RESUMEN
Margareth Ndomondo-Sigonda outlines future challenges for the East African Medicines Regulatory Harmonization initiative.
Asunto(s)
Medicina Comunitaria/legislación & jurisprudencia , Medicina Comunitaria/tendencias , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Control de Medicamentos y Narcóticos/tendencias , Farmacovigilancia , África Oriental/epidemiología , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Ensayos Clínicos como Asunto/normas , Medicina Comunitaria/normas , Predicción , HumanosRESUMEN
Access to quality-assured medical products improves health and save lives. However, one third of the world's population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.
Asunto(s)
Países en Desarrollo , Medicamentos Esenciales/provisión & distribución , Salud Global/economía , Prioridades en Salud , Humanos , Legislación de MedicamentosAsunto(s)
Medicina Comunitaria/normas , Medicina Comunitaria/tendencias , Control de Medicamentos y Narcóticos/tendencias , Calidad de la Atención de Salud/normas , Calidad de la Atención de Salud/tendencias , África Oriental/epidemiología , Antibacterianos/normas , Antimaláricos/normas , Antivirales/normas , Medicina Comunitaria/legislación & jurisprudencia , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Humanos , Calidad de la Atención de Salud/legislación & jurisprudenciaRESUMEN
The past two decades have seen important progress in access to timely, reliable, affordable, and quality-assured supplies of vaccines of global public health importance. The new vaccines developed are powerful tools to fight killers such as pneumonia, diarrhea, and cervical cancer. Global and regional financing and pooled procurement haveshortened the lag between access in high- andlower-income countries. The COVID-19 pandemic has shown that by addressing shortcomings and seizing opportunities, we can do even more. In response to COVID-19, vaccine development and access shifted from a sequential, risk-averse paradigm to a rapid approach with maximum compression of time to market while ensuring quality. Vast public investments and innovative technologies were key facilitators. The pandemic has shown that governments play a crucial role in investing in new vaccines and manufacturing capacity and sharing risks with industry. Despite impressive progress, equity in access remains elusive with important moral, economic, and health-related consequences. Global leaders are working on a new International Treaty for Pandemic Prevention, Preparedness, and Response. To apply the lessons of COVID-19, that treaty should include a new paradigm for access to vaccines in which governments agree to:This would ensure that COVID-19 catalyzes a shift toward greater access for all under Immunization Agenda 2030.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , SARS-CoV-2 , Humanos , COVID-19/prevención & control , COVID-19/epidemiología , Vacunas contra la COVID-19/provisión & distribución , Vacunas contra la COVID-19/economía , SARS-CoV-2/inmunología , Pandemias/prevención & control , Salud Global , Desarrollo de Vacunas , Salud PúblicaRESUMEN
RNA-based medicines have potential to treat a large variety of diseases, and research in the field is very dynamic. Proactively, The European Medicines Agency (EMA) organized a virtual conference on February 2, 2023 to promote the development of RNA-based medicines. The initiative addresses the goal of the EMA Regulatory Science Strategy to 2025 to "catalyse the integration of science and technology in medicines development." The conference focused on RNA technologies (excluding RNA vaccines) and involved different stakeholders, including representatives from academia, industry, regulatory authorities, and patient organizations. The conference comprised presentations and discussion sessions conducted by panels of subject matter experts. In this meeting report, we summarize the presentations and recap the main themes of the panel discussions.
Asunto(s)
ARN , Humanos , Industria Farmacéutica , Congresos como Asunto , ARN/uso terapéuticoRESUMEN
Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.