The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry "Regulatory Information Management System – Cancellation of Health Product Registrations for non-eCTDs." As SAHPRA moves towards full implementation of eCTD Specification v3.1, many applicants have encountered difficulties in transitioning their legacy dossiers. To streamline regulatory processes and ensure database accuracy, SAHPRA is allowing applicants to request the cancellation of non-eCTD dossiers within a limited timeframe.
SAHPRA has adopted the Regulatory Information Management System (RIMS) to modernize the regulatory submission process, replacing traditional paper-based and non-eCTD electronic formats. The eCTD (electronic Common Technical Document) is now the standard format for regulatory submissions, ensuring compliance with global regulatory best practices.
To facilitate this transition, SAHPRA is granting applicants a limited window from 1 April 2025 to 31 May 2025 to voluntarily cancel health product registrations that are not compliant with eCTD submission requirements.
RIMS is an electronic platform that enables pharmaceutical companies to submit, track, and manage regulatory applications digitally. It is part of SAHPRA’s broader digital transformation strategy. NeeS refers to older electronic submission formats that do not comply with eCTD structure. These formats are being phased out by SAHPRA.
SAHPRA has identified numerous registered products that are no longer marketed or have not been updated to comply with eCTD specifications. To facilitate database cleanup, companies can voluntarily request the cancellation of these registrations.
Process for Requesting Cancellation
Identify non-eCTD dossiers that are either obsolete or not in use.
Submit a formal cancellation request via SAHPRA’s RIMS platform within the specified timeframe.
Ensure all associated regulatory obligations (such as batch recalls or supply chain adjustments) are fulfilled.
Receive confirmation from SAHPRA once the cancellation is processed.
This initiative is particularly important for companies that no longer wish to maintain regulatory obligations for certain products or plan to re-submit in eCTD format at a later stage.
For companies that wish to continue marketing their products, SAHPRA recommends migrating existing non-eCTD dossiers into the eCTD format. To do this, applicants must:
Convert non-eCTD files into structured eCTD sequences following SAHPRA guidelines.
Submit the converted dossier via the RIMS system for regulatory review.
Ensure technical validation using SAHPRA’s eCTD checker tools.
Monitor approval status and respond to queries via RIMS.
Companies that fail to transition to eCTD or do not request cancellation within the designated timeframe may face automatic deregistration of non-compliant dossiers.
Pharmaceutical companies that do not take action during the cancellation window risk the forced deregistration of non-compliant products. This may lead to:
Legal implications for continued marketing of unregistered products.
Delays in future applications due to non-compliant records.
Potential financial penalties for non-adherence to regulatory requirements.
To avoid these risks, companies are strongly encouraged to review their product portfolios and take appropriate action before the 31 May 2025 deadline.
Companies are urged to review their product registrations, request voluntary cancellations if needed, and transition to eCTD format for continued compliance. Failure to act before 31 May 2025 may result in automatic deregistration and potential regulatory consequences. By embracing SAHPRA’s eCTD framework, pharmaceutical companies can streamline regulatory interactions, enhance submission quality, and improve market efficiency.
🔗 For full details, visit SAHPRA RIMS Cancellation Notice
Comments