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...

SAHPRA’s Medical Devices’ Registration Update – Upcoming Feasibility Study

Virtual

The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted an awareness session on this unit’s medical device registration update on the upcoming voluntary feasibility study. Date: 19 April 2024 Time: 10:00 to 13:00 Download Presentation Download Feasibility Study Watch Recording:

SAHPRA’s Regulatory Technical Forum (RTF) Inaugural Meeting

Virtual

South African Health Products Regulatory Authority (SAHPRA) hosted the Inaugural Meeting of the Regulatory Technical Forum (RTF). Areas of discussion on the agenda included: Veterinary Medicines Complementary Medicines Pharmacovigilance Medical Devices and IVDs Allopathic Medicines Radiation Control Legislation/Guidelines for Comment or Implementation Date: 16 May...

SAHPRA’s Hybrid Stakeholder Engagement Meeting

Hybrid

The South African Health Products Regulatory Authority (SAHPRA) hosted a Hybrid Stakeholder Engagement Meeting. The meeting was held in person and via our virtual platform.   Areas of discussion on the agenda included: SAHPRA’s strategy to support local manufacturing of vaccines as per African Union...

Industry Workshop on FAQs and Common Deficiencies for APIMF Submission

Hybrid

The South African Health Products Regulatory Authority (SAHPRA) hosted an industry workshop to empower and educate you on the FAQs & Common Deficiencies for APIMF Submission. The workshop provided information to the Industry Stakeholders and APIMF holders on the SAHPRA’s current APIMF submission procedure. In...