---
title: "NDA — New Drug Application | QbD Group"
description: "The application through which a sponsor asks the FDA to approve a new medicinal product for the United States market. It presents the full development p..."
url: https://qbdgroup.com/en/knowledge-center/glossary/nda
type: "Page"
language: en
publisher: "QbD Group"
citation: "QbD Group, \"NDA — New Drug Application | QbD Group\", https://qbdgroup.com/en/knowledge-center/glossary/nda"
---

[Back to the glossary](https://qbdgroup.com/en/knowledge-center/glossary) Regulatory Glossary

# NDA

New Drug Application

Regulatory Affairs

## Definition

The application through which a sponsor asks the FDA to approve a new medicinal product for the United States market. It presents the full development package: chemistry and manufacturing, non-clinical safety, clinical efficacy and safety, and proposed labelling.

## Related terms

[EU MDRThe European regulation governing the design, manufacture, and placing on the market of medical devices. It replaced the Medical Device Directive and tightened clinical evidence, technical documentation, traceability, and post-market surveillance requirements for all device classes.](https://qbdgroup.com/en/knowledge-center/glossary/eu-mdr)[IVDRThe European regulation for in vitro diagnostic medical devices. It introduced a risk-based classification (A to D), moved most IVDs under notified body oversight, and requires performance evaluation covering scientific validity, analytical performance, and clinical performance.](https://qbdgroup.com/en/knowledge-center/glossary/ivdr)[Notified BodyAn independent organisation designated by an EU member state to assess whether medical devices and IVDs meet regulatory requirements before CE marking. Its conformity assessment covers the quality management system, technical documentation, and ongoing surveillance audits.](https://qbdgroup.com/en/knowledge-center/glossary/notified-body)[CE MarkingThe manufacturer's declaration that a product complies with the applicable EU legislation and may be placed on the European market. For medical devices and IVDs it follows a conformity assessment, usually involving a notified body outside the lowest risk classes.](https://qbdgroup.com/en/knowledge-center/glossary/ce-marking)[MAAThe dossier submitted to EMA or a national authority requesting permission to market a medicinal product in Europe. It compiles quality, non-clinical, and clinical data in the Common Technical Document format, together with labelling and risk management documentation.](https://qbdgroup.com/en/knowledge-center/glossary/maa)[ANDAThe FDA pathway for generic medicines. Instead of repeating clinical efficacy trials, the applicant demonstrates that the generic is pharmaceutically equivalent and bioequivalent to an approved reference product, alongside a full quality and manufacturing dossier.](https://qbdgroup.com/en/knowledge-center/glossary/anda)

## Need more than a definition?

Our regulatory, quality, and clinical specialists turn these requirements into working submissions, systems, and studies.

[Explore our services](https://qbdgroup.com/en/services)[Talk to an expert](https://qbdgroup.com/en/contact)

---

Source: https://qbdgroup.com/en/knowledge-center/glossary/nda — © QbD Group. Quote freely with attribution and a link back.