Regulatory System for Advanced Therapy Medicinal Products and Recommendations for Thailand
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Abstract
At present, treatment with pharmaceutical products has been advanced by applying scientific, biologic and technological knowledge to create innovative treatments such as products related to stem cell, cell therapy, gene therapy and tissue engineering. These products are called advance therapy medicinal products (ATMPs) for the treatment of diseases that cannot be cured in the past, especially those with pathology specific to cells or genes. Literature review found that a number of studies for cells, genes and tissue engineering products is increasing every year. However, there were a few ATMPs available on market, possibly due to the complexity of the manufacturing process, long duration of research studies, high costs of products, limited number of patients participating in the study, and regulation on product approval. However, at present, cells, genes and tissue engineering products are successfully developed from laboratory into ATMPs. Most of the products were from EU, USA and Japan. In Thailand, there were studies and application of ATMPs for patient treatment, but it could not produce ATMPs. Therefore, it is important and necessary for Thailand to study the guidelines and regulatory measures of ATMPs from those three countries in order to apply the measures in Thailand and setting up relevant system from initial product development to finished products for protecting safety of patients from ATMPs in the future
Article Details
ผลการวิจัยและความคิดเห็นที่ปรากฏในบทความถือเป็นความคิดเห็นและอยู่ในความรับผิดชอบของผู้นิพนธ์ มิใช่ความเห็นหรือความรับผิดชอบของกองบรรณาธิการ หรือคณะเภสัชศาสตร์ มหาวิทยาลัยสงขลานครินทร์ ทั้งนี้ไม่รวมความผิดพลาดอันเกิดจากการพิมพ์ บทความที่ได้รับการเผยแพร่โดยวารสารเภสัชกรรมไทยถือเป็นสิทธิ์ของวารสารฯ
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