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
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-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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Antimicrobial resistance is one of the most important threats to the health worldwide. Antimicrobial resistance or drug resistance is the reduction of the pharmaceutical effects of a drug against a disease or reduction of its effectiveness in improv
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ing the clinical signs of a disease. Antimicrobial resistance occurs naturally but misuse of antibiotics in human and animals significantly accelerates the process of developing antimicrobial resistance. In fact, antimicrobial resistance refers to the resistance of a microorganism to one or more antimicrobial drugs which had been previously sensitive to these drugs. Antimicrobial resistance can occur in a wide variety of pathogens including bacteria, parasites, viruses, fungi, and cancer cells and may threaten the life of every person, in every age, and in every country
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr
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am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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2016 ASCO EDUCATIONAL BOOK | asco.org/edbo
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically
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assist national medicines regulatory authorities to understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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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 Ins
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pection 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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This third booklet of the World Drug Report 2022 has a dual focus: opioids and cannabis.
The first chapter of the booklet provides an overview of opioids as a group of substances and their patterns of non-medical use at the global level. It also reviews the latest trends in the global supply of opi
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ates and synthetic opioids and the availability of pharmaceutical opioids for medical consumption. Issues specific to regional patterns and trends in opioid markets are also analysed, including the opioid crisis in North America and in Africa and the Middle East. The chapter also includes a discussion of the potential impact, in the region and worldwide, of changes in opium poppy cultivation and opium production in Afghanistan. reireg
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This situation analysis has gathered information about the current state of AMR, contributing factors and antimicrobial use in Zimbabwe from the human, animal, agricultural and environmental sectors. Data has been gathered from different sectors such as the general public, academia, the Ministry of
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Health and Child Care, the Ministry of Agriculture Mechanization and Irrigation Development and the Ministry of Environment, Water and Climate. It shows that AMR is a real concern in Zimbabwe and a threat to the health outcomes of humans, to the economic productivity of the livestock industry and a risk to the environment.
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The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National
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Health Policy. The pharmacy policy addresses, among other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o
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ver antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj
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ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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The Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted unanimously by all Member States in 2011. It brings together Member States, industry, other stakeholders and WHO to implement a global approach to pand
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emic influenza preparedness and response. The Framework includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.
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