New Drug Application submissions

Investigational new drug application — submission and review process. 

Center for Drug Evaluation and Research (CDER). Guidance for Industry. Example of an Electronic New Drug Application Submission, Feb. 17,... 

Figure 19.1 Japanese regulatory review process. Flow of new drug application submission, review and approval. PAFSC, Pharmaceutical Affairs and Food Sanitation Council MHLW, Ministry of Health, Labour and Welfare.

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

This guidance document describes how a New Drug Application (NDA) may be sent electronically to the FDA. The guidance defines how the files in the electronic submission should be structured for FDA review. 

Phase Ilia. Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug Application (NDA) or other dossier. These clinical trials are conducted in patient populations for which the medicine is eventually intended. Phase Ilia clinical trials generate additional data... 

Sietsema WK. Preparing the New Drug Application—Managing Submissions Amid Changing Global Requirements, FDA News, Falls Church, VA, 2006. 

Table 9.1 Percentage of new drug applications (NDAs) approved by period of submission ...

Upon completion of clinical trials, the sponsor will collate all the pre-clinical, clinical and other pertinent data (Table 2.13) and submit this to FDA in support of an application to allow the new drug to be placed upon the market. For CDER-related drugs, this submission document is termed a new drug application (NDA). 

Approval date 1 December 1998 Type of submission New drug application... 

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