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. 2022 Sep 3;14(9):1860. doi: 10.3390/pharmaceutics14091860

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© 2022 by the authors.

Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).

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The Common Technical Document (Reference: [114]). The eCTD has five modules: 1. Administrative information and prescribing information. This is a country specific regional module, i.e., different for each region or country; 2. Common technical document summaries. This is a common module in all regions; 3. Quality; 4. Nonclinical study reports; 5. Clinical study reports. Image source: https://www.ich.org/page/ctd © International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, https://www.ich.org/page/legal-mentions (accessed on 1 August 2022).