US & EU GUIDANCE
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2026
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| author | Ranjitha, Nallagandla Ugandar, Dr. R. E. Venkatagir, Kiranmai Ambati, Sandeep Reddy Raviteja, Nimmala |
| author_facet | Ranjitha, Nallagandla Ugandar, Dr. R. E. Venkatagir, Kiranmai Ambati, Sandeep Reddy Raviteja, Nimmala |
| contents | <p><span>The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are responsible for the regulations regarding clinical research in the US and the EU, respectively. This chapter reviews, compares and contrasts the regulations relevant for clinical research in both jurisdictions. To begin, it will review the configuration of the U.S. system with a focus on the centrally important investigational new drug (IND) application coded as Title 21 of the Code of Federal Regulations (CFR) to highlight this framework. The FDA's centralized oversight of clinical trials depends on the IND process (21 CFR Part 312), concurrent review by an Institutional Review Board (IRB) (21 CFR Part 56), along with requirements for the protection of human subjects (21 CFR Part 50). The coordinated strategy of the EU's Clinical Trials Regulation (CTR) 536/2014 to support multi-national trials using a single submission system known as the Clinical Trials Information System (CTIS) will then be discussed. A key focus of the chapter is the EU's two-part Clinical Trial Application (CTA) dossier, which highlights the joint scientific assessment process (Part I) to provide approval for the trial at a central or EU level versus the ethical and local process that lies at each nation's local level, described in Part II of the CTA. The differences and similarities that are given in this chapter include the process of submitting, the schedule of reviews, risk management, and development requirements within the pediatric field. Therefore, the chapter is indicative of differences and substantial changes and generalizations to each area of practice.</span></p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_18444013 |
| institution | Zenodo |
| language | |
| publishDate | 2026 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | US & EU GUIDANCE Ranjitha, Nallagandla Ugandar, Dr. R. E. Venkatagir, Kiranmai Ambati, Sandeep Reddy Raviteja, Nimmala FDA EMA Clinical Trial Regulation IND Application Regulatory Harmonization <p><span>The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are responsible for the regulations regarding clinical research in the US and the EU, respectively. This chapter reviews, compares and contrasts the regulations relevant for clinical research in both jurisdictions. To begin, it will review the configuration of the U.S. system with a focus on the centrally important investigational new drug (IND) application coded as Title 21 of the Code of Federal Regulations (CFR) to highlight this framework. The FDA's centralized oversight of clinical trials depends on the IND process (21 CFR Part 312), concurrent review by an Institutional Review Board (IRB) (21 CFR Part 56), along with requirements for the protection of human subjects (21 CFR Part 50). The coordinated strategy of the EU's Clinical Trials Regulation (CTR) 536/2014 to support multi-national trials using a single submission system known as the Clinical Trials Information System (CTIS) will then be discussed. A key focus of the chapter is the EU's two-part Clinical Trial Application (CTA) dossier, which highlights the joint scientific assessment process (Part I) to provide approval for the trial at a central or EU level versus the ethical and local process that lies at each nation's local level, described in Part II of the CTA. The differences and similarities that are given in this chapter include the process of submitting, the schedule of reviews, risk management, and development requirements within the pediatric field. Therefore, the chapter is indicative of differences and substantial changes and generalizations to each area of practice.</span></p> |
| title | US & EU GUIDANCE |
| topic | FDA EMA Clinical Trial Regulation IND Application Regulatory Harmonization |
| url | https://doi.org/10.5281/zenodo.18444013 |