As the world continues to move towards digitalization, electronic submissions are becoming the norm for Regulatory Bodies across countries. In Europe, the European Union (EU) has established a mandatory electronic Common Technical Document (eCTD) format for the submission of medicinal products’ Regulatory information.
eCTD, a standardized submissions format, was established based on the Regulatory Product Submissions (RPS) standard (HL7 standard) with advice from the ICH. The current eCTD version 3.2.2 will soon be replaced by version 4.0. With various modifications designed to simplify the process for sponsors and Regulatory authorities, eCTD V4.0 has officially been issued. The primary goal is to implement changes that speed up the Regulatory submission process, enhance communication between agencies and sponsors, and improve global harmonization of the format.
eCTD submissions are one of the key steps in the development of pharmaceuticals. What if you miss your product launch due to a delay in eCTD submissions? The cost of lost opportunity per day delay in the product launch is expected to be in the millions. Subsequently, the cost of non-compliance to the Health Authority (HA) timelines and regulations is huge. With the fast-approaching submission deadlines for multiple products in their portfolio, life science companies often struggle to efficiently plan, execute, and track their submission activities.
Regulatory submissions and publishing tasks have traditionally been laborious involving hours of manual efforts for formatting documents, generating agency-compliant PDFs, doing quality checks, assembling documents for submissions, etc. With the demanding timelines, life science companies always rush for timely submissions. Across the globe, Regulatory bodies are gearing up to adopt recent developments like eCTD v4.0 for dossier submissions, amendments, and other reports.
eCTD has turned into a standard norm for industry-wide submissions in a majority of regions across the globe. It provided a single standard for the electronic transmission of submissions data and enabled the industry to communicate and exchange information with Health Authorities harmoniously.
In September 2022, the USFDA released a revised technical conformance guide for electronic Common Technical Document (eCTD) v4.0. The guide provides specifications, recommendations, and general considerations while submitting eCTD-based electronic submissions to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER). The guide also implements the electronic submission requirements of Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).