• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate 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.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate 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 facilitate 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 facilitate 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
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
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The goal of the draft global action plan is to ensure, for as long as possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.
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 the 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.
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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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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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Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine | The aim of this study was to explore the risk factors for stillbirth and neonatal death and change in perinatal outcomes after the introduction of helping Babies Breathe Quality Improvement Cycle in Nepal.
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 a...nd 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.
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Oxygen is an essential medicine required at all levels of the health care system; only high quality, medical-grade oxygen should be given to patients. Pressure swing adsorption (PSA) oxygen generating plants are a source of medical-grade oxygen. This document provides technical specifications as th...e minimum requirements that a PSA Oxygen Plant must meet for use for the administration of medical-grade oxygen.
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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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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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GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 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
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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 paragonim...iasis in endemic countries. WHO collects applications from ministries of health and medicines are shipped free of charge.
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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 CVD from a health system perspective and strategies that have been used to promote access, including pro...viding 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.
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