South African Health Products Regulatory Authority reposted this
🌍 📣 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
This is exciting news!! I observed that Nigeria's ML3 status includes both locally produced and imported products. What does this mean for the other jurisdictions where it is just stated as "medical regulation"? Does it mean that the area of medicine regulation is just for imported products? What does it mean for locally produced products? Has any benchmarking been done for medical devices and IVDs on the continent?
Where is Kenya?
Wow, congrats to Zimbabwe. Glad to note that half of all ML3 on the continent are in SADC, albeit for different areas but nonetheless still great progress.
Thanks for sharing. The job will be incomplete if we don’t figure out how to incorporate medical devices in this success story. We seem to be leaving a whole industry and critical life saving therapies behind without a simple, homogenized and access friendly pathway to have medical devices registered. I invite mfa to draw a similar map focusing on medical devices so we can work together to fix the barriers - our African patients are counting on us
We can't achieve our goals for pharmaceutical sovereignty without a strong, resilient, standards-based regulatory system. This progress in the regulatory environment is encouraging, especially as other countries move towards this level.
This is a great graphic by Medicines for Africa. Please keep updating. Always a pleasure reading your articles. Keep it up
Where does Kenya PPB stand?
Asking for a friend, where is PPB?
Manager of AUDA NEPAD SANBio & Extraordinary Professor at North-West University at North-West University / Noordwes-Universiteit
1moCongratulations to SA, Zimbabwe and Tanzania for representing the SADC region as well. A few weeks ago, I saw Zimbabwe and SA regulators signing an MoU, I am so proud of us. The challenge now is to facilitate manufacturing and registration of locally made products including traditional medicine and biologics. Three legs to be looked at as: strong R&D, Strong Business and Strong Regulation. Lets get the first 2 legs to grow as well, otherwise the thee-legged pot will not be stable. I know we can do it and can be a hub for pharma in our region. Lets go modular and produce enough for our consumption and push pooled procurement. Together we shall prosper. Council for Scientific and Industrial Research (CSIR) SADC Secretariat Rachel Chikwamba Southern Africa Network for Biosciences - NEPAD SANBio African Union Development Agency-NEPAD Ketlareng Polori (PhD Candidate) Sechaba Bareetseng