A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for:
- or in response to a request for additional information
What are the types of formats of regulatory submissions?
- Paper submissions
- Non-eCTD electronic submissions (NEES)
- Electronic submissions with eCTD
Types of regulatory submissions
- Clinical trial applications
- Requests for protocol assistance
- Post-approval studies or commitments
- Requests for orphan drug or fast-track designations
- Licensing applications for drugs, biologics and devices
- Responses to agency questions that arise during review
- Amendment/variation applications or notification submissions
What is the CTD?
The Common Technical Document (CTD) is an internationally agreed format for the preparation of applications for the registration of new medicines. These drugs are designed to be used across Europe, Japan and the United States and must be submitted to the regional regulatory authorities.