The SAHPRA released a "Communication to Industry on Quality Variations" document that addresses updates on the submission requirements and process improvements for post-registration quality variations in eCTD format for registered vaccines and pharmaceutical products in South Africa. This guidance, effective from 11 November 2024, is intended to standardize the submission of quality variations and clarify the procedures for handling specific types of modifications within the eCTD system.
This guidance informs the industry about general announcements regarding quality variation post-registration and the submission of exception codes. The document contains information that the applicant should consider when submitting applications for review. It includes general information applicable to application submissions and exception codes for variations applicable to South Africa.
The guidance discusses about
Status Updates: For any queries regarding application status, applicants should include a screenshot of the Variations Status Checker Portal to expedite the response process.
Z-code Requests: A Z-code request requires a cover letter with justification (GLF-HPA-06A) and should be directed to a dedicated email, avoiding direct contact with individual staff.
Extension Requests: Extensions of up to 90 days are allowed, with longer extensions requiring further justification.
A list of specific codes and classifications (Type IA, Type IB, Type II) is provided for various quality changes, such as changes to specification parameters, test procedures, and container types.
Key Exception Codes and Descriptions:
B.I.b.1a - B.I.b.1i: Variations related to changes in active substance specifications, allowing the adoption of monographs from recognized pharmacopeias.
B.II.a.1.a, B.II.a.1.b: Changes in imprints, markings, or inks used for product identification.
B.II.d.2.e and f: Changes in test procedures for finished products compliant with recognized standards.
B.r.a, B.r.b, B.r.II: Codes applicable for reliance-based registrations with supporting documents to demonstrate compliance with RRA evaluations.
As of 1 October 2024, SAHPRA requires nitrosamine assessment reports as part of quality variations. Updates in the specifications for nitrosamine impurities in APIs and finished products have designated classifications for efficient review and safety assurance.
This SAHPRA communication provides a comprehensive set of instructions and guidelines to streamline the submission and approval process for quality variations in the eCTD format. For the complete document and details on each procedure, access the full guidance on the SAHPRA website.
Comments