South African Health Products Regulatory Authority

As the 2024 TOPRA foundational bursary recipient, I had the opportunity to attend the introductory to medical devices workshop from the 26th to the 28th of June 2024 , in London . The workshop focused on EU regulations and provided comprehensive learning on both IVD’s and Non-IVD’s . With thought provoking case studies in between. The following areas were discussed : - EU Medical device classification - Conformity assessment - Clinical evaluation & PMCF - ISO 13485 - Post-market Surveillance - Risk management It was eye opening to know that one word appears multiple times in the new regulations which is RISK ,this was a great take away noting that medical devices apply a general risk based approach that requires accommodating adaptability in regulatory requirements and control . A special thank you to TOPRA - The Organisation for Professionals in Regulatory Affairs and Richard Vincins for the amazing and informative workshop. As per your mission statement you are indeed doing an exceptional job to represent and promote the profession of healthcare regulatory affairs globally. #medicaldevices #sahpra #regulatoryaffairs

🌐 SAHPRA is inviting bids for a service provider to offer Wide Area Network (WAN), Internet, and Mobile Data Network services for 36 months! Deadline: 31 July 2024 at 11:00 AM. Find out more: https://bit.ly/3UrA7fB #SAHPRA #WAN #Bids2024

We are pleased to bring you an insightful podcast interview with Prof. Nicaise Ndembi, Editor-in-Chief of the open-access 'Journal of Public Health in Africa' (JPHIA). In this podcast, he delves into the pressing challenges of infectious diseases and explore the promising new era of public health on the African continent. Tune in to hear: •The growing impact and visibility of African science in public health. •Insights on tackling infectious and non-communicable diseases across Africa. •Strategic frameworks and innovative solutions from the Africa CDC. Don't miss this exclusive discussion on the new editorial, ‘The pandemic agreement: Achieving an African win for health security inequity,’ and the pivotal role of JPHIA in shaping the future of health research in Africa. This podcast is filled with expert perspectives and in-depth discussions ideal for researchers and public health professionals alike. Don't miss this exclusive discussion on the new editorial, ‘The pandemic agreement: Achieving an African win for health security inequity,’ and the pivotal role of JPHIA in shaping the future of health research in Africa. This podcast is filled with expert perspectives and in-depth discussions ideal for researchers and public health professionals alike. Listen now at https://ow.ly/I0gW50SlETy. Affiliation: Africa CDC Publisher: AOSIS European Centre for Disease Prevention and Control (ECDC) Centers for Disease Control and Prevention Nigeria Centre for Disease Control and Prevention Nigeria Health Watch South African Medical Research Council South African Health Products Regulatory Authority Dr. Jean Kaseya #OpenAccessJournal #PublicHealth #AOSIS #InfectiousDiseases

@Healthcare Professionals: SAHPRA is excited to invite you to the launch webinar for our Codeine Care Initiative (CCI) series. Our webinar series will cover various modules with our first module focused on the holistic management for pain, cough and colds. South African Pharmacy Council Independent Community Pharmacy Association Sefako Makgatho Health Sciences University (SMU) Pharmaceutical Society of South Africa 📆 10 July 2024 ⏱ 19:00 - 20:00 🎯Register here: https://bit.ly/4cqvF6H #CCIWebinarSeries #SAHPRA #StakeholderEngagement

SAHPRA is seeking bids for a Security Information and Event Management (SIEM) solution! Deadline: 27 July 2024 at 11:00 AM. Don't miss this opportunity! Find out more: https://bit.ly/3UrA7fB #SAHPRA #SIEM #Bids2024

Today marked the end of the 3 days SADC Medicines Regulatory Forum (Zazibona) Inspectors meeting and working session. Senior GMP inspectors participated in the joint review and ratification of inspections conducted jointly on behalf of SADC in Q1 and Q2. Zazibona is one of the sucess stories of harmonisation and reliance that has been running for over 10yrs. A cummulative total of almost 30 facilities to support products registrations are conducted annually. As the Team Lead (inspections coordinator) it gives me joy on behalf of the implementing agency, Medicines Control Authority Of Zimbabwe to see these great minds putting their all to ensure universal health coverage and provision of safe, efficacious and good quality medicines and ensuring faster market access to our applicants into the region. One of the key issues discussed was the issue of competency of the inspectors going foward and ways of individual NMRAs adopting the WHO competency framework and its operationalisation. Our Standard operating procedures and guidelines were streamlined to be in sync with the new Zazibona central submission procedures. #Zazibona #Hamonisation Bill & Melinda Gates Foundation Medicines Control Authority Of Zimbabwe South African Health Products Regulatory Authority Botswana Medicines Regulatory Authority Zambia Medicines Regulatory Authority (ZAMRA)

🌍 📣 Africa's regulatory environment is maturing and here is an updated map of the current state of regulatory maturity on the African continent as of June 15 2024. On 14 June 2024, Zimbabwe's Medicines Control Authority Of Zimbabwe joined South Africa's South African Health Products Regulatory Authority, Ghana's Food and Drugs Authority,Ghana, Nigeria's NAFDAC Nigeria , Egypt's Egyptian Drug Authority and Tanzania's Tanzania Medicine and Medical Devices Authority (TMDA) as level 3 maturity regulators. This means that they are well functioning regulatory agencies for vaccines and medicines. The respective areas are indicated on the map. According to World Health Organization RSS database, the Africa region has two agencies at Level 2 maturity, Rwanda FDA and Ethiopia FDA. The region's regulatory maturity is maturing one country at a time. Let's keep at it. The goal of keeping African patients safe from substandard counterfeited medical products is within reach if we keep making progress. #africa #health #healthcare #medicines #vaccines #publichealth #safemedicines #qualitymedicines #zimbabwe #ghana #southafrica #nigeria #tanzania #egypt

📢 SAHPRA is inviting Tender bids for a service provider to offer Internal Audit Services for 5 years! 📊 Deadline: 10 July 2024 at 11:00 AM. Find out more: https://bit.ly/3UrA7fB Seize this opportunity to collaborate with us! #SAHPRA #AuditServices #Bids2024

🌟 Exciting Career Opportunities at SAHPRA! We are hiring for the following positions: 🔧 Technical Officer: Medical Devices Compliance 💊 Medicine Registration Officer: Clinical Post-Registration Evaluations 📆 Closing Date: June 28, 2024 If you're passionate about regulatory compliance and clinical evaluations, apply now! Find out more: https://bit.ly/41uX9Uk #SAHPRAJobs #HealthcareCareers #ApplyNow 🏥

Exciting Career Opportunities at SAHPRA! SAHPRA is looking for talented individuals to fill the following role: 1. Human Resources Business Partner (X2) 📆 Closing Date: 28 June 2024 If you're passionate about human resources within the medicine regulatory space, apply now: https://bit.ly/3bWGG3l #SAHPRAJobs #Healthcare #ApplyNow