Guide for coordinators and data collectors - The WHO Operational Package for Assessing, Monitoring and Evaluating Country Pharmaceutical Situations is intended as a useful tool for researchers, policy-makers, planners and others who need to use standardized measurement tools to gather data and other... information. In addition, the operational package can be used by international agencies and donors, by professional groups and nongovernmental organizations (NGOs).
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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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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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These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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Antimicrobial agents play an indispensable role in animal health and welfare management. At the same time, the need for prudent use is obvious to ensure good food safety outcomes and to manage the potential risk of antimicrobial resistance. The emergence of multi-resistant bacteria is posing challen...ges to health professionals and communities around the world for both human and animal health. These bacteria are not destroyed by the common antimicrobial agents and so pose a risk to people, particularly children, the elderly and those with poorly functioning immune systems, as well as to animals.
Throughout the years, the dairy sector has been very much aware of the need for responsible use and has, in many countries, implemented adequate measures throughout the dairy supply chain.
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In 1998 the Swedish Veterinary Association decided to adopt a general policy for the use of antibiotics in animals. Since then specifi c policies for the use of antibiotics in dogs and cats have been adopted and in 2011 Guidelines for the use of Antibiotics in Production animals – Cattle and Pigs,... were accepted. By decision of the board of the Swedish Veterinary Society (SVS) these guidelines have been updated. Th e over-arching goal of SVS is to achieve a low and controlled use of antibiotics in Swedish animal production so that the fi rst-hand choices of treatment remain effi cient and that the spread of antimicrobial resistance – among animals and herds as well as in the food chain – is kept at a minimum. Keeping antimicrobial resistance in animals low is important also for human health, since we are all part of the same ecosystem. Th e authors of these guidelines hope that they may be useful for veteri-narians in clinical practice when deciding on treatments for common diseases and ailments caused by bacteria. Sometimes the decision may even be to refrain from use of antibiotics and chose other ways of improving herd health.
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2014-2020, Draft March 2014
Indian markets caused a stir across the country.1
According to the Centre for Science and the Environment (CSE), a respected New Delhi-based NGO, most honey brands
sold in India contained varying amounts of antibiotics. Their consumption over time could induce resistance to antibiotics,
putting p...eople at risk of treatment failure in case of severe infections.
For the study, 12 samples were picked in Delhi, all well-known brands, including one each from Australia and Switzerland.
Antibiotics found included Chloramphenicol and various broad-spectrum drugs such as Ciprofloxacin and Erythromycin.
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