DEVELOPMENT OF A REGULATORY GUIDELINEFOR CELL THERAPY MEDICINAL PRODUCTS IN THAILAND

Abstract

Treatment approaches have evolved rapidly and are being increasingly customized to specific diseases or particular patients, leading to the emergence of Advanced Therapy Medicinal Products (ATMPs). These ATMPs entail cell therapy medicinal products. These are emergence of new products. The objective of the research was to develop guidelines for the regulation of cell therapy medicinal products in Thailand, both in terms of use within medical institutions and drug registration. The research was a qualitative study conducted from March to September 2021. Three parts of the study included 1. Review of literature and related documents 2. Interviews with 34 key informants using a semi-structured questionnaire. Key informants were purposively selected from researchers or physicians conducting the study using cell-based therapy and regulators of these products and manufacturers and importers who are licensed with the Drug Act B.E. 2510 (1967). 3. Formulation of the guideline of cell therapy medicinal products to verify from all stakeholders, both in terms of use within medical institutions and drug registration, as well as sent the summary of the recommendations to the interviewees for reconsideration. The results found that: 1. To ensure patient safety using cell-based therapy within medical institutions, specific requirements for this service should be established including those for qualification of physicians providing the service, manufacturing site, standard of laboratory, medical institutions, medical practices, cell therapy medicinal products, and monitoring of the use of cell-based therapy 2. ATMPs: cell therapy medicinal products are different from other chemical or traditional biological drugs. Therefore, different regulations are developed, including the need to submit conditional approval with a Risk Management Plan, consideration without samples for testing before marketing authorization, certification of lot release, and retain samples. In particular, the autologous product is limited quantities and specific patients. Moreover, risk-based: SMP level 1 follow-up is applied. The extensive safety and efficacy post-marketing process should be carried out for two years, following which it should be maintained until lifelong. Additionally, Thai Food and Drug Administration (FDA) freely able to tailor-made following up procedure of patients in order to better protect patients. The regulation for providing services using ATMPs: cell therapy medicinal products in Thailand require collaboration from various organizations, such as the Department of Health Service Support, Thai FDA, Department of Medical Sciences, The Medical Council, and relevant Royal Colleges to ensure patient access and safety. However, cost-effectiveness evaluation to care for patients who untreatable previously standard therapy is ultimately recommendations for further research studies.

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