2 min read
The World Health Organization (WHO) Prequalification program plays a vital role in ensuring access to safe and effective medical products. Traditionally, submissions for prequalification may have been filed in a non-eCTD format. However, the WHO is transitioning towards eCTD submissions for both new and existing products.
This blog post dives into the process of converting a non-eCTD submission to an eCTD format for prequalified products, helping you navigate this crucial step.
Why eCTD?
Imagine a world where your submissions are not only uniform and structured but also easy to manage and access. That's the world eCTD opens up for you. Here’s why this transformation is a game-changer:
- Standardization: Say goodbye to the chaos of inconsistent submissions. With eCTD, everything follows a uniform structure.
- Efficiency: Manage large volumes of data without breaking a sweat.
- Accessibility: Regulators can easily access and review documents, speeding up the approval process.
- Compliance: Stay ahead of the curve with enhanced adherence to regulatory requirements.
Ready, Set, Convert! The Step-by-Step Guide
- Assessment and Planning
- Evaluate Existing Submissions: Dive deep into your current non-eCTD submissions to pinpoint what’s needed for conversion.
- Craft a Conversion Plan: Map out a clear, detailed plan outlining each step, timeline, resources, and team responsibilities.
- Document Preparation
- Reorganize Content: Restructure your existing documents to fit the eCTD modules and sections.
- Ensure Completeness: Double-check that all necessary documents and data are ready to go.
- Technical Conversion
- Choose Your eCTD Software: Pick reliable, regulatory-compliant eCTD submission software.
- Format Documents: Convert your documents to the required formats (think PDF, XML) while ensuring they meet eCTD specifications.
- Compile eCTD Sequence: Piece together the documents into a seamless eCTD sequence, following the eCTD structure.
- Quality Control
- Validate Your Submission: Use validation tools to ensure technical accuracy, completeness, and regulatory compliance.
- Conduct an Internal Review: Meticulously review the converted eCTD submission to ensure it meets all standards.
- Submission and Follow-Up
- Submit to WHO: Upload your eCTD sequence to the WHO Prequalification program via the designated submission portal.
- Monitor Feedback: Keep an eye on feedback or queries from WHO and respond promptly.
Pro Tips for a Smooth Conversion
- Invest in Training: Equip your team with the knowledge and skills needed to handle eCTD requirements and software.
- Stay Updated: Keep abreast of the latest WHO guidelines and eCTD regulatory requirements.
- Collaborate with Experts: Engage with regulatory experts and consultants to tackle any conversion challenges head-on.
Your Next Step Towards Excellence
Converting non-eCTD to eCTD submissions for WHO Prequalified products isn’t just a task—it’s a leap toward innovation and efficiency. By embracing this structured approach and utilizing the right tools, you ensure a smooth transition that supports global health efforts by making safe and effective medical products more accessible. A seasoned regulatory partner like Freyr can assist in ensuring compliance with the latest regulations is crucial for a successful eCTD dossier submission.
