Legal & Regulatory > Thailand

On February 19, 2019, by amending the Narcotics Act B.E. 2522, Thailand caught the cannabis industry by surprise and became the first Asia-Pacific country to legalize medicinal cannabis. While hemp had been approved for use in industry since 2018 (see here), the amendment of the Narcotics Act B.E. 2522, providing for a Thai FDA registration pathway for medicinal cannabis, was largely unexpected.     While the amendments create the foundation for a cannabis industry in Thailand, the true viability and future…

Dealing with the COVID-19 pandemic has taken top priority for almost every country in the world. In Thailand, even though the strength of the country’s health security measures has been ranked sixth-best globally, COVID-19 has hit hard, and the number of confirmed cases is steadily increasing each day.   In the early stages of the outbreak in January 2020, only passengers who had visited mainland China were subject to close monitoring by communicable disease control officers. By late February, South…

Biosimilars and biologics in Thailand – a legal guide. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? No. At present, a “biosimilar” is not the same as a generic drug. Previously, some biological marketing authorization licenses were obtained by using the same registration pathway of generic…

An intro to the legal situation for orphan drugs and rare diseases in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99.   1. What is the definition of Rare Diseases in your country? Neither the Ministry of Public Health in Thailand (MoPH) nor the Thai Food and Drug Administration (Thai FDA) has prescribed a definition for “rare diseases.” However, the…

The low-down on the situation regarding cannabinoid drugs, medicinal cannabis and opioid drugs in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? For the purpose of this chapter, cannabinoid drugs are drugs containing a cannabinoid, which may be extracted and purified from a cannabis plant or synthesized by other…

Keen to learn more about regulatory reforms in Thailand? Read on! Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. Are there proposals for reform or significant change to the healthcare system? The Patent Act The Patent Act is currently under review and final revision by the Department of Intellectual Property, and is expected to be passed soon. The…

A brief overview of the situation regarding patents & trademarks in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? Patent The “subject matter” contained in a patent application may be patented if the following requirements are met: Novelty: Before the filing date, the subject matter must…

The legal framework for product liability in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? The laws of Thailand provide for civil, criminal, and administrative liabilities. Fundamentally, product liability is recognized as part of sales and contract law wherein the seller shall be liable to the buyer for…

All legal aspects surrounding traditional medicines and OTC products in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In April 2019, the Thai FDA published and implemented the Herbal Product Act. This is now the main act regulating herbal or traditional medicine in…

The key facts about marketing, manufacturing, packaging & labeling, advertising in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Pharmaceutical Products The authorization processes for the marketing of new drugs, biologics, over-the-counter medications, and other medicinal products…

Key legal info on preclinical and clinical trial requirements in Thailand. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for GBP 75.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, the clinical trial does not need to be conducted locally in order to obtain marketing approval. The Thai FDA only requests…

Regulatory, pricing and reimbursement overview in Thailand – a comprehensive legal overview. Prepared in association with Tilleke & Gibbins, a leading law firm in Thailand, this is an extract from The Pharma Legal Handbook: Thailand, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? In Thailand, drugs, biologics, and medical devices are regulated by the Thai Food and Drug Administration (Thai FDA), under the…