Final answer:
Marketing applications for pharmaceuticals in the US, EU, or Japan use the Common Technical Document format, which harmonizes submission processes across different regulatory jurisdictions. For FDA approval, researchers submit an IND and, if successful after clinical trials, a New Drug Application.
Step-by-step explanation:
Data and information submitted as part of marketing applications for a pharmaceutical for human use in the US, EU, or Japan follow the Common Technical Document (CTD) format. This harmonized submission format is part of the concerted effort under the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The CTD format streamlines the process and makes it easier for companies to prepare applications that can be submitted to regulatory authorities in different jurisdictions. It contains sections for administrative information, summaries of modules, quality data, nonclinical study reports, and clinical study reports.
To gain FDA approval for a new therapy, significant data from laboratory and animal trials are collected and an Investigational New Drug (IND) application is submitted to the FDA's Center for Drug Evaluation and Research (CDER). After a 30-day review period, and assuming no clinical hold is issued, clinical trials on humans can begin. The process includes collecting and analyzing data on the therapy’s safety and effectiveness, and if standards are met, an application detailing manufacturing, packaging, and administration procedures is submitted. This is known as a New Drug Application (NDA).