Explore the vast range of titles available.

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.

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.

Summary points * Substandard and/or falsified medical products may result in treatment failure and/or death. * The capacity to regulate medical products is key for ensuring the quality, safety, and efficacy of medical products circulating in a market. * The experience of the East African Community, during its piloting of the Medicines Regulatory Harmonization initiative, serves as a lesson for scaling up the African Medicines Regulatory Harmonization Program across the continent. * Currently, the East African Community’s Medicines Regulatory Harmonization initiative is poised to transition from a donor-funded pilot project into a self-sustaining, permanent feature of the African regulatory landscape. * Government, partner, and public support is needed for strong systems to regulate medicines in the East African Community and elsewhere in the world. With support from partners including the AU Development Agency–New Partnership for Africa’s Development, World Bank, World Health Organization, Swiss Agency for Therapeutic Products (Swissmedic), United Kingdom Department for International Development, and Bill & Melinda Gates Foundation, the initiative provided the needed technical, financial, and political advocacy support. The importance of regulatory harmonization and cooperation in ensuring access to quality versions of essential medicines is well recognized [13]. [...]in this Special Collection of 5 articles, we describe the EAC MRH initiative from its beginning through its plans for the future. Sharing information about the EAC MRH initiative is also important because it represents the first step on a path leading toward continent-wide, coordinated regulation of medicines. Since the EAC MRH initiative started, a number of other regional economic communities have launched their own regional harmonization initiatives.

Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.

Not all doctors support the Indian government’s plans to increase the number of medical staff in rural areas by launching a three year qualification, reports Soumya Shivkumar

During the social tumult of the 1960s and 1970s, the Journal opened its pages to advocates of reform in the profession and society at large, but it did not completely break with its troubled racial past.

Since the discovery of the secondary preventive benefits of antiretroviral therapy, national and international governing bodies have called for countries to reach 90% diagnosis, ART engagement and viral suppression among people living with HIV/AIDS. The US HIV epidemic is dispersed primarily across large urban centers, each with different underlying epidemiological and structural features. We selected six US cities, including Atlanta, Baltimore, Los Angeles, Miami, New York, and Seattle, with the objective of demonstrating the breadth of epidemiological and structural differences affecting the HIV/AIDS response across the US. We synthesized current and publicly-available surveillance, legal statutes, entitlement and discretionary funding, and service location data for each city. The vast differences we observed in each domain reinforce disparities in access to HIV treatment and prevention, and necessitate targeted, localized strategies to optimize the limited resources available for each city’s HIV/AIDS response.

In urban “food swamps” like San Francisco’s Tenderloin, the absence of full-service grocery stores and plethora of corner stores saturated with tobacco, alcohol, and processed food contribute to high rates of chronic disease. We explore the genesis of the Tenderloin Healthy Corner Store Coalition, its relationship with health department and academic partners, and its contributions to the passage and implementation of a healthy retail ordinance through community-based participatory research (CBPR), capacity building, and advocacy. The healthy retail ordinance incentivizes small stores to increase space for healthy foods and decrease tobacco and alcohol availability. Through Yin’s multi-method case study analysis, we examined the partnership’s processes and contributions to the ordinance within the framework of Kingdon’s three-stage policymaking model. We also assessed preliminary outcomes of the ordinance, including a 35% increase in produce sales and moderate declines in tobacco sales in the first four stores participating in the Tenderloin, as well as a “ripple effect,” through which non-participating stores also improved their retail environments. Despite challenges, CBPR partnerships led by a strong community coalition concerned with bedrock issues like food justice and neighborhood inequities in tobacco exposure may represent an important avenue for health equity-focused research and its translation into practice.

Insufficient attention has been paid to how research can be leveraged to promote health policy or how locality-based research strategies, in particular community-based participatory research (CBPR), influences health policy to eliminate racial and ethnic health inequities. To address this gap, we highlighted the efforts of 2 CBPR partnerships in California to explore how these initiatives made substantial contributions to policymaking for health equity. We presented a new conceptual model and 2 case studies to illustrate the connections among CBPR contexts and processes, policymaking processes and strategies, and outcomes. We extended the critical role of civic engagement by those communities that were most burdened by health inequities by focusing on their political participation as research brokers in bridging evidence and policymaking.