medicines for africa (mfa)

📢🌍 Safety alert in Ethiopia -attention for health professionals❗ Novartis, the market authorization holder/manufacturer of Tegretol Oral Suspension has notified the Ethiopian Food and Drug Authority (EFDA) that Tegretol!® (carbamazepine) 100 mg/5ml Oral Suspension (OS), a product usually used for the management of generalized tonic-clonic and partial seizures, is no longer recommended for neonates (below 4 weeks of age for term babies or 44 weeks post-menstrual age for pre-term babies) due to the amount of propylene glycol (PG) in this formulation. Refer to the circular below dated 6/11/2024 #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #ethiopia

🌍 Chad kicked off an ambitious triple vaccine rollout a few days ago, including the R21 malaria vaccine, marking a significant step forward in its efforts to safeguard the health and well-being of millions of children. Along with the World Health Organization (WHO)-recommended R21 malaria vaccine, Chad is simultaneously rolling out PCV13 pneumococcal conjugate and rotavirus vaccines, targeting 19.7 million children aged between six months and five years, among them 168 522 (aged between six and 15 months) will receive the malaria vaccine being introduced in 28 priority districts. This is important progress for Chad and its children who will be protection through vaccination. 🔗 More info: https://lnkd.in/eJ-gairS #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #chad

🌍 💡Rwanda has been stepping up measures to combat Rift Valley Fever (RVF) following the country’s second outbreak in two years, amid concerns it could spread to humans, but delayed screening and testing may have contributed to the spread of the disease which highlights the urgent need for rapid and accurate diagnostic tools according to Rwagasore Edson, co-author of the study and division manager for public health surveillance and emergency preparedness and response at the Rwanda Biomedical Centre. The re-emergence of the disease among livestock, near the border with Tanzania, sparked fears of a repeat of the 2022 outbreak, in which more than 20 people and hundreds of animals died. RVF is a viral disease that primarily affects animals but can also infect humans. No human-to-human transmission has been reported to date. The virus is spread through the bites of infected mosquitoes and through contact with the blood or organs of infected animals. This includes consuming raw meat or unpasteurised milk from infected animals. 🔗 Know more: https://lnkd.in/eyjE66Di #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #mosquitos #riftvalleyfever #rwanda

📣The Egyptian Drug Authority (EDA), and the South African Health Products Regulatory Authority (SAHPRA), are inviting industry partners to participate in the pilot phase of their bolateral Work Sharing Initiative (WSI) to streamline the registration process for biological products in both countries through joint assessment. South Africa and Egypt consider the collaboration of stakeholders in the pharmaceutical and biotechnology sectors critical to the success of this initiative. Industry partners who participate in this joint assessment initiative will have the opportunity to: 1️⃣ Collaborate with the leading African regulatory authorities to shape the future of regulatory policies and practices.  2️⃣ Contribute to the development of regulatory frameworks that support mutual reliance and access to medicines and vaccines. Industry stakeholders are invited to express their interest in participating in this initiative by submitting a formal application after reviewing the concept paper of the initiative and its operating procedures through the links below. ⏰ Deadline to receive your application: 28th February 2025 📨 Email: EDA: Bioreg.rec@edaegypt.gov.eg  SAHPRA: eoi@sahpra.org.za WSI_Concept Note: https://lnkd.in/eHfJPuDS WSI_Annex I_Application Form: https://lnkd.in/esAChqiv WSI_Annex II_Operating Procedures: https://lnkd.in/eXrcwHhZ #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda

