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.
8th IAS Conference on HIV Pathogenesis 19-22 July 2015 Vancouver
Anita Sands Prequalification Team – Diagnostics Essential Medicines and Health Product
In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems’ ability to prov...ide population-wide access to essential medicines.
Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products.
This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.
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Antimicrobials are used in veterinary medicine to treat infectious diseases in animals caused or complicated by microorganisms, mainly bacteria, or to prevent the development or spread of infection in healthy animals.
The product of all this work is the Standard Treatment Guideline and Essential Medicines List of Common Medical Conditions in the Kingdom of Swaziland. These systematically developed statements are designed to assist practitioners in making decisions about appropriate treatment for specific clinical... conditions. They are meant to reflect expert consensus based on a review of current and published scientific evidence of acceptable approaches to diagnosis, man-agement, or prevention of specific conditions.It is enlightening to note that section A of the document contains the STG, and effort has been made to have the conditions commonly encountered in Swaziland classified according to systems. Written in simple, clear language, each section consists of a short definition followed by common symptoms and signs of the disease or condition and then management (pharmacological and nonpharmacological)
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The PQS on-line catalogue includes details of all immunization-related products currently pre-qualified by WHO for procurement by United Nations agencies. The catalogue is produced and maintained by the Quality, Safety and Standards group in the Immunization, Vaccine and Biologicals Department of WH...O, Geneva. It replaces the old WHO/UNICEF Product Information Sheets (PIS), the last edition of which was published in 2000. Only products included in the PQS catalogue are now recommended to be purchased by UN agencies.
Large File: 120 MB
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Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPC published here describes the characteristics of new types of insecticide-treated nets (ITNs) to control malaria transmission in areas with insecticide-resist...ant mosquito populations. The document was developed to address the public health need caused by the evolution and spread of insecticide resistance, particularly to pyrethroids. Such resistance threatens the effectiveness of the current standard of malaria vector control in many countries, namely pyrethroid-only long-lasting insecticidal nets (LLINs).
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“Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. Some of the vector control interventions deployed in complex emergencies and in response to natural disasters – namely insecticide-treated nets (ITNs) and indoo...r residual spraying (IRS) – have already met identified public health needs in more stable settings; other tools such as insecticide-treated tarpaulins have been specifically designed for this use case. Given the diverse mix of existing and potential new interventions and the considerable gaps in the associated evidence base, this PPC aims to clearly articulate the unmet public health needs for tools designed to control malaria transmission in complex emergencies and in response to natural disasters.
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August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 es...tablished that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
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The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One of those 13 products is the neonatal resuscitator, is indispensable medical device to save newborns from asphyxia at birth. For the efficient use of... neonatal resuscitation, training of healthcare professionals using neonatal resuscitation manikins is the most effective approach. Critical lifesaving trainings calls for the need of neonatal resuscitation manikins with the right features.
The purpose of the WHO Neonatal resuscitation manikin: technical specifications is to provide a minimum standard baseline to meet the increasing demand to procure good quality, affordable, accessible, and appropriate neonatal resuscitation manikins. Towards the development of this baseline, this document includes compilation of available scientific evidence from technical literature, international publications, expert reviews, and an industry survey which was conducted by WHO medical devices team.
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
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The report notes that the number of people in need of one or more assistive products is likely to rise to 3.5 billion by 2050, due to populations ageing and the prevalence of noncommunicable diseases rising across the world. The report also highlights the vast gap in access between low- and high-inc...ome countries. An analysis of 35 countries reveals that access varies from 3% in poorer nations to 90% in wealthy countries.
Affordability is a major barrier to access, the report notes. Around two thirds of people with assistive products reported out-of-pocket payments for them. Others reported relying on family and friends to financially support their needs.
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The GEHM series is an evidence-informed normative product of the WHO
Health and Migration Programme to inform policy-makers on migrationrelated public health priorities. These reviews aim to respond to policy questions identified as priorities by summarizing the best available evidence worldwide an...d proposing policy considerations. By addressing data gaps on the health status of refugees and migrants, the GEHM series aims to support evidenceinformed policy-making and targeted interventions that are impactful and make a difference in the lives of these populations.
This Report, the fourth in the GEHM series reviews the available evidence on barriers to antibiotic access and appropriate use in refugees and migrants. It finds that the available evidence on refugees’ and migrants’ access to and use of antibiotics is scarce and is largely constrained to high-income contexts.
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The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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Background: Donor countries in the Middle East and North Africa (MENA) including Saudi Arabia, Kuwait and United Arab Emirates (UAE) have been among the largest donors in the world. However, little is known about their contributions for health. In this study, we addressed this gap by estimating the ...amount of development assistance for health (DAH) contributed by MENA country donors from 2000 to 2017. Methods: We tracked DAH provided and received by the MENA region leveraging publicly available development assistance data in the Development Assistance Committee (DAC) database of the Organisation for Economic Cooperation and Development (OECD), government agency reports and financial statements from key international development agencies. We generated estimates of DAH provided by the three largest donor countries in the MENA region (UAE, Kuwait, Saudi Arabia) and compared contributions to their relative gross domestic product (GDP) and government spending; We captured DAH contributions by other MENA country governments (Egypt, Iran, Qatar, Turkey, etc.) disbursed through multilateral agencies. Additionally, we compared DAH contributed from and provided to the MENA region.
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Introduction
In 2017, development assistance for health (DAH) comprised 5.3% of total health spending in lowincome countries. Despite the key role DAH plays in global health-spending, little is known about the characteristics of assistance that may be associated with committed assistance that is a...ctually disbursed. In this analysis, we examine associations between these characteristics and disbursement of committed assistance.
Methods
We extracted data from the Creditor Reporting System of the Organization for Economic Co-operation and Development, Institute for Health Metrics and Evaluation, and the WHO National Health Accounts database. Factors examined were off-budget assistance, administrative assistance, publicly sourced assistance and assistance to health systems strengthening. Recipient-country characteristics examined were perceived level of corruption, civil fragility and gross domestic product per capita (GDPpc). We used linear regression methods for panel of data to assess the proportion of committed aid that was disbursed for a given country-year, for each data source.
Results
Factors that were associated with a higher disbursement rates include off-budget aid (p<0.001), lower administrative expenses (p<0.01), lower perceived corruption in recipient country (p<0.001), lower fragility in recipient country (p<0.05) and higher GDPpc (p<0.05).
Conclusion
Substantial gaps remain between commitments and disbursements. Characteristics of assistance (administrative, publicly sourced) and indicators of government transparency and fragility are also important drivers associated with disbursement of DAH. There remains a continued need for better aid flow reporting standards and clarity around aid types for better measurement of DAH.
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