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Publication Years
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Toolboxes
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1
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
more
The manufacturing process is one of the key steps where quality control is required to ensure quality o
...
f medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
more
GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Sin
...
ce 2001, GDF has facilitated access to high-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
and delivering more than $200 million worth of diagnostic equipment
more
In 2015, the United Nations set important targets to reduce premature
cardiovascular disease (CVD) deaths by 33% by 2030. Africa disproportionately
bears the brunt of CVD burden and has one of the
...
highest risks of dying
from non-communicable diseases (NCDs) worldwide. There is currently
an epidemiological transition on the continent, where NCDs is projected
to outpace communicable diseases within the current decade. Unchecked
increases in CVD risk factors have contributed to the growing burden of three
major CVDs—hypertension, cardiomyopathies, and atherosclerotic diseasesleading to devastating rates of stroke and heart failure. The highest age
standardized disability-adjusted life years (DALYs) due to hypertensive heart
disease (HHD) were recorded in Africa. The contributory causes of heart failure
are changing—whilst HHD and cardiomyopathies still dominate, ischemic
heart disease is rapidly becoming a significant contributor, whilst rheumatic
heart disease (RHD) has shown a gradual decline. In a continent where health
systems are traditionally geared toward addressing communicable diseases,
several gaps exist to adequately meet the growing demand imposed by CVDs.
Among these, high-quality research to inform interventions, underfunded
health systems with high out-of-pocket costs, limited accessibility and
affordability of essential medicines, CVD preventive services, and skill
shortages. Overall, the African continent progress toward a third reduction
in premature mortality come 2030 is lagging behind. More can be done in
the arena of effective policy implementation for risk factor reduction and
CVD prevention, increasing health financing and focusing on strengthening
primary health care services for prevention and treatment of CVDs, whilst
ensuring availability and affordability of quality medicines. Further, investing
in systematic country data collection and research outputs will improve the accuracy of the burden of disease data and inform policy adoption on
interventions. This review summarizes the current CVD burden, important
gaps in cardiovascular medicine in Africa, and further highlights priority
areas where efforts could be intensified in the next decade with potential
to improve the current rate of progress toward achieving a 33% reduction
in CVD mortality.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac
...
ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for her ... bal medicines to improve the quality, safety and efficacy of finished herbal products; 2. guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and 3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general. These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations. more
1. contribute to the quality assurance of medicinal plant materials used as the source for her ... bal medicines to improve the quality, safety and efficacy of finished herbal products; 2. guide the formulation of national and/or regional GACP guidelines and GACP monographs for medicinal plants and related standard operating procedures; and 3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general. These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations. more
Malar J 23, 333 (2024). https://doi.org/10.1186/s12936-024-05165-w.
Prioritization of spending on prevention, anti-malarial medicines, and health systems strengthening can fight incident cases and
...
fatalities simultaneously, especially in resource-scarce, malaria-endemic countries. Furthermore, improving the availability, frequency of collection, and quality of detailed disaggregated spending data is essential to support work that strengthens the evidence base on spending efficiency and work that improves understanding of how spending on malaria could be leveraged to bridge gaps in equity across population groups.
more
Global Action Plan on Antimicrobial Resistance
recommended
The goal of the draft global action plan is to ensure, for as long as possible, continuity of successful treatment and prevention of infectious dis
...
eases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.
more
WHO promotes the inclusion of foodborne trematodiases among the targets of preventive chemotherapy interventions. With the aim of providing access
...
to quality medicines, WHO has negotiated with Novartis Pharma AG whereby Novartis donates triclabendazole for the treatment of fascioliasis and paragonimiasis in endemic countries. WHO collects applications from ministries of health and medicines are shipped free of charge.
more
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.
more
Cardiovascular diseases (CVD) represent the highest burden of disease globally. Medicines are a critical intervention used to prevent and treat CVD. This review describes access to medication for CV
...
