🌍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
Let’s go back to the basics: Why has the evaluation of NRAs not been presented in the public arena? What has been the reason? I see that both WHO and its member states have a position to make on this matter, particularly if we understand the logic applied for making or not making these processes and results public. It would be good to hear from the NRA in Zimbabwe, on whether the decision was autonomous (ie, not infringing on any national law for making results public). And also whether WHO is expected to respect any existing agreement with each member state whose NRA the WHO evaluates.
Joseph Mthetwa
3mo
The arena for Regulatory Affairs in Africa is not even. There seem to be some salient competition rather than coordination and collaboration in the area/field of regulation i.e in registration and control of medicines and medical devices. The current legal status for addressing and sharing National Information is governed by confidentiality clauses embedded in the existing laws. These laws prohibit countries from sharing publicly sovereign information. Therefore, not until such pieces of legislature get repealed it will perpetually impossible for some countries to publicly publish such information. The level of autonomy of the NMRA matters in this case. WHO may need to strengthen its presence in as far as Pharmaceutical regulation is concerned at country level both in terms of programme and staff presence. Currently there are very few countries that have Regulatory Experts presence at country level not even at WHO Afro level. Regulatory Teams are broadly based in Geneva, Switzerland. There is need for Strengthening Pharmaceutical Regulatory Capacity at WHO AFRO and at WHO Country Office level for harmonization and integration to be realised.
Very informative and helpful. African countries should make their regulatory formulary public and not secrecy. South Africa has South African Medicine Formulary (SAMF); which is being used in developed nations like Canada, Australia, Zealand etc.
Internal Medicine (TB &HIV, DM)
3moIf there were no hidden agenda, why is it that every Africa government dwell in secrecy including Nigeria especially Ministry of health or department? Are they afraid of peer review mechanisms? Or pharmacopia used are outdated? Other African countries should learn from South Africa government in terms of medicine formulary.