Creating A Compliant eCTD: Avoiding Common Regulatory And Technical Pitfalls On The Path To Submission

By Valerie Bright

The Electronic Common Technical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the U.S. Food & Drug Administration (FDA). The eCTD harmonizes the regulatory review process for global drug development, as its structure is based on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

In addition to streamlining the review process for the FDA, the eCTD format also simplifies the submission process for sponsors, as it is the same format used by regulatory agencies in other countries. However, failure to comply with the regulatory and technical requirements could jeopardize the success of your submission and your product development plan as a whole, especially for early-stage biotechs working with limited resources. Here are strategies for avoiding some of the most common electronic publishing pitfalls on the path to submission.