In the ever-evolving landscape of pharmaceutical regulations and submissions, keeping pace with the latest standards is crucial. One such standard that has gained prominence in recent years is the electronic Common Technical Document (eCTD) format. Widely adopted by regulatory authorities around the world, eCTD streamlines the submission process, enhances data quality, and promotes global harmonization. Within this framework, the World Health Organization (WHO) stands as a key player, setting guidelines to ensure the safety, efficacy, and quality of medicinal products. Let’s delve into the intricacies of eCTD submission in WHO.
The introduction of eCTD publishing aims to alleviate the burden of document lifecycle management for applicants and Product Quality Teams (PQT), while also enhancing the efficiency of document review by assessors.eCTD-based applications will be submitted through the ePQS portal.For companies seeking guidance on creating an acceptable eCTD dossier, several reference documents are available through the links provided below.Practical guidance on submission procedures can be found on the ePQS webpage, covering various practical aspects of the submission process.
The transition timeline to eCTD
We are currently in Phase 0. It is anticipated that the portal will go live in the second quarter 2024. Further more specific updates will be provided as timelines become clarified
Phase I APIMF/API-PQ Products | FPP Products | FVP Products:
Phase 0 – eCTD submissions are not possible. Companies should take time to familiarize themselves with WHO PQT requirements and prepare legacy dossiers or new product dossiers in this format.
Phase 1- Commencing 2024
Companies may voluntarily submit applications for new products in eCTD format.
Companies may voluntarily submit Post-PQ Change applications to convert existing prequalified Product dossiers to eCTD.
Phase 2 (+ 1 year) – Commencing 2025
Companies must submit applications for new products in eCTD format. Companies should submit Post-PQ Change applications to convert existing prequalified Product dossiers to eCTD.
In addition, the FPP Requalification procedure will now be used as an opportunity to request a conversion of prequalified Product dossiers to eCTD.
Phase 3 (+ 2 years) – Commencing 2026
Both new and legacy product dossiers must be in eCTD format for APIMFs, API-PQs and FVPs. Companies must submit applications for new FPP products in eCTD format. The FPP Requalification procedure will continue to be used to convert any remaining legacy Product dossiers to eCTD.
For more Update do Visit : https://extranet.who.int/prequal/ectd-portal#:~:text=eCTD%20submissions%20are%20not%20possible,product%20dossiers%20in%20this%
20format.&text=Companies%20may%20voluntarily%20submit%20applications%20for%20new
%20products%20in%20eCTD%20format.
Conclusion:
In an increasingly interconnected world, eCTD submission has emerged as a cornerstone of efficient and harmonized regulatory processes. For pharmaceutical companies seeking approval from WHO, mastering the intricacies of eCTD submission is essential to navigate the regulatory landscape successfully. By embracing eCTD and adhering to WHO’s guidelines, companies can streamline their regulatory activities, enhance data quality, and ultimately bring safe and effective medicines to patients worldwide.
