Regulatory Blog

South Africa continues to strengthen regulatory efficiency and regional collaboration through structured reliance pathways. The SAHPRA Medical Devices Reliance Guideline and the ZAZIBONA Centralised Procedure – SAHPRA’s Reliance Process  collectively demonstrate SAHPRA’s commitment to regulatory convergence within the SADC region. Guidance: Medical Devices Reliance Guideline – SAHPRA’s Structured Reliance Framework The Medical Devices Reliance Guideline outlines the principle

In January 2026, the South African Health Products Regulatory Authority (SAHPRA) issued an important communication to stakeholders regarding Type II variation applications submitted under the Type II Pilot Programme. The update provides clarification on submission window compliance and temporary fee processing arrangements due to a system-related pricing limitation in the SAHPRA Engagement Portal. Background and Context SAHPRA acknowledged that certain applicants experienced

The South African Health Products Regulatory Authority (SAHPRA) has issued an updated "Guideline for Destruction of Medicines and Scheduled Substances" outlining the safe and compliant destruction of medicines and scheduled substances across the country. This update aligns regulatory expectations with the Medicines and Related Substances Act (Act 101 of 1965)  and the National Environmental Management: Waste Act (2008) , reinforcing SAHPRA’s commitment to protecting public

The South African Health Products Regulatory Authority (SAHPRA) plays a pivotal role in safeguarding public health by ensuring medicines are safe, effective, and properly labelled, and by maintaining robust pharmacovigilance through adverse drug reaction (ADR) reporting. In its continuous mission to strengthen medicine safety and promote patient wellbeing, the SAHPRA has issued two crucial documents: The Guideline for Labelling of Medicines Intended for Human Use , and The Gu

On 23rd October 2025, the South African Health Products Regulatory Authority (SAHPRA) continues to strengthen its regulatory framework to ensure that all medicines—whether registered, imported, or accessed under exceptional circumstances—meet the highest standards of safety, quality, and efficacy. Two of SAHPRA’s most recent guidance documents, namely the Guideline for Section 21 Access to Unregistered Medicines  and the Quality and Bioequivalence Guideline , play a pivotal r

On 26th August, 2025 the South African Health Products Regulatory Authority (SAHPRA) has introduced a structured framework for the...

Artificial Intelligence (AI) and Machine Learning (ML) are transforming healthcare globally, offering powerful tools for diagnosis,...

The South African Health Products Regulatory Authority (SAHPRA) has updated its Guideline " Section 21 Access to Unregistered Medicines "...

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry " Regulatory Information...

The South African Health Products Regulatory Authority (SAHPRA) has released an updated " Guideline for the Classification of Medical...

The South African Health Products Regulatory Authority (SAHPRA) has updated its " Fee Schedule and Explanatory Notes "  to renew human...

The South African Health Products Regulatory Authority (SAHPRA) is responsible for monitoring, evaluating, and regulating the renewal of...

The South African Health Products Regulatory Authority (SAHPRA) has issued comprehensive guidelines to streamline the reporting of...

The South African Health Products Regulatory Authority (SAHPRA) has issued a Communication to the industry on the process for the...

The South African Health Products Regulatory Authority (SAHPRA) has released two crucial guidelines to streamline adverse event reporting...

The SAHPRA released a " Communication to Industry on Quality Variations " document that addresses updates on the submission requirements...

As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...

The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...

The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...

The South African Health Products Regulatory Authority (SAHPRA) has released a comprehensive "Guideline on Co-applicancy". This guidance...