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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The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes 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.
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This document provides a generic model that can be used for risk assessment of exposure to insecticide products applied as indoor residual sprays. It aims to harmonize the risk assessment of such insecticides for public health use in order to generate comparable data for their registering and labell...ing by national regulatory authorities. The assessment considers both adults and children (all age groups) as well as people in the following specific categories:
- those preparing the spray;
- those applying the spray;
- residents living in the treated houses;
- residents who participate in preparing and applying insecticides.
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This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field
application rates of new molluscicide products for control of schistosomiasis.
A discussion paper outlining the first steps in developing a nutrient profile model to drive changes to product composition and labelling and promotion practices in the WHO European Region
The aims of the guidance are to protect breastfeeding, prevent obesity and chronic diseases, promote a healthy... diet, and ensure caregivers receive clear and accurate information on infant and young child feeding.
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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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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 chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
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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 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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Self-care interventions are evidence-based, quality drugs, devices, diagnostics and/or digital products which can be provided fully or partially outside of formal health services and can be used with or without the direct supervision of health care personnel.
Where HPV tests are available as part o...f the national programme, HPV self-sampling offers an additional option to improve cervical cancer screening coverage.
Self-sampling can help reach a global target of 70% coverage of screening by 2030. Women may feel more comfortable taking their own samples, rather than going to see a health worker for cervical cancer screening.
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Food inspection is crucial for ensuring food safety, using risk-based approaches to target high-risk products and businesses. This guidance aids national authorities in designing and implementing risk-based systems, offering step-by-step instructions, examples, and tools for prioritization and inspe...ction frequency estimation. It emphasizes adapting to individual country needs and recognizing variations in food risks and production chain characteristics. The document underscores resource-efficient, risk-based food inspection systems, prioritizing high-risk products and businesses to prevent safety incidents proactively. It suggests designing models based on relevant information and periodically adjusting them for continuous improvement.
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Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
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Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncom...municable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
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For thousands of years, humans have been using wildlife for commercial and subsistence purposes. Wildlife trade takes place at local, national and international levels, with different forms of wildlife, such as live animals, partly processed products and finished products. Wildlife is a vital source... of safe and nutritious food, clothing, medicine, and other products, in addition to having religious and cultural value. Wildlife trade also contributes to livelihoods, income generation and overall economic development.
However, wildlife trade can have detrimental effects on species conservation, depleting natural resources, impoverishing biodiversity and degrading ecosystems (Morton et al., 2021). Wildlife trade, whether legal or illegal, regulated or unregulated, can pose threats to animal health and welfare. It also presents opportunities for zoonotic pathogens to spill over between wildlife and domestic animals, and for diseases to emerge with serious consequences for public or animal health and profound economic impacts (IPBES, 2020; Swift et al., 2007; Smith et al., 2009; Gortazar et al., 2014; Stephen, 2021; Stephen et al., 2022; FAO, 2020). The risk of pathogen spillover and disease emergence is amplified with increased interaction between humans, wildlife and domestic animals. The risk of pathogen spillover has also been exacerbated by climate change, intensified agriculture and livestock production, deforestation, and other land-use changes. Wildlife trade is also a risk to ecosystem biodiversity via the introduction of invasive species (Wikramanayake et al., 2021). Therefore, increased effort must be put into understanding the potential consequences of the wildlife trade, mapping and analysing the adjacent risks, and implementing strategies to manage those risks. Reducing wildlife-trade risks not only helps to limit disease but also minimises the negative effects of invasive species. Between 1960 and 2021, invasive alien species caused estimated cumulative damage of around 116 billion euros across 39 countries in the European Union alone, despite strict import regulations (Haubrock et al., 2021). The effect of invasive species is extremely apparent.
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