D from a health system perspective and strategies that have been used to promote access, including providing medicines at lower cost, improving medication supply, ensuring medicine quality, promoting appropriate use, and managing intellectual property issues. Using key evidence in published and gray literature and systematic reviews, we summarize advances in access to cardiovascular medicines using the 5 health system dimensions of access: availability, affordability, accessibility, acceptability, and quality of medicines. There are multiple barriers to access of CVD medicines, particularly in low- and middle-income countries. Low availability of CVD medicines has been reported in public and private healthcare facilities. When patients lack insurance and pay out of pocket to purchase medicines, medicines can be unaffordable. Accessibility and acceptability are low for medicines used in secondary prevention; increasing use is positively related to country income. Fixed-dose combinations have shown a positive effect on adherence and intermediate outcome measures such as blood pressure and cholesterol. We have a new opportunity to improve access to CVD medicines by using strategies such as efficient procurement of low-cost, quality-assured generic medicines, development of fixed-dose combination medicines, and promotion of adherence through insurance schemes that waive copayment for long-term medications. Monitoring progress at all levels, institutional, regional, national, and international, is vital to identifying gaps in access and implementing adequate policies.
more
Despite the considerable improvement in global health, millions of people still lack access to quality health services, including access to effective antimicrobial
...
medicines, or are impoverished as a result of health spending. At the same time, antimicrobial resistance – a consequence of overuse and misuse of antimicrobials – is increasingly a barrier to accessing effective care. The declining effectiveness of antibiotics is driven by multiple factors, many of which can be addressed through well functioning primary health care. However, primary health care has not always had much attention in national health sector responses to
antimicrobial resistance, which often focus on tertiary care, laboratory detection and surveillance. The three pillars of primary health care (community engagement, front-line health services including primary care and essential public health, and multisectoral action on wider health determinants) are central not just to Universal Health Coverage and the Sustainable Development Goals, but also to an effective response to antimicrobial resistance.
more
Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to t
...
he public health system. The primary reason for holding stocks of medicines and medical supplies in a proper scientific manner is to ensure continuous and uninterrupted availability to prevent stock-outs, especially of critical items of supply while at the same time ensuring that stocks of medicines do not get expired. An efficient inventory management is a pre-requisite for optimal stock management. It enables the management of health facilities to know the current pattern of consumption of drug trends over a period of time and also variances. The environmental control of the drugs and other medical supplies play an important role to keep the products' efficacy intact. Some medicines and vaccines need special storage temperature, otherwise, there may be wastage. The quality of the medicines can be adversely affected by poor storage, transportation and distribution. Thus, maintaining proper storage condition for health commodities is vital for ensuring their quality. So, by this training, CDMU wants to educate different people dealing with medicines and equip them for the roles they have to perform efficiently so that the wastage does not take place or can be minimized.
more
Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system
...
of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
more
The World Heart Federation (WHF) Roadmap series covers a large range of cardiovascular conditions. These Roadmaps identify potential roadblocks and their solutions to improve the prevention, detection and management
...
of cardiovascular diseases and provide a generic global framework available for local adaptation. A first Roadmap on raised blood pressure was published in 2015. Since then, advances in hypertension have included the publication of new clinical guidelines (AHA/ACC; ESC; ESH/ISH); the launch of the WHO Global HEARTS Initiative in 2016 and the associated Resolve to Save Lives (RTSL) initiative in 2017; the inclusion of single-pill combinations on the WHO Essential
Medicines’ list as well as various advances in technology, in particular telemedicine and mobile health. Given the substantial benefit accrued from effective interventions in the management of hypertension and their potential for scalability in low and middle-income countries (LMICs), the WHF has now revisited and updated the ‘Roadmap for raised BP’ as ‘Roadmap for hypertension’
by incorporating new developments in science and policy. Even though cost-effective lifestyle and medical interventions to prevent and manage hypertension exist, uptake is still low, particularly in resource-poor areas. This Roadmap examined the roadblocks pertaining to both the demand side (demographic and socio-economic factors, knowledge and beliefs, social relations, norms, and
traditions) and the supply side (health systems resources and processes) along the patient pathway to propose a range of possible solutions to overcoming them. Those include the development of population-wide prevention and control programmes; the implementation of opportunistic screening and of out-of-office blood pressure measurements; the strengthening of primary care and a greater focus on task sharing and team-based care; the delivery of people-centred care and stronger patient and carer education; and the facilitation of adherence to treatment. All of the above are dependent upon the availability and effective distribution of good quality, evidencebased, inexpensive BP-lowering agents.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac
...
ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
This document updates the earlier version published in April 2020. In recent weeks, information on the potential use of chloroquine or hydroxychloroquine for the treatment of people with COVID-19 ha
...
s been disseminated in academic journals and public media. Although there are now ongoing clinical trials testing the efficacy and safety of several medicines for COVID-19, as of the date of this document, there is a lack of quality evidence to demonstrate chloroquine and/or hydroxychloroquine are effective in the treatment of COVID-19. Evidence is recently emerging via small studies with sub-optimal methodologies that are conflicting.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac
...
ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to fac
...
ilitate their appropriate use in Member States;
• provide models to assist Member States in developing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
more
The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines
...
. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priority areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
more
