11 Aug SAHPRA BACKLOG CLEARANCE PROGRAMME NEWSLETTER

The Backlog Clearance Programme has received applications for Re-submission Windows 1 to 9. The quality of submissions has improved significantly. We are receiving all applications submitted on the Document Uploading System via the FTP site and all queries from applicants regarding the FTP site are being handled and addressed accordingly by our Backlog Mailbox and our IT department. We would like to extend our gratitude for your co-operation thus far. A total of 267 new registration applications have been approved by the Programme to date.

While the quality of submissions has improved significantly in the recent past, we are still facing a few challenges and would urge Industry to assist with the following:

• There is a significant number of applicants who do not include the required batch manufacturing records, and this is often identified at technical screening where it contributes to significant delays with the processing of applications.
• Non-compliance with guidelines is also a challenge, and applicants are reminded to strictly adhere to eCTD and eSubmission guidelines and any applicable policies and regulations, as this will help limit back-and-forth interactions between the applicant and SAHPRA. This will culminate in the reduction of the time to process an application.
• We have also noted that applicants do not include the hyperlinks specified in relevant guidelines.
• Furthermore, some of the applications for Reliance review are of poor quality or incomplete and miss supporting documents, such as unredacted reports and the closed part of the DMF. This delays the review of these applications as the onus then falls on SAHPRA to source these documents on behalf of the applicant.

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