3 Key Differences between Investigational New Drug (IND) Applications and Clinical Trial Applications (CTA) Regulatory Submissions
In the regulatory submission landscape, references to INDs and CTAs are used frequently depending on the type and scope of submission. Below are 3 key differences between these 2 types of submissions.
Country of Submission:
An IND is a regulatory submission that is needed for the initiation of clinical drug trials in the United States.
A CTA is a regulatory submission that is needed for the initiation of clinical drug trials in most of the world including the European Union (EU), United Kingdom (UK), and Canada.
Submission Structure:
An IND is submitted to the Food and Drug Administration (FDA) through an electronic Common Technical Document (eCTD) format, which includes clinical, nonclinical, and Chemistry, Manufacturing, and Controls (CMC) information in forms of different modules and documents.
A CTA is submitted in most parts of the world as an Investigational Medicinal Product Dossier (IMPD), which includes clinical, nonclinical, and CMC information in a single document. The EU requires all information to be submitted to the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS), which allows applications for up to 30 countries with the same documentation.
Additions to Submission once Cleared or Approved
Once submitted for a specific drug and indication, all future studies, documents, and data for that drug and indication are submitted as additions to that same IND.
Depending on country (UK and Canada), CTAs require nonclinical, clinical, and CMC information to be re-submitted each time a new clinical trial is initiated for a specific drug and indication (regardless of previous submission).
Mahin Arastu
Lead Medical Writer