NAFDAC commenced the electronic submission of Common Technical Documents (CTD) for drug registration in January 2020 and has transited from physical submission of bulk documents known as dossier to submission in an electronic format using pen drives or Compact Disks to submission using cloud based storage such as Dropbox.
The increasing volume of applications received by NAFDAC coupled with dossier review administration issues, resource constraints, and outdated manual document management systems resulted in the development of a significant backlog in medicine registration and prolonged review timelines.
NAFDAC management has been working to increase resources and improve its processes by injecting quality into its regulatory review process and along with other initiatives and interventions.
One of such initiatives is the development of a state of Art solution called Dossier Review Management System (DRMS) to drive the quality, consistent and reliable regulatory review process in compliance with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) requirements.
Dossier Review Management System Processes
Registration: The applicant initiates the process by registering their profile on the the platform which would be verified before the user could be able to upload the electronic dossier into the system.
Submission: Follow ICH CTD folder structure and upon the successful submission, the dossier is evaluated in two steps:
Screening: checked for completeness (are all relevant documents uploaded, including manufacturer information?}. If a submission fails at the screening stage, the applicant will receive a feedback specifying the reason for the failure.
Review: Dossiers that scale through the screening stage are assessed for safety, efficacy and quality; any submission that scales through the review process is presented for approval at the monthly products approval meetings after all other requirements has been met.
Tracking: Applicant will now have access to track real time progress of status of Dossiers as it moves through the backoffice stages within NAFDAC.
Payment: Dossier owners will be able to pay the Dossier Review fees on the platform
Benefits of the Dossier Management system:
State-of-the-Art platform that automates/digitizes all the tasks in the Dossier Management division with central dashboard
User Friendly and provide end-to-end paperless processing
Provide an easy to follow CTD folder structure standard (Bookmarking and Structured file upload)
Facilitate online submission and tracking of applications.
Streamline the regulatory review process allowing for simultaneous Reviewer processes
Enhanced stakeholders relationship through improved communication and transparency
Ensure consistent defensible, and predictable decision making
Performance monitoring features for dossiers and users
Notification when dossier window is opened
Track-able Feedback to Dossier owner on the platform dashboard
Reduce administrative workload by 35% internally.
In Conclusion, Dossier Review management System provide an opportunity for the regulators to use modern Information Technology based tools for making Dossier review process more efficient in a way to ensure quality, efficacious and safe medicinal products are made available and accessible in a timely manner to the general public.
This is the first phase of the digital transformation of the entire drug registration process. Site inspection and Integration with the Laboratory will be managed online soon.