Upcoming Workshop: QOS/QIS and Variation Validation Template

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted a workshop to share useful information on populating the QOS and QIS as a replacement for the SCoRe document, as well as information on the Variations Validation template. Date: 22 May 2023 Time: 09:00 - 11:00 Watch Recording

Webinar on Demystifying Hepatitis

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted an exciting conversation on Demystifying Hepatitis to bring more awareness to World Hepatitis Day, celebrated annually on 28 July. We have invited panellists from various sectors to share their knowledge, experience, and expertise to begin this important...

Radiation Control’s Regulatory Compliance Webinar

Virtual

The Radiation Control (RadCon) Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an informational webinar to increase awareness and understanding of radiation control regulatory processes. You have an opportunity to learn and engage with SAHPRA colleagues on key regulatory compliance processes within...

Webinar | Importance of Reporting Adverse Events to SAHPRA | #MedSafetyWeek

Virtual

The South African Health Products Regulatory Authority (SAHPRA) is commemorating the #MedSafetyWeek2023 campaign, in collaboration with South African Pharmacy Council (SAPC), by hosting a webinar focused on the Importance of Reporting Adverse Events. The #MedSafetyWeek is an international social media campaign organised every year by the Uppsala...

Good Regulatory Practices and Technical Competencies

Hybrid

This workshop will provide an exchange of information and capacity building between the South African Health Products Regulatory Authority, SAPHRA and partner reference NRAs including the WHO, USFDA, TGA, HSA, ANVISA, covering the core international references for medical device regulatory. The workshop objective is to...

Webinar on Virtual Fee Regulation Workshop with Industry | Revised Fee Regulations

Virtual

South African Health Products Regulatory Authority (SAHPRA) hosted a virtual workshop in the Virtual Fee Regulation Workshop with Industry. The workshop addressed the responses to public comments and proposed changes to the Revised Fee Regulations. Thu, Feb 22, 10:00 AM - 2:00 PM (CAT)   Download...

Webinar on Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted a webinar on the Awareness of Substandard & Falsified Medications in South Africa – Understanding Impact. Key Highlights: Understanding the basics of substandard and falsified medicines Identifying the dangers of consuming untested and unauthorised medicines Importance of reporting agencies/outlets...

Virtual Training Session | How to use the OTC Online Medicines Directory Toolkit

Virtual

The South African Health Products Regulatory Authority (SAHPRA), in conjunction with the Selfcare Association of South Africa, hosted a virtual training session on How to use the OTC Online Medicines Directory Toolkit. By registering, you have an opportunity to: grasp and understand how you can...

Industry Webinar | Updates on Regulatory Information Management (RIMS) Roll-Out

Virtual

The South African Health Products Regulatory Authority (SAHPRA) is hosting an Industry webinar for updates on the Regulatory Information Management System (RIMS) roll-out. What to expect? SAHPRA will start with cut-over activities during the course of March 2024 and the implementation process on 02 April 2024....

Virtual Meeting | Conformity Assessment Bodies Meeting

Virtual

The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the South African National Accreditation System (SANAS), hosted a Conformity Assessment Bodies (CABs) Virtual Meeting. What was discussed? Extension of scope of practice to include technical dossier review SANAS Accreditation process SAHPRA requirements and future...

Industry Workshop | Understanding SAHPRA’s Risk Management Plan Guidelines

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the Authority’s requirements when submitting Risk Management Plans (RMPs). This workshop highlighted the importance of maintaining RMPs to ensure the safety of medicines, while also sharing requirements for compliance....

2nd Session | Updates on Regulatory Information Management System (RIMS) Roll-Out

Virtual

The South African Health Products Regulatory Authority (SAHPRA) hosted the 2nd session of our industry webinar focused on the Regulatory Information Management System (RIMS) roll-out updates. The session was recorded and published on the SAHPRA website. A similar Update session will be held once the eSubmission specifications...