Webinar on Strengthening Regulatory Oversight Through Improved Manufacturer Visibility
July 29 @ 3:00 pm - 5:00 pm
The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to attend a webinar on Strengthening Regulatory Oversight Through Improved Manufacturer Visibility.
The webinar will provide an overview of SAHPRA’s initiatives aimed at enhancing regulatory oversight through improved visibility of manufacturers and associated suppliers across the supply chain. Stakeholders will be informed of new data collection requirements, regulatory processes, and expectations that support risk-based oversight, inspection planning, and compliance monitoring.
Webinar Objectives
- Inform industry stakeholders about SAHPRA’s initiative to establish a structured database of API manufacturers, FPP manufacturers, FPRCs, and associated suppliers.
- Explain how the information collected will support GMP oversight, reliance activities, certificate monitoring, risk assessment, and inspection planning.
- Clarify information and documentation requirements that will be requested from applicants, importers, and manufacturers.
- Brief GDP/HCR licence holders on the low-risk site resolution and exemption process.
- Encourage industry participation and the timely submission of information required by the Inspectorate.
- Provide an opportunity for stakeholders to engage directly with SAHPRA officials and seek clarification on regulatory expectations.
We encourage all relevant stakeholders to participate in this important engagement.