🌍More African national regulatory authorities (NRAs) relying on each through deeper more meaningful collaboration can build confidence and drive regulatory harmonisation. This can be greatly facilitated by making the reports of WHO global benchmarking decisions public. Doing so could help to strengthen relationships between regulatory agencies and promote regulatory harmonization. However, out of six African NRAs that have been successfully benchmarked as stable, well-functioning and integrated agencies at maturity level 3 (ML3) that is Egypt and South Africa (for vaccines) or Ghana, Nigeria, Tanzania and Zimbabwe (for medicines), only one - Zimbabwe, has made its report public. As the African continent strives to harmonize medicines regulation, we propose that all countries that undergo global benchmarking making their reports public. Not doing so is a missed opportunity to catalyse deeper meaningful engagement and exchange between NRAs. 🔗 Read the article: https://lnkd.in/ehd8AJQH #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda

Today in Utano, some food for thought on factors holding back regulatory development in Africa. When it comes to the development of medicines regulation in African countries, there is no shortage of ambition amongst the region’s national medicines regulatory agencies (NRAs. The continent of Africa is brimming with it. Though finance has is believed to be the biggest impediment to NRA success, it may be a limiting belief that can be overcome. Regulatory excellence is more than about having meticulous systems and processes on paper if those are not applied into regulatory practice. Regulatory maturity and excellence is about practice. Small steps taken consistently. It takes a painstaking process of critical self-evaluation, course correction and continuous improvement. It is built over time. 🔗 Read the article: https://lnkd.in/eWcX5RBj #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #zimbabwe #southafrica #ghana #tanzania #egypt

In response to declaration of M. pox as public health emergency of international concern (PHEIC), In order to expedite market authorization of in-vitro diagnostics (IVDs) for testing Mpox, the Pharmacy and Poisons Board is inviting applicants to submit product dossiers to the Pharmacy and Poisons Board via the Pharmaceutical Regulatory Information Management portal . The PPB seeks to ensure access to public health emergency health products and technologies that conform to prescribed standards of quality, safety and efficacy. The application should be accompanied by a sample size of 400 test kits and payment of the prescribed fees of 2,500 USD. For more information, read document attached below. https://lnkd.in/ddVuV8Mx. #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #kenya

Medicines for Africa congratulates Egypt on being certified malaria-free by World Health Organization marking a significant publichealth milestone for a country with more than 100 M inhabitants. The achievement follows a nearly 100-year effort by the Egyptian government and people to end a disease that has been present in the country since ancient times. relook forward to more African countries reaching this milestone. 🔗 https://lnkd.in/eNWJTnEA #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #egypt

The governments of Malawi and India have signed a Memorandum of Understanding (MoU) on pharmacopoeial cooperation. The signing of the MoU on Friday at Kamuzu Palace was part of bilateral talks between His Excellency President Dr. Lazarus McCarthy Chakwera and his Indian counterpart President Smt. Droupadi Murmu - 15th President of Republic of India. The Indian President is in Malawi for a three-day state visit. Among key areas under the agreement is to enhance cooperation in pharmacopoeia standards, specifically promoting understanding of Indian Pharmacopoeia (IP) in regulatory frameworks, requirements, and processes, considering that a significant proportion of medicines consumed in Malawi are manufactured in India. 🔗 More info: https://lnkd.in/eQpZGUNe. #africa #medicines #vaccines #diagnostics #medicaldevices #health #healthcare #publichealth #pandemic #arvs #qualitymedicines #safemedicines #substandardmedicines #counterfeitedmedicines #diabetes #insulin #ncds #medicinesforafrica #southafrica #zimbabwe #Rwanda #leniashwenda #malawi #india

The 19th International Conference of Drug Regulatory Authorities (ICDRA) just concluded in New Delhi, India, representatives of more than 120 national regulatory authorities for therapeutic products as well as numerous international organisations where they were meeting under the auspices of the World Health Organization. The main topic was smart regulation of medical products and how international cooperation and the use of reliance mechanisms in the field of medicines and medical devices can be further expanded. Regulatory leaders explored what is going well and what can be done better and Richard Tendayi Rukwata, the head of the Medicines Control Authority Of Zimbabwe made some remarks about the WHO global benchmarking process. 🔗Listen to his remarks: https://lnkd.in/eB3AXPUw