This notice provides an update regarding the continuation of the Type II Variations Pilot Submission Windows and introduces specific process enhancements....
The South African Health Products Regulatory Authority (SAHPRA) has released the updated eCTD defined lists and document matrices, effective 10 October 2026. The update includes 31 new submission types (sub-type-51 to sub-type-81) and new entries in the application type, sequence type, submission lead and evaluation...
The Authority has received requests from applicants for additional time to complete the Medicines Registry linkage and IDMP data requirements that were communicated following the Engagement Portal webinar of 26 August 2026. This notice shall be read in conjunction with Communication Issue No.: HPA18-2026/27...
The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants and holders of certificates of registration that the submission window for Type II Variations Pilot Project, including related changes bundled variations submissions, has been extended to Friday, 30 October 2026....
Following the Engagement Portal webinar of 26 August 2026, this communication sets out the key activities and dates for the two programmes that sit with Health Products Authorisation (HPA) and confirms the requirements for their completion....
The South African Health Products Regulatory Authority (SAHPRA) calls on industry stakeholders to verify their records and identify any variation applications that may have been submitted but remain unprocessed due to the transition to the new system. The applications that may have been affected were...
As part of implementing the Traceability Guideline on Health Products, the South African Health Products Regulatory Authority (SAHPRA)continues to engage with industry stakeholders, sector associations, and public-sector partners as the project moves from planning phase to delivery. An important part of this work is the survey...
The South African Health Products Regulatory Authority (SAHPRA) hereby notifies all applicants and holders of certificates of registration that the submission window for Type II Variations Pilot Project , including related changes bundled variations submissions, has been extended to Friday, 31 July 2026....
New cover letter template for post-reg variations...
The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants that Type II Variations Pilot submission window has been extended from 21 April 2026 to 30 April 2026....