The South African Health Products Regulatory Authority (SAHPRA) hosted the third industry workshop in a series of informative sessions around eCTD. This webinar focused on Specification 3.1 processes. The processes covered included: Baselines-Iterative TOA Splitting the eCTD Multiple applications (replicas, clones, and duplicates) Line Extensions...
The South African Health Products Regulatory Authority (SAHPRA), together with the SADC SF Group, were excited to extend a special invitation to you for the SADC SF Group Webinar on Substandard and Falsified Health Products: situational analysis and collaborations. Key Highlights: Broader awareness and status...
The South African Health Products Regulatory Authority (SAHPRA) hosted the launch of the SAHPRA Engagement Portal. The expected outcomes: Overview Account administration Training Who attended? Industry stakeholders Presentation Download Presentation Watch Recording
The South African Health Products Regulatory Authority (SAHPRA) hosted industry stakeholders at the Regulatory Technical Forum (RTF) Meeting. Areas discussed on the agenda included: EOI on model dossiers for training BAU applications and variations Medicines (Allopathic) Veterinary Medicines Complementary Medicines Inspectorate and Regulatory Compliance Medical...
The South African Health Products Regulatory Authority (SAHPRA), in collaboration with the World Health Organization (WHO), recently hosted a webinar to introduce the WHO Pilot on the Implementation of the National Action Plan for combating substandard and falsified (SF) medical products in South Africa. The...
As part of its pharmacovigilance programme, the South African Health Products Regulatory Authority (SAHPRA) recently partnered with the Independent Community Pharmacy Association (ICPA) to deliver an informative webinar on reporting adverse drug events and promoting the safe use of medicines to reduce the occurrence of...
The South African Health Product Regulatory Authority (SAHPRA) Complementary Medicines’ (CMs’) Hybrid Workshop successfully took place, offering attendees the option to participate either in person or via a virtual platform. Key areas discussed during the workshop included: SAHPRA responded to the 21 questions regarding Complementary...
The Medical Devices Unit of the South African Health Products Regulatory Authority (SAHPRA) hosted a consultative meeting with Industry. The meeting aimed to communicate updates, ensure compliance with legislative requirements, discuss improvements to the application process, and enhance overall client service and relations. Areas of...
The Radiation Control’s Licencing Unit of the South African Health Products Regulatory Authority (SAHPRA) invites you their Veterinary Licence Compliance Webinar to aid support, guidance and encourage compliance within the veterinary community. Areas of discussion include: Improve your understanding of veterinary sector compliance with the...
The South African Health Products Regulatory Authority (SAHPRA) recently hosted its Regulatory Technical Forum (RTF) Meeting, bringing together key industry stakeholders to discuss regulatory updates. Areas of discussion on the agenda included: BAU Applications and Variations Medicines (Allopathic) Veterinary Medicines Complementary Medicines Inspectorate and Regulatory...
The South African Health Products Regulatory Authority (SAHPRA) is launching an online applications platform. This platform hosted several application processes, which are enabled across different phases in the overall implementation of their engagement platform. What was covered?: How does the portal work How to submit...
The South African Health Products Regulatory Authority (SAHPRA) hosted an educational and informative webinar to provide broader awareness of the SAHPRA Engagement Portal. This webinar session focused on the submission of Section 21 applications for Category A Medicines (also known as Orthodox or allopathic medicines)....
