A platform for the processing of Prequalification Information for medicines, diagnostics, vector control products, vaccines, immunization devices, quality control laboratories and inspections has been successfully developed for PQ users with WHO ready to open the ePQ system (ePQS) portal to manufacturers and other external users by 1st of January 2024. The new system will mean that users have oversight of all their products, applications and inspections that the WHO PQ unit works with and importantly, will be able to see where their applications sit within a specific PQ process.
The new system will enable manufacturers, National Regulatory Agencies and other stakeholders to log into the portal, lodge applications for products, upload and download documents and receive notification of pending actions. Ultimately it will help patients, who will benefit from efficiencies this system will create and the improved speed at which a product is reviewed.
In 2022, WHO received over one thousand applications, all of which required manual creation by PQT staff. The new portal will speed that process up whilst adding important usability improvements and transparency.
Technical benefits of ePQS
ePQS is a new IT solution that brings all core areas of work of WHO’s Prequalification Unit into one centralized platform including WHO’s collaborative procedures and complaints testing. In total it will encompass 13 unique product types, 48 unique application types plus many other supporting record types. It consists of four integrated systems:
- The core Salesforce-based database for internal PQ team use, where information regarding products, applications, inspections and a variety of other records are maintained.
- An integrated Document Management System (DMS) to manage internally generated and submitted information, correspondence and other documents associated with prequalification activities.
- A specialized document repository to receive and manage product dossiers in electronic Common Technical Document format used in the areas of Active Pharmaceutical Ingredients, Finished Pharmaceutical Products and Finished Vaccine Products.
- Finally, a community Salesforce Portal where external users can access, manage and monitor their products, procedures, correspondence and inspections.
Process-related milestones are captured in greater detail and harmonization which improves reporting on key performance indicators. The design of ePQS makes it easier to view where records are being used in other procedures, such as in related applications, inspections or as part of a Collaborative Registration Procedure. Plus, for more complex situations, reports can be created to extract and compile this information.
Integration is being rolled out between ePQS and the WHO Prequalification website that will automatically update the lists of Prequalified and Emergency Use Listed products as well as application pipeline pages in real time. Integration of the Salesforce database with the document management system (DMS), allows ready access to relevant documents on a secure platform from any location. The DMS allows the secure sharing of documents internally and externally.
For applicants, the portal provides the ability to securely create and lodge applications and documentation with WHO Prequalification. They can then follow relevant product applications and inspection records immediately, be notified of requests for information, track and respond to these requests and provide and receive documentation. This process improvement will ensure real-time determination of the application status and real time information.
For National Regulatory Agencies, particularly those involved in WHO’s Collaborative Registration Processes, the portal provides a single location where information and documents associated with relevant procedures and products, can be located and accessed.
A final but important aspect of ePQS is an integration that allows applicants to submit electronic Common Technical Document (eCTD) dossiers. eCTD is a well-established international specification for the pharmaceutical industry with regards to the organization and content of pharmaceutical-based applications. It provides significant advantages to manufacturers when compiling and managing the lifecycle of their product-related documentation over time. Additionally, it tracks the history of the individual documents constituting the application dossier, permitting the history of documents within a dossier to be followed by both the applicant and PQT reviewers.
eCTD permits a more efficient assessment review by assessors by enabling faster navigation within and across documents, easy identification of changed documents, easy comparison between document versions and simultaneous review by multiple assessors from remote locations.
Next steps
As the WHO PQ unit works towards the opening of the ePQS Portal, a series of milestones over the next 3 months will be announced. Including:
- The launch of landing pages on the PQ unit website for both the ePQS portal and eCTD Submissions.
- The piloting of the portal with a small number of manufacturers.
- The publishing of increasing amounts of information related to portal functionality and preparation for registration.
- The publishing of WHO PQ eCTD specifications and requirements to permit an applicant to prepare for eCTD submission.
- Webinars for external users to help them understand ePQS better, answer and gather questions.
Once the external user registration process is opened, regular webinars will be held to support new users.
