Regulatory Frameworks for Advanced Therapy Medicinal Products in Thailand.

Advanced Therapy Medicinal Products (ATMPs) are a new class of medicinal products that fall under the Drug Act. B.E.2510. The Medicines Regulation Division, a regulatory unit under the Thai Food and Drug Administration, takes responsibility for the regulation of ATMPs. This includes importing or manufacturing of ATMPs for clinical trials, GMP inspection, and marketing authorization. In Thailand, ATMPs have been classified into four groups: cell therapy medicinal products, gene therapy medicinal products, tissue-engineered products, and combined ATMPs. At present, the guidelines for biological products are applied to ATMP in clinical trials and marketing authorization applications. At the same time, the specific guidelines for ATMPs are under development. This chapter provides an overview of the Thai FDA regulatory oversight of ATMPs, which covers investigational ATMPs, GMP certification, and marketing authorization.

Evolution of Trans-fatty acid consumption in Thailand and strategies for its reduction.

Eliminating industrially produced trans-fatty acids (TFAs) from the food supply is one of the World Health Organization's (WHO's) priority targets to control and prevent non-communicable diseases. This review paper describes the strategies used to reduce TFA consumption in Thailand based on a situation analysis consisting of an assessment of TFA content in the national food supply, its intake, and stakeholder-based analysis of Strengths, Weaknesses, Opportunities, and Threats (SWOT). The analysis resulted in the drafting of a regulatory approach, which was then considered by stakeholders. Bakery products containing partially hydrogenated oils (PHOs) are the major sources of TFAs in Thailand. Palm and coconut oil as well as blending technology are locally available as PHO replacements. Thailand's Food and Drug Administration has taken legal action to prohibit the production, import, and distribution of PHOs and their products. Post-marketing TFA levels are currently being monitored, ie, TFAs in fat/oil and butter must not exceed 2% and 6% of fat content, respectively. For other food categories, TFAs must not exceed 0.5 g per serving unless the TFAs are from ruminant sources. The key factor to successfully reducing TFAs in Thailand is the partnership between public and private sectors, professional associations, and consumers, based on scientific evidence regarding the negative impact of TFA intake on cardiovascular health.