Abstract

CROSS-REGIONAL EVALUATION OF IND AND CTA FILING REQUIREMENTS IN THE US AND EUROPE

Katakam Hepsiba*, G. Ramakrishna, M. V. Nagabhushanam, M. Beena Devi,
M. Krishna Snigdha, Enapagundla Brahmareddy

ABSTRACT

Global pharmaceutical development increasingly requires clinical trials to be conducted across multiple regulatory jurisdictions. The United States (US) and European Union/European Economic Area (EU/EEA) represent two major regulatory environments for investigational medicinal products. In the US, clinical development is generally initiated under an Investigational New Drug (IND) application submitted to the US Food and Drug Administration (FDA) under 21 CFR Part 312. In the EU/EEA, clinical trials are authorized through a Clinical Trial Application (CTA) governed by Regulation (EU) No 536/2014 and submitted through the Clinical Trials Information System (CTIS). Although both frameworks share common objectives of participant protection, product quality, scientific validity, and reliable clinical data, important differences exist in regulatory structure, application format, chemistry, manufacturing and controls (CMC), Investigational Medicinal Product Dossier (IMPD) requirements, ethical review, manufacturing authorization, safety reporting, amendments, transparency, and lifecycle management. International Council for Harmonisation (ICH) guidelines have promoted scientific convergence, yet considerable procedural differences remain. This review compares IND and CTA filing requirements, identifies areas of convergence and divergence, and discusses practical strategies for sponsors conducting multinational clinical development. A harmonized global core dossier supported by region-specific regulatory modules is proposed as an efficient approach to simultaneous US and European development.

Keywords: Investigational New Drug, IND, Clinical Trial Application, CTA, FDA, EMA, CTIS, IMPD, clinical trials, regulatory affairs, ICH.