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Independent, science-based regulation of medical products is a critical part of ensuring quality healthcare and, when conducted in a transparent, science-based, efficient, accountable, and predictable manner, it can help ensure access to quality products that patients need and can have a very positive impact on public health. [...]African countries must contend with 75% of the world’s HIV/AIDS cases and 90% of its malaria deaths, and access to quality versions of the newest and most effective medicines is key in treating these infections [8], as well as in disease control strategies. The consortium included regulatory and political bodies (AUDA-NEPAD, PAP, the African Union Commission, the Heads of NMRAs, the Joint United Nations Programme on HIV/AIDS), the World Bank, technical partners (WHO, the Swiss Agency for Therapeutic Products [Swissmedic]), and donors (the Bill & Melinda Gates Foundation, the Clinton Health Access Initiative, the UK Department for International Development) [12]. At this time, there was only sufficient funding for the consortium to support one pilot project. [...]the consortium decided to solicit proposals from each of the RECs and fund the most promising plan for MRH over the next 5 years.

(Drug-induced extrapyramidal side effects are movement disorders with acute and long-term symptoms, including dystonia, akathisia, parkinsonism, bradykinesia, tremor, and tardive dyskinesia.) Without the help of the eight sub-Saharan African countries that submitted reports to VigiBase, it is unclear whether the association between the medicine combination and this adverse event would have been detected. Because of the countries’ vigilance, healthcare providers can now be alert for these reactions and treat them promptly. Unfortunately, due to a number of factors, including inadequate legal framework and infrastructure, limited financial resources, and the number and competency of staff available to support pharmacovigilance systems, many African countries struggle to gather and report information about suspected adverse events, which is key for monitoring the safety of medicines on the market. CRO, contract research organization; EAC, East African Community; GMP, good manufacturing practice; ISO, International Organization for Standardization; IVD, in vitro diagnostic; JA, joint assessment; MRH, Medicines Regulatory Harmonization; NMRA, national medicines regulatory authority; PV, pharmacovigilance; RTO, regional technical officer; WHO, World Health Organization. https://doi.org/10.1371/journal.pmed.1003129.g001 To ensure that all the program’s priorities are being championed, each NMRA now has one RTO, each of whom specializes in a different area. [...]once a product has been recommended through the joint assessment process, the RTO will follow up with NMRAs to ensure that national registrations proceed in a timely manner.

Background East Africa is home to 170 million people and prone to frequent outbreaks of viral haemorrhagic fevers and various bacterial diseases. A major challenge is that epidemics mostly happen in remote areas, where infrastructure for Biosecurity Level (BSL) 3/4 laboratory capacity is not available. As samples have to be transported from the outbreak area to the National Public Health Laboratories (NPHL) in the capitals or even flown to international reference centres, diagnosis is significantly delayed and epidemics emerge. Main text The East African Community (EAC), an intergovernmental body of Burundi, Rwanda, Tanzania, Kenya, Uganda, and South Sudan, received 10 million € funding from the German Development Bank (KfW) to establish BSL3/4 capacity in the region. Between 2017 and 2020, the EAC in collaboration with the Bernhard-Nocht-Institute for Tropical Medicine (Germany) and the Partner Countries’ Ministries of Health and their respective NPHLs, established a regional network of nine mobile BSL3/4 laboratories. These rapidly deployable laboratories allowed the region to reduce sample turn-around-time (from days to an average of 8h) at the centre of the outbreak and rapidly respond to epidemics. In the present article, the approach for implementing such a regional project is outlined and five major aspects (including recommendations) are described: (i) the overall project coordination activities through the EAC Secretariat and the Partner States, (ii) procurement of equipment, (iii) the established laboratory setup and diagnostic panels, (iv) regional training activities and capacity building of various stakeholders and (v) completed and ongoing field missions. The latter includes an EAC/WHO field simulation exercise that was conducted on the border between Tanzania and Kenya in June 2019, the support in molecular diagnosis during the Tanzanian Dengue outbreak in 2019, the participation in the Ugandan National Ebola response activities in Kisoro district along the Uganda/DRC border in Oct/Nov 2019 and the deployments of the laboratories to assist in SARS-CoV-2 diagnostics throughout the region since early 2020. Conclusions The established EAC mobile laboratory network allows accurate and timely diagnosis of BSL3/4 pathogens in all East African countries, important for individual patient management and to effectively contain the spread of epidemic-prone diseases.

