Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
The growing challenges for people in low and middle-income countries to access new medicines.
Analysis 58
2nd edition - Published in 2003, the first WHO/HAI medicine prices manual Medicine Prices – A
New Approach to Measurement Draft for field-testing provides a draft methodology and tools to conduct national medicine prices and availability surveys. This second edition of the survey manual has been... updated to reflect the wealth of practical
experience in conducting medicine prices and availability surveys garnered in the project’s first two phases.
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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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Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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First edition, November 1997 | Revised July 2002
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for... the first two to five products to become available in about 10 years.
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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...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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The Antimicrobial Resistance Benchmark has evaluated for the second time how the most important players in the antibiotic market are addressing the rise of resistance and the global need for appropriate access to antibiotics. Although we can see progress — it’s hanging by a thread.
We have reac...hed a tipping point where large and prominent drugmakers have retreated from the antibiotics field and smaller innovative biotech companies have gone bankrupt due to the poor financial rewards on offer.
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This joint ECDC-European Union Aviation Safety Agency (EASA) document aims to support Member States in determining a coordinated approach to reduce the risks related to the movement of people by air within and between the EU/EEA countries and the UK in the context of the COVID-19 pandemic, noting th...at the impact of quarantine and testing is likely to vary according to levels of ongoing community transmission, and in the context of ECDC’s current advice that non-essential travel should be avoided during the end-of year festive period
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Health Evidence Network synthesis report 72
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Access to controlled medicines. 3rd edition
22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi...ve role in restricting fair access to a life-saving health product. This report focuses on six leading vaccine developers, AstraZeneca, BioNTech, Johnson & Johnson, Moderna, Novavax and Pfizer, assessing each company’s human rights policy, pricing structure, records on intellectual property, knowledge and technology sharing, allocation of available vaccine doses and transparency.
Available in Arabic, English, French, German and Spanish
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This second edition of the Infection prevention and control in the context of coronavirus disease (COVID-19): A living guideline provides the most up to date technical guidance on mask use in community settings in the context of COVID-19.
In this edition, new information includes updated mask re...commendations for children in community settings including updated age specific recommendations, statements for children with disabilities and those at high risk for complications related to COVID-19 infection. Updated implementation considerations for mask use in school settings are also included.
This living guideline is being published using the MAGICApp online publishing platform https://app.magicapp.org/#/guideline/Lr2a8L , as well as in PDF copy on the WHO website.
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