxicological information, nutritional impact, and history of use before determining whether it can be marketed. Against this background, the Thai Food and Drug Administration (FDA) recently took an important step toward improving regulatory transparency by publishing, for the first time, a consolidated public list of substances that have successfully completed the Thai FDA’s safety assessment process, including substances determined to be novel foods and those determined not to fall within the novel food category. The list identifies the approved substances, the corresponding manufacturers or importers, approval dates, and the approved conditions of use. Although the publication does not change the existing legal framework governing novel food approvals, it provides businesses with greater visibility into the Thai FDA’s regulatory precedents and the types of substances that have previously been accepted through the safety assessment process. The full announcement is available on the Thai FDA’s website. As the list is now publicly available, it also provides useful insight into the types of substances that have successfully completed the Thai FDA’s safety assessment process.
Read More