Preliminary Recommendations for Regulation on Service Provision on Advanced Therapy Medicinal Products: Cell-based Therapy in Health Institutions in Thailand

Abstract

Objective: To formulate preliminary recommendations for regulation on service provision of care using advanced therapy medicinal products (ATMPs) in the case of cell-based therapy in health institutions within Thailand. Methods: The research was a qualitative study conducted during March to September 2021. Three parts of the study included 1. Review of literature and related documents 2. Interviews with 17 key informants using semi-structured questionnaire. Key informants were purposively selected from researchers or physicians conducting the study using ATMPs: cell-based therapy and regulators of these products and 3. The formulation of preliminary recommendations on the regulation of provision of care using ATMPs: cell-based therapy within Thai health institution, and sent the summary of the recommendations to the interviewees for reconsideration. Results: All key informants agreed upon that in order to ensure patient safety using ATMPs: cell-based therapy, specific requirements for this service should be established including those for qualification of physicians providing the service, production site, standard of laboratory and health institutions, medical practices, and monitoring of the use of ATMPs: cell-based therapy. Conclusion: The regulation for providing services using ATMPs: cell-based therapy in health institutions require collaboration from various organizations, such as Department of Health Service Support, Thai Food and Drug Administration, Department of Medical Sciences, The Medical Council and relevant Royal Colleges in order to ensure patient access and safety.