According to the World Health Organization (WHO) [1], NMRAs contribute to promoting and protecting public health and safety by ensuring that. * medicines are of the required quality, safety, and efficacy; * health professionals and patients have the necessary information to enable them to use medicines rationally; * medicines are appropriately manufactured, stored, distributed, and dispensed; * illegal manufacturing and trade are detected and adequately sanctioned; * promotion and advertising are fair, balanced, and aimed at rational drug use; and * access to medicines is not hindered by unjustified regulatory work. Afterward, the medicines were registered by Kenya and Uganda (although the medicines were eligible for registration in all EAC countries, the manufacturer decided to register them in only 3). Because of this new regional approach to product assessment, these medicines were available in EAC countries sooner than they would have been otherwise. [...]the EAC MRH initiative was expected to identify a funding mechanism that would allow it to sustain and broaden its regulatory activities after the catalytic donor support available for the first 5 years expired. The initiative’s Medicines Evaluation & Registration Working Group, led by Tanzania’s NMRA, created this CTD as part of the program’s larger mandate of harmonizing technical requirements, standards, and standard operating procedures (SOPs) for medicines assessment and registration across the region [8]. Because the EAC’s CTD is based on the formats used by ICH and the WHO’s Prequalification Programme, EAC Partner States can easily leverage dossiers previously submitted to other regulatory authorities, such as the WHO, US Food and Drug Administration, or European Medicines Agency.

Background Medical devices and in vitro diagnostic tests (IVD) are vital components of health delivery systems but access to these important tools is often limited in Africa. The regulation of health commodities by National Regulatory Authorities is intended to ensure their safety and quality whilst ensuring timely access to beneficial new products. Streamlining and harmonizing regulatory processes may reduce delays and unnecessary expense and improve access to new products. Whereas pharmaceutical products are widely regulated less attention has been placed on the regulation of other health products. A study was undertaken to assess regulation of medical diagnostics and medical devices across Partner States of the East African Community (EAC). Methods Data was collected during October 2012 through desk based review of documents and field research, including face to face interviews with the assistance of a structured questionnaire with closed and open ended questions. Key areas addressed were (i) existence and role of National Regulatory Authorities; (ii) policy and legal framework for regulation; (iii) premarket control; (iv) marketing controls; (v) post-marketing control and vigilance; (vi) country capacity for regulation; (vii) country capacity for evaluation studies for IVD and (viii) priorities and capacity building for harmonization in EAC Partner States. Results Control of medical devices and IVDs in EAC Partner States is largely confined to national disease programmes such as tuberculosis, HIV and malaria. National Regulatory Authorities for pharmaceutical products do not have the capacity to regulate medical devices and in some countries laboratory based organisations are mandated to ensure quality of products used. Some activities to evaluate IVDs are performed in research laboratories but post market surveillance is rare. Training in key areas is considered essential to strengthening regulatory capacity for IVDs and other medical devices. Conclusions Regulation of medical devices and in vitro diagnostics has been neglected in EAC Partner States. Regulation is weak across the region, and although the majority of States have a legal mandate to regulate medical devices there is limited capacity to do so. Streamlining regulation in the EAC is seen as a positive aspiration with diagnostic tests considered a priority area for harmonisation.

The East African Integrated Disease Surveillance Network (EAIDSNet) was formed in response to a growing frequency of cross-border malaria outbreaks in the 1990s and a growing recognition that fragmented disease interventions, coupled with weak laboratory capacity, were making it difficult to respond in a timely manner to the outbreaks of malaria and other infectious diseases. The East Africa Community (EAC) partner states, with financial support from the Rockefeller Foundation, established EAIDSNet in 2000 to develop and strengthen the communication channels necessary for integrated cross-border disease surveillance and control efforts. The objective of this paper is to review the regional EAIDSNet initiative and highlight achievements and challenges in its implementation. Major accomplishments of EAIDSNet include influencing the establishment of a Department of Health within the EAC Secretariat to support a regional health agenda; successfully completing a regional field simulation exercise in pandemic influenza preparedness; and piloting a web-based portal for linking animal and human health disease surveillance. The strategic direction of EAIDSNet was shaped, in part, by lessons learned following a visit to the more established Mekong Basin Disease Surveillance (MBDS) regional network. Looking to the future, EAIDSNet is collaborating with the East, Central and Southern Africa Health Community (ECSA-HC), EAC partner states, and the World Health Organization to implement the World Bank-funded East Africa Public Health Laboratory Networking Project (EAPHLNP). The network has also begun lobbying East African countries for funding to support EAIDSNet activities.