Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically
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assist national medicines regulatory authorities to understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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The pharmaceutical sector of any nation is responsible for providing society with quality medicines and other pharmaceutical services. According to the World Health Organization (WHO), Pharmaceutica
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ls may constitute as much as 40% of the national health budget in developing countries, yet portions of the population may lack access to the most essential medicines; while the limited funds available for health are spent on unnecessary, ineffective and even dangerous medications.
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2016 ASCO EDUCATIONAL BOOK | asco.org/edbo
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
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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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The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National
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Health Policy. The pharmacy policy addresses, among other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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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
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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 occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information
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on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials
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to treat serious bacterial and fungal infections.
The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.
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WHO Annual Meeting with Pharmaceutical Companies and Stakeholders
08 March 2016, Geneva
2015-06-03 - Board presentation - v32.pptx
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
This guide can inform any partner that manages or supports public health supply chains. Ministries of health, technical assistance partners, or non-governmental organization (NGO) operating distribution systems can all benefit from conducting a costing exercise and can use the material presented in
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this guide to support their efforts.This guide serves as a companion to the project’s manual for the Supply Chain Costing Tool (SCCT), an Excel-based software application that supports supply chain costing analysis efforts. However, this guide presents a methodology that does not assume use of any particular costing.
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The 6th edition of the essential medicine list has been developed based on the 5th edition list of essential medicines, the National Standard Treatment Guidelines and Protocols 2013, list of laboratory commodities and List of Consumables used in public health facilities.