The African Centers for Disease Control and Prevention and the African Union together have called for a New Public Health Order which will safeguard the health and economic security of the continent as it strives to meet the aspirations of the Agenda 2063. A key pillar of this mandate seeks to expan...d the local manufacture of vaccines, diagnostics, and therapeutics. Presently, less than one percent of vaccines administered on the continent are manufactured locally. This places a great burden on the health systems of African countries and reduces their ability to respond to pandemics and other health crises.
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A view of global supply chains, pressure points, and implications for antimicrobial resistance response
Despite high regional demand for vaccines valued at over US$ 1 billion annually, Africa’s vaccine industry provides only 0.1% of global supply. Vaccine inequity and hoarding at the start of the pandemic, which resulted in delays in obtaining COVID-19 doses, stimulated new resolve to address future... supply security. In 2021, the AU set a target to produce and supply more than 60% of the vaccine doses on the continent by 2040.
In the last 18 months alone, more than 30 new African manufacturing projects have been announced and estimates indicate that the African vaccine market across all existing and projected novel products could range between US$ 2.8 billion and US$ 5.6 billion by 2040*, demonstrating the potential for a thriving regional industry to emerge.
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Minimizing risk of developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotic.
The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure t...hat their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
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The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys...tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys...tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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Myanmar’s transition to a market‐based economy is accompanied by rapid development of the private manufacturing sector, which has large potential for improving economic growth. The overall success of the sector, however, should not be taken for granted. Future advances will greatly depend on th...e policy and business environment in which manufacturing activities take place. It is, therefore, important to better understand the business environment and help inform policies conducive to sustainable economic growth.
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Rwanda Guidelines for variation to registered pharmaceutical products.
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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Doc. No.: INS/GDL/001-(Annexes)