National Agency for Food and Drug Administration and Control (NAFDAC)’s Post

Advancing Antimicrobial Stewardship: ASTEP & NASPP Project Meeting: A significant strategic session today with our distinguished grant collaborators: Prof. Moji Christianah Adeyeye (DG, NAFDAC) Pharmacist Ibrahim Babashehu Ahmed (Registrar, PCN) Prof. Martins Emeje (DG, NNMDA) The synergy of Nigeria's drug regulatory authority (NAFDAC), pharmacy practice regulator (PCN), and natural medicine research agency (NNMDA) brings crucial oversight, professional development, and research expertise to this antimicrobial stewardship initiative. This CIHR-funded project - Antimicrobial Stewardship Education for Pharmacists (ASTEP) and National Antimicrobial Stewardship Pilot Program (NASPP) - is uniting researchers and collaborators from National Agency for Food and Drug Administration and Control (NAFDAC), Pharmacy Council of Nigeria (PCN), Nigeria Natural Medicines Development Agency (NNMDA), University of Waterloo Faculty of Health, University of Ottawa, University of Abuja Teaching Hospital with implementation support from International Research Center of Excellence_IHVN (IRCE). Today's meeting focused on strategic planning and establishing working relationships between agency directors and research teams. Looking forward to this collaborative journey in strengthening healthcare systems! #GlobalHealth #AntimicrobialStewardship #HealthcareResearch #CIHR #NAFDAC #PCN #NNMDA #IRCE

DYK: Only six regulators in Africa have achieved WHO Maturity Level 3 (ML3), the mark of a stable, well-functioning regulatory system. According to the African Union Development Agency-NEPAD more than 90% of National Regulatory Authorities (NRAs) on the continent lack capacity to provide effective oversight of medicines and medical products. We’re proud to work with Bill & Melinda Gates Foundation to expand regulatory maturity across Africa by supporting Food and Drugs Authority,Ghana to become a continental regulatory training hub. The hub will help build regulatory capacity and develop a skilled regulatory workforce in Africa while protecting patients from poor quality products. Learn more about the project: https://ow.ly/6Rrq50TA52L

Knowing more about the challenges of falsified and substandard medicine in the SADC region is interesting.

ClinRegs has updated the Kenya profile. "The Kenya profile in ClinRegs has been reviewed and updated with the following information: * Minor revisions to the Pharmacy and Poisons Board (PPB) guidance for the conduct of clinical trials, including an updated definition of investigational product, name change for the PPB clinical trial division, and renumbered sections (See Submission Process, Timeline of Review, and Definition of Investigational Product) * Updated National Commission for Science, Technology and Innovation (NACOSTI) instructions on paying for a research license and using the online payment platform, eCitizen (See Regulatory Fees) * PPB guidance on a standardized approach for evaluating and reporting the balance between the benefits and risks of health products during clinical trials (See Risk & Quality Management) * Details on Kenya’s research information system (KENRIS) which supports researchers, institutions, and ethics committees (See Oversight of Ethics Committees and Site/Investigator Selection) * PPB guidance on good manufacturing practices (See Manufacturing & Import) "For a detailed listing of sources added or revised during this update, see the Kenya updates page." #NIAID #ClinRegs #ClinicalTrials #ClinicalResearch #Kenya https://lnkd.in/ex9fHvx4

Recently, I had the privilege of addressing The Guild of Medical Laboratory Directors of Nigeria, with representatives of USAID and FHi 360. It was a convergence of major stakeholders in the private sector of Medical Diagnostics across the country, and the focus of our dialogue was toward (1) goal; Improving the current scope of Molecular Biology & Viral Load assays in Nigeria. Considering the dynamic challenges surrounding our quest for Quality, Affordability and accessibility of medical diagnostic services, it was refreshing to see the wealth of wisdom being shared in the room. In my short discourse, i emphasized 3 important things 1. The necessity of paying the Cost Of Quality because the consequences that accompany the Cost Of Poor Quality are too dire to ignore. 2. The need to inculcate and encourage Lean principles. As the only way to secure the resources needed to achieve our desired goal, is to ensure the ones we have are used efficiently. 3. The importance of fostering more interpersonal relationships among private establishments, for synchronized prevalence monitoring, Process improvement and skill development. It was a privilege. #Management #Healthcare #Monitoring #QualityManagement #QualityAssurance

#Senegal and #Rwanda achieve #WHO Maturity Level 3 in medicines regulation: Senegal and Rwanda have become the seventh and eighth countries in Africa to reach Maturity Level 3 (ML3) in WHO's global classification of national regulatory authorities, underscoring their commitment to ensuring safe, effective and high-quality medical products for their populations. Other countries at ML3 in Africa are #Egypt, #Ghana, #Nigeria, #SouthAfrica, #Tanzania and #Zimbabwe.

The African Medicines Regulatory Harmonization (AMRH) initiative has made impressive strides in transforming regulatory systems across Africa. A shining example is the ZaZiBoNa initiative, which has enabled faster access to medicines in Southern Africa. Yet, challenges remain, particularly in achieving simultaneous access to multiple markets. While joint reviews are speeding things up, the final registration still lies with individual countries, creating delays. But the future is promising, with efforts to centralize submissions and align processes across regions. To fully unlock Africa's potential, investment in robust information systems and greater transparency will be key. ZaZiBoNa’s success is a sign of what’s possible with regional cooperation. Now, it's time to push further and ensure all African countries can benefit from faster, safer access to medicines. #ZaZiBoNa #AMRH #Medicines #Regulation #Pharmaceuticals #Africa #Healthcare #Innovation #CapacityBuilding #Harmonization

NAFDAC Cracks Down on Counterfeit Medicines! NAFDAC, under the leadership of Prof. Mojisola Adeyeye, has taken a strong stance against the production and distribution of falsified medicines. Three individuals and Giddyson Healthcare Limited have been arraigned before the Federal High Court, Kano, for these crimes. The Charges: Manufacturing, distributing, and selling substandard and falsified medicines. Producing counterfeit medicines with ZERO active ingredients - a serious threat to public health. The Falsified Products: Asian Ampicillin Erythromycin Artil-Go suspension for children (all lacking essential ingredients) The Illegal Operation: Uncovered and sealed following an investigation in Tafa town, Niger State. Products unregistered with fake NAFDAC numbers and manufacturer addresses. Endanger patients by causing treatment failures and potential deaths. NAFDAC's Commitment: Maintains a zero-tolerance policy for such actions. Seeks public cooperation in eradicating falsified medicines in Nigeria. Prof. Adeyeye urges Nigerians to report any suspicious activities. Together, let's ensure the safety and well-being of all Nigerians! #NAFDAC #Healthcare #PublicHealth #FalsifiedMedicines #Nigeria

Medicine Control Authority of Zimbabwe (MCAZ) has published circular (no, 6 of 2024) regarding revised procedure for receiving and processing variation applications. The authority warned that scanned documents for the entire submission will result in rejection of applications. Applicants are advised to consult MCAZ guidelines and the requirements in this circular (attached) before submission variation applications in Zimbabwe market #zimbabwe #regulatoryaffairs #regulatory #regulatorycompliance #regulatoryupdates #regulatoryrequirements #drugs #variation #regulatorysubmissions #dossier #regulatorychallenges #cmc