Examination of the Regulatory Frameworks Applicable to Biologic Drugs (Including Stem Cells and Their Progeny) in Europe, the US, and Australia: Part II-A Method of Software Documentary Analysis
Apstrakt
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. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the... previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920
Ključne reči:
Cellular therapy / Clinical translation / Clinical trials / EthicsIzvor:
Stress-The International Journal on the Biology of Stress, 2012, 1, 12, 909-920Izdavač:
- Wiley, Hoboken
DOI: 10.5966/sctm.2012-0038
ISSN: 2157-6564
PubMed: 23283552
WoS: 000312823200006
Scopus: 2-s2.0-84872946357
Institucija/grupa
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/123456789/1690 AB - 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. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920 PB - Wiley, Hoboken 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 II-A Method of Software Documentary Analysis VL - 1 IS - 12 SP - 909 EP - 920 DO - 10.5966/sctm.2012-0038 ER -
@article{ author = "Ilić, Nina and Savić, Snežana and Siegel, Evan and Atkinson, Kerry and Tasić, Ljiljana", year = "2012", abstract = "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. Eighteen high-tier documents from the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) regulatory frameworks were subject to automated text analysis. Selected documents were consistent with the legal requirements for manufacturing and use of biologic drugs in humans and fall into six different categories. Concepts, themes, and their co-occurrence were identified and compared. The most frequent concepts in TGA, FDA, and EMA frameworks were "biological," "product," and "medicinal," respectively. This was consistent with the previous manual terminology search. Good Manufacturing Practice documents, across frameworks, identified "quality" and "appropriate" as main concepts, whereas in Good Clinical Practice (GCP) documents it was "clinical," followed by "trial," "subjects," "sponsor," and "data." GCP documents displayed considerably higher concordance between different regulatory frameworks, as demonstrated by a smaller number of concepts, similar size, and similar distance between them. Although high-tier documents often use different terminology, they share concepts and themes. This paper may be a modest contribution to the recognition of similarities and differences between analyzed regulatory documents. It may also fill the literature gap and provide some foundation for future comparative research of biologic drug regulations on a global level. STEM CELLS TRANSLATIONAL MEDICINE 2012;1:909-920", publisher = "Wiley, Hoboken", 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 II-A Method of Software Documentary Analysis", volume = "1", number = "12", pages = "909-920", doi = "10.5966/sctm.2012-0038" }
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 II-A Method of Software Documentary Analysis. in Stress-The International Journal on the Biology of Stress Wiley, Hoboken., 1(12), 909-920. https://doi.org/10.5966/sctm.2012-0038
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 II-A Method of Software Documentary Analysis. in Stress-The International Journal on the Biology of Stress. 2012;1(12):909-920. doi:10.5966/sctm.2012-0038 .
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 II-A Method of Software Documentary Analysis" in Stress-The International Journal on the Biology of Stress, 1, no. 12 (2012):909-920, https://doi.org/10.5966/sctm.2012-0038 . .