The World Health Organization (WHO) will streamline medicine prequalification with the launch of an electronic prequalification portal called ePQ System (ePQS) portal to manufacturers and external users on January 1, 2024.
This digital innovation is expected to provide unprecedented transparency, efficiency, and accessibility in medicine, diagnostics, and vaccines, said WHO in a press release.
The ePQS portal is the culmination of a multi-year effort to revolutionize how WHO manages prequalification information for a diverse range of products, including medicines, diagnostics, vector control products, vaccines, immunization devices, and quality control laboratories. Its innovative features promise to bring unparalleled advantages to manufacturers, national regulatory agencies, and other stakeholders in the healthcare ecosystem.
Streamlining the Prequalification Process
One of the key challenges that the ePQS portal aims to address is the cumbersome manual processing of over one thousand applications received by WHO in 2022. These applications required extensive manual work by WHO's Prequalification Team (PQT) staff. With the ePQS portal, this process will be significantly accelerated, reducing the burden on staff while enhancing transparency and usability.
Technical Advancements of ePQS
The ePQS portal centralizes WHO's Prequalification Unit's core functions into one cohesive platform. The system comprises four integrated components:
Core Salesforce-based Database: This is the backbone of the portal, used internally by the PQ team to manage product information, applications, inspections, and other essential records.
Integrated Document Management System (DMS): The DMS efficiently handles internally generated and submitted information, correspondence, and documents associated with prequalification activities.
Specialized Document Repository: This repository is tailored to receive and manage product dossiers in electronic Common Technical Document format, a critical format for various pharmaceutical areas.
Community Salesforce Portal: External users, such as manufacturers and national regulatory agencies, can access, manage, and monitor their products, procedures, correspondence, and inspections through this portal.
Enhancing Efficiency and Transparency
ePQS will provide real-time access to application status and information. For applicants, it streamlines the process of creating and submitting applications and documents, tracking application progress, and responding to requests for information.
National Regulatory Agencies involved in WHO's Collaborative Registration Processes will also find a valuable resource in the portal, providing a centralized location for accessing relevant information and documents.
Integration of electronic Common Technical Document (eCTD) submissions allows for a more efficient assessment review process. Manufacturers can benefit from easier navigation, identification of document changes, and simultaneous remote review by multiple assessors.
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