South Africs's SAHPRA Communication: Regulatory Information Management System – Application Withdrawal

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry on the process for the withdrawal of registered health products under its Regulatory Information Management System (RIMS) framework. The communication, titled "Application Withdrawal" (HPA15-2025/26), provides step-by-step instructions for applicants navigating the withdrawal process.

This communication applies to the cancellation of health products within Specification 3.1, effective from 1 November 2024. It references the ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information (July 2024, v3.1) and highlights the specific steps involved in lifecycle operations for product withdrawals.

Key Information for Application Withdrawal

Process Overview

The withdrawal of an entire product life cycle involves the following steps:

1. Submission Type: Set the submission type to "Application Withdrawal."

2. Sequence Type: The sequence type should be designated as "Initial."

3. Sequence Description: This should be defined as "Cancellation."

Since the withdrawal is treated as a new submission, the sequence and related sequence should be updated to reflect the next available sequence number.

Documentation Requirements

Applicants must include:

• Letter of Application: A formal letter must be attached to the submission, categorized as "New", explaining the reasons for the withdrawal.

• Baseline Requirements: In cases where no baseline is available in eCTD format, an acceptable baseline must include minimal information, namely:

  • Module 1: Administrative and product details.

  • Module 2: Summaries of Quality, Safety, and Efficacy.

  • Module 3.2.P and Module 3.2.S: Product and substance-related details.

The submission type for the application withdrawal will then follow this baseline data.

Notable Updates in Version 9

The January 2025 update (Version 9) incorporates:

• Clarifications on eCTD Application Withdrawals: Details on sequence description, application types, and handling cases with missing baselines.

• Enhanced Alignment with Specification 3.1: Guidance aligns with SAHPRA's life cycle operations for withdrawals under the eCTD framework.

This communication emphasizes SAHPRA’s commitment to clarity and procedural efficiency for managing product withdrawals under its RIMS framework. By following these detailed instructions, applicants can ensure compliance and maintain transparency in regulatory submissions.

To access the complete information, visit the official SAHPRA website.