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South Africa (SAPHRA): Reliance Guideline

Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the regulatory process for health products. This approach leverages decisions and assessments made by other trusted regulatory authorities, facilitating faster access to essential medicines and health products.

What is the Reliance Guideline?

The Reliance Guideline is a framework that allows SAHPRA to use the regulatory decisions, assessments, and inspections conducted by other recognized regulatory authorities. This process aims to reduce duplication of efforts, expedite product approvals, and ensure the timely availability of health products in South Africa.

There has been a decision by the SAHPRA to harmonise certain SAHPRA medicine policies and procedures with those of the European Medicines Agency (EMA). SAHPRA will then reflect global best practices in terms of health product safety, quality, and effectiveness.

This guideline is intended to provide information and guidance to applicants/ HCRs on the prescribed requirements and process to be followed, in cases where a new registration or variation application is submitted to SAHPRA with the applicant/ HCR requesting a reliance-based evaluation.

This guideline applies to new registration applications for human medicines, including biologicals. The guideline is also applicable to veterinary medicines and variation applications.

SAHPRA employs several types of reliance mechanisms:

  • Full Reliance: SAHPRA adopts the regulatory decision made by another authority without conducting an independent assessment.

  • Abridged Review: SAHPRA performs a partial review, focusing on critical aspects while relying on the primary assessment conducted by another authority.

  • Verification Review: SAHPRA conducts a verification of the external authority’s decision to ensure it meets local requirements.

Clinical Trial data is crucial in supporting the safety and efficacy of the product intended for registration. During the review process the Authority considers information regarding the review status of the clinical trial with other Regulatory Authorities, as requested in the application form.

This guideline not only benefits the regulatory authority but also supports the healthcare industry and patients by facilitating quicker access to essential medicines and health products.

For more detailed information on what are the requirements to qualify for a reliance-based review, you can read the full SAHPRA Reliance Guideline here.


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