South Africa: Renewal of Medicines Certificate of Registration Framework

On 26th August, 2025 the South African Health Products Regulatory Authority (SAHPRA) has introduced a structured framework for the renewal of certificates of registration for human and veterinary medicines. This initiative aligns with both national legislation and international regulatory standards, ensuring that medicinal products remain safe, effective, and of consistent quality throughout their lifecycle.

Under the Medicines and Related Substances Act (Act 101 of 1965, as amended), medicine registrations are valid for five years. Renewal is therefore critical for:

• Ensuring continued compliance with quality, safety, and efficacy requirements.

• Enabling SAHPRA to periodically reassess medicines, in line with Section 2B(1)(c) of the Act.

• Meeting World Health Organization (WHO) benchmarking standards, which strengthens SAHPRA’s global recognition.

By implementing a structured renewal process, SAHPRA aims to position itself as a trusted regulator in Africa whose decisions can be relied upon by other regulatory authorities worldwide.

SAHPRA’s renewal process is built on comprehensive, stakeholder-informed groundwork, benchmarking against other African and MENA regulators and conducting close consultations with the WHO.

Core components:

• Legal compliance: All renewals are governed by Acts, Regulations, and relevant sections of the Medicines Act.

• Transparent Fees: New fee structures (effective February 2025) are published on the SAHPRA website, based on rigorous cost-to-serve analysis.

• Human Resources and Capacity: Staged implementation and detailed guidance aim to ease the administrative burden on both sponsors and the regulator.

• Information Management: Renewals are managed through a detailed submission roadmap (Annexure B, 2023–2035) and must follow specific windows detailed in each applicant’s renewal schedule.

Renewal Process

1. Timeline

   • Renewal applications must be submitted six months before expiry of the product’s registration.

   • Proof of payment of renewal fees must accompany submissions.

2. Consequence of Non-Compliance

   • If a renewal application is incomplete or late, the registration expires.

   • Expired registrations require a new registration application, as per SAHPGL-HPA-07.

3. Roadmap

   • A 2023–2035 roadmap has been created, spreading out product renewals over 13 years to ease administrative burden.

   • Each applicant received a product-specific roadmap in July 2022, detailing renewal schedules.

   • Submissions must occur within the designated timeframe (not earlier or later), except in special cases like duplicates or clones linked to master registrations.

Renewal fees are based on a cost-to-serve analysis. A new fee structure was gazetted on 12 February 2025, and fee schedules are available on the SAHPRA website and Payment proof must be included in Module 1.2.2.1 of the submission.

Important Rules for Renewal Applications

• No variations are allowed during a renewal application (variations must follow their own process).

• No pending Temporary Authorisations (TOAs) are allowed at the time of renewal submission.

• Dormant products are not exempt from renewal. These must be maintained and updated like active products.

• A grace period until December 2025 has been granted for renewal of dormant products.

Once the renewal is approved, applicants will receive an updated certificate of registration, which will reflect the most current product information, including approved variations and manufacturing site details.

SAHPRA conducted a pilot renewal phase and the lessons from this pilot have been incorporated into updated guidelines and templates, making the process more streamlined and predictable for future submissions.

📌For more details Refer:

Medicines Certificate of Registration Renewal Implementation Framework