The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of registered human and veterinary medicines. The renewal process ensures that registered medicinal products continue to meet safety, efficacy, and quality standards.
The latest February 2025 update clarifies the renewal process, application requirements, legal provisions, and technical aspects involved in renewing a medicine’s certificate of registration.
A renewal of registration is the process by which a registered medicinal product is reassessed to confirm its continued compliance with Good Manufacturing Practice (GMP) and the latest scientific requirements.
Why is renewal necessary?
Ensures continued safety, quality, and efficacy of medicines.
Updates dossiers with regulatory changes and post-registration variations.
Prevents registration cancellation due to non-compliance.
Download: SAHPRA Renewal Process Flow
The renewal process is governed by the Medicines and Related Substances Act, 101 of 1965, as amended.
Key Legal Provisions:
Section 2B(1)(c): Requires periodic re-evaluation of registered medicines.
Section 15(6)(a)(b): Limits medicine registration to five years, requiring renewal.
General Requirements for Renewal Applications
Submission Timeline: Applications must be submitted six months before the expiry of registration.
Format: Applications must follow the Electronic Common Technical Document (eCTD) format.
Supporting Documents:
Application letter (Module 1.0.1).
Proof of payment for the renewal fee.
Product Quality Review (PQR) for the last five years.
Risk Management Plan (RMP) and Pharmacovigilance data.
GMP compliance certificates for manufacturing sites.
Updated Product Information (PI) and Patient Information Leaflet (PIL).
Application Process for Renewals
Step 1: Screening of Application
SAHPRA checks for completeness and validity of the application.
One round of screening queries is allowed, with a 10-day response time.
Step 2: Evaluation of the Renewal Application
SAHPRA reviews safety, efficacy, and quality data.
Queries may be issued, with two rounds of queries allowed.
Applicants have 30 days to respond to each query.
Step 3: Decision on Renewal
If approved, a renewed certificate of registration is issued.
If rejected or withdrawn, the medicine’s status changes to "Cancelled" in SAHPRA’s register.
Post-registration variations (changes to formulation, manufacturing site, or labeling) must be submitted separately from the renewal. Any pending Transfer of Applicant (ToA) changes must be completed before submitting a renewal request.
SAHPRA Renewal Review Timeline
Total review time: 6 months (120 working days).
10 days for screening responses.
30 days per evaluation query round (maximum of 2 rounds).
Failure to renew leads to automatic registration cancellation.
If a renewal query requires additional variations, applicants must submit a separate variation request.
SAHPRA’s updated renewal process aligns with global regulatory standards, ensuring that medicines remain safe, effective, and high quality.
📌 For full details, refer to the official SAHPRA guideline:🔗 SAHPRA Renewal Process
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