PRELIMINARY RECOMMENDATIONS FOR REGISTRATION OF ADVANCED THERAPY MEDICINAL PRODUCTS: THE CASE OF CELL THERAPY MEDICINAL PRODUCTS IN THAILAND
Keywords:
advanced therapy medical products, cell therapy, drug registrationAbstract
Medical treatment has evolved rapidly and is being increasingly tailored for specific diseases of particular patients, leading to an emergence of Advanced Therapy Medicinal Products (ATMPs). These ATMPs entail cell therapy medicinal products which are derived from both patients themselves and other individuals. Because the products are made specific to each patient, the amount of production is smaller than the production of other medical products. Henceforth, there is a need for regulatory bodies to come up with new regulation for drug registration to be applied to cell therapy medicinal products in Thailand. The objective of this study is to formulate such preliminary recommendations for drug registration. This is qualitative research conducted through semi-structured questionnaire with 19 key informants, purposively selected, which entail members of regulatory bodies dealing with medical products in the government and entrepreneurs, which encompass manufacturers and importers who are licensed with Drug Act B.E. 2510. It is found that cell therapy medicinal products are different from biologic drugs; therefore, regulations should be different in certain dimensions. For example, risk management should be an element of conditional approval of drug registration, since autologous medical products are being produced in limited amount there should be other pathway of examination that do not require the drug samples themselves before authorization for marketing, issuance of Certificate of Lot Release, and retainment of drug samples, and risk-based: SMP level 1 follow-up should be implemented, whereby patients are followed up actively in the first two years and regularly thereafter. Other than that Thai FDA freely able to tailor made following up procedure of patients of cell therapy medicinal products in order to better protect consumers of the products. At the moment, cell therapy medicinal products have not been registered in Thailand. Thus, Thai FDA is the main institution in oversight the health products with supports from the Department of Medical Sciences and they should be equipped with knowledge, laboratory capabilities, and manpower for cell therapy medicinal products to be registered in Thailand.
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