แนวทางการควบคุม กำกับดูแลผลิตภัณฑ์นาโนของสำนักงานคณะกรรมการอาหารและยา ณ ปัจจุบัน Current Regulation on Nanoproducts of Thai Food and Drug Administration

Abstract

Nanotechnology has been increasingly applied to several products inThailand. In addition to control and regulation on health products, Thai FDAunder the Ministry of Public Health also promotes research activities andthe development of knowledge, technology, and consumer protection’ssystems to ensure the efficacy and effectiveness of health products. Thisarticle therefore aims to gather information concerning Thai FDA guidelineson regulating nanoproducts classified into five product groups (food,medicines, medical devices, cosmetics and hazardous substances). Theinformation provided in this article would be helpful for the improvement ofregulation guidelines of Thailand’s nano products in the future. Thisinformation shows that the Thai FDA has no specific regulations ofnanoproducts in all five product groups. However, the Thai FDA certainlyrealizes the significance of nanotechnology. Thus, it has established aworking group for development and establishment of guidelines onregulating the effectiveness and safety of nanoproducts. According to theNational Nanotechnology Strategic Plan (2007-2013), 3 work plans havebeen developed by the working group. These work plans include 1) thedevelopment and revision of regulatory measures for nanoproducts underthe supervision of the Thai FDA 2) the establishment of regulatorymeasures and guidelines for health products’ advertisement and 3) thereinforcement of knowledge of FDA staff, entrepreneurs, and consumers.The working group has been carrying out activities under the 3 work plans.Keywords: nanotechnology, nanomaterial, regulation of nanotechnology