Regulatory Frameworks for Advanced Therapy Medicinal Products in Thailand.

Abstract

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.