4 min read
The adoption of electronic Common Technical Document (eCTD) by regulatory authorities continues to reshape the global regulatory landscape. The World Health Organization's (WHO) move toward eCTD for its Prequalification Programme represents another significant milestone in the global transition to standardized digital submissions.
As pharmaceutical companies increasingly pursue global market access, organizations must prepare for evolving submission requirements while ensuring regulatory compliance, technical accuracy, and efficient lifecycle management. , WHO's adoption signals that digital regulatory submissions are becoming an increasingly important expectation across global markets. Harmonizing the documentation across different global markets thus reducing the efforts spend in preparation of country specific dossier.
To better understand what this development means for pharmaceutical companies, we spoke with Gouspasha Mohammed, Senior Manager – MPR Publishing & Submissions at Freyr, who shared his perspectives on the opportunities, challenges, and practical considerations surrounding WHO's adoption of eCTD.
A Conversation with Gouspasha Mohammed
WHO has announced the adoption of eCTD for its Prequalification Programme. Why is this an important milestone for the pharmaceutical industry?
Gouspasha Mohammed: WHO's adoption of eCTD represents much more than the introduction of a new submission format. It reflects the continued global movement toward standardized digital regulatory submissions.
For pharmaceutical companies, this means greater alignment with internationally recognized submission standards while improving the efficiency of dossier management throughout the product lifecycle. Organizations that already have mature eCTD capabilities will likely find it easier to adapt, while others may need to strengthen their publishing and lifecycle management processes.
Ultimately, this transition reinforces the importance of investing in scalable digital submission capabilities that can support multiple regulatory authorities worldwide.
How does WHO's move reflect broader trends in global regulatory submissions?
Gouspasha Mohammed: Over the past decade, we've seen regulatory agencies around the world steadily adopt digital submission standards to improve consistency, transparency, and review efficiency.
WHO's adoption reinforces that trend.
Organizations are increasingly expected to maintain standardized submission structures, consistent document quality, and effective lifecycle management throughout the regulatory process. Digital submissions are no longer viewed as simply a technical requirement—they have become an important part of modern regulatory operations.
As more authorities adopt eCTD, organizations with strong Submission Lifecycle Management capabilities will be better positioned to manage submissions across multiple regions.
Which organizations should pay the closest attention to WHO's eCTD adoption?
Gouspasha Mohammed: Any organization participating in the WHO Prequalification Program should begin evaluating its eCTD readiness.
This includes manufacturers of:
- Generic medicines
- Vaccines
- Biologics
- Active Pharmaceutical Ingredients (APIs)
- Essential medicines intended for global public health programs
Even organizations that already submit eCTD dossiers to other health authorities should assess whether their existing publishing processes align with WHO's specific technical and operational expectations.
Preparing early allows organizations to reduce implementation challenges and strengthen long-term submission readiness.
Beyond creating an eCTD dossier, what operational changes should regulatory teams consider?
Gouspasha Mohammed: Many organizations assume eCTD is simply about publishing documents into the correct electronic format.
In reality, successful implementation begins much earlier.
Regulatory teams should evaluate:
- Submission planning processes
- Document and Data governance
- Lifecycle management procedures
- Publishing quality controls
- Cross-functional collaboration
- Technical validation workflows
A well-organized regulatory operation significantly reduces the likelihood of submission delays and supports efficient lifecycle maintenance after approval.
How important are publishing quality and technical validation in this transition?
Gouspasha Mohammed: They're absolutely essential. Even when scientific content is complete, technical publishing issues can delay submissions or result in validation failures.
Organizations should ensure:
- Accurate XML backbone creation
- Proper hyperlinking and bookmarking
- Correct document granularity
- Technical validation before submission
- Consistent dossier structure
Strong eCTD Publishing practices improve submission quality while helping organizations meet evolving digital submission requirements.
What challenges do organizations commonly encounter during eCTD implementation?
Gouspasha Mohammed: The biggest challenge is often treating eCTD as a one-time publishing activity rather than an ongoing lifecycle process.
Organizations frequently encounter issues related to:
- Inconsistent document management
- Poor version control
- Limited lifecycle planning
- Last-minute publishing activities
- Validation failures
Addressing these challenges requires both technical expertise and well-defined regulatory processes.
How can organizations prepare for the future of digital regulatory submissions?
Gouspasha Mohammed: Preparation starts with evaluating your current publishing capabilities and identifying opportunities to strengthen submission readiness.
Organizations should focus on:
- Standardized publishing workflows
- Robust quality review processes
- Lifecycle management strategies
- Technical validation
- Cross-functional collaboration
- Global submission planning
As additional health authorities continue adopting digital submission standards, organizations with mature publishing operations will be better positioned to respond efficiently.
How is Freyr helping organizations prepare for the growing adoption of eCTD worldwide?
Gouspasha Mohammed: At Freyr, we support organizations throughout the entire publishing and submission lifecycle.
Our teams help clients with:
- eCTD Publishing
- Submission Planning
- eCTD publishing and submission Process setups
- Submission Lifecycle Management
- Technical validation
- Submission quality review
- Lifecycle maintenance
- Global publishing strategy
- Regulatory Project management
Rather than viewing each submission independently, we help organizations establish scalable publishing processes that support long-term regulatory success across multiple global markets.
Any final advice for regulatory teams preparing for this transition?
Gouspasha Mohammed: My advice is simple—don't wait until eCTD becomes mandatory for every market. WHO's adoption is another indicator that standardized digital submissions are becoming the global norm. Organizations that strengthen their publishing capabilities today will be better prepared for future regulatory changes while improving submission quality, operational efficiency, and global filing readiness.
Building strong digital publishing capabilities is no longer just about compliance; it's about creating a sustainable regulatory strategy for the future.
About the Expert
Gouspasha Mohammed is a Senior Manager – MPR Publishing & Submissions at Freyr. He brings extensive experience in regulatory publishing, eCTD submissions, submission lifecycle management, and global regulatory operations. Gouspasha has supported pharmaceutical and biotechnology organizations in preparing compliant electronic submissions for multiple health authorities while helping clients strengthen publishing processes, improve submission readiness, and manage complex regulatory lifecycles across global markets.
To learn more about Freyr's Regulatory Publishing & Submission services, fill out the contact form or write to us at sales@freyrsolutions.com
