Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part I-A Method of Manual Documentary Analysis
Abstract
Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual ...documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:898-908
Keywords:
Cellular therapy / Clinical translation / Clinical trials / EthicsSource:
Stress-The International Journal on the Biology of Stress, 2012, 1, 12, 898-908Publisher:
- Alphamed Press, Durham
DOI: 10.5966/sctm.2012-0037
ISSN: 2157-6564
PubMed: 23283551
WoS: 000312823200005
Scopus: 2-s2.0-84872922024
Collections
Institution/Community
PharmacyTY - JOUR AU - Ilić, Nina AU - Savić, Snežana AU - Siegel, Evan AU - Atkinson, Kerry AU - Tasić, Ljiljana PY - 2012 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1689 AB - Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:898-908 PB - Alphamed Press, Durham T2 - Stress-The International Journal on the Biology of Stress T1 - Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part I-A Method of Manual Documentary Analysis VL - 1 IS - 12 SP - 898 EP - 908 DO - 10.5966/sctm.2012-0037 ER -
@article{ author = "Ilić, Nina and Savić, Snežana and Siegel, Evan and Atkinson, Kerry and Tasić, Ljiljana", year = "2012", abstract = "Recent development of a wide range of regulatory standards applicable to production and use of tissues, cells, and other biologics (or biologicals), as advanced therapies, indicates considerable interest in the regulation of these products. The objective of this study was to analyze and compare high-tier documents within the Australian, European, and U.S. biologic drug regulatory environments using qualitative methodology. Cohort 1 of the selected 18 high-tier regulatory documents from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the Therapeutic Goods Administration (TGA) regulatory frameworks were subject to a manual documentary analysis. These documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Manual analysis included a terminology search. The occurrence, frequency, and interchangeable use of different terms and phrases were recorded in the manual documentary analysis. Despite obvious differences, manual documentary analysis revealed certain consistency in use of terminology across analyzed frameworks. Phrase search frequencies have shown less uniformity than the search of terms. Overall, the EMA framework's documents referred to "medicinal products" and "marketing authorization(s)," the FDA documents discussed "drug(s)" or "biologic(s)," and the TGA documents referred to "biological(s)." Although high-tier documents often use different terminology they share concepts and themes. Documents originating from the same source have more conjunction in their terminology although they belong to different frameworks (i.e., Good Clinical Practice requirements based on the Declaration of Helsinki, 1964). Automated (software-based) documentary analysis should be obtained for the conceptual and relational analysis. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:898-908", publisher = "Alphamed Press, Durham", journal = "Stress-The International Journal on the Biology of Stress", title = "Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part I-A Method of Manual Documentary Analysis", volume = "1", number = "12", pages = "898-908", doi = "10.5966/sctm.2012-0037" }
Ilić, N., Savić, S., Siegel, E., Atkinson, K.,& Tasić, L.. (2012). Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part I-A Method of Manual Documentary Analysis. in Stress-The International Journal on the Biology of Stress Alphamed Press, Durham., 1(12), 898-908. https://doi.org/10.5966/sctm.2012-0037
Ilić N, Savić S, Siegel E, Atkinson K, Tasić L. Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part I-A Method of Manual Documentary Analysis. in Stress-The International Journal on the Biology of Stress. 2012;1(12):898-908. doi:10.5966/sctm.2012-0037 .
Ilić, Nina, Savić, Snežana, Siegel, Evan, Atkinson, Kerry, Tasić, Ljiljana, "Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part I-A Method of Manual Documentary Analysis" in Stress-The International Journal on the Biology of Stress, 1, no. 12 (2012):898-908, https://doi.org/10.5966/sctm.2012-0037 . .