Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
WHO Model Formulary for children based on the Second Model List of Essential Medicines for Children 2009.
In 2007, the World Health Assembly passed a Resolution titled ‘Better Medicines for Children’. This resolution recognized the need for research and development into medicines for children,... including better dosage forms, better evidence and better information about how to ensure that medicines for treating the common childhood diseases are given at the right dose for children of all ages.
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Second Edition
AIDS Medicines and diagnostics services
July 2015
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
An Act to repeal the Dangerous Medicines Act of 1973,to ensure the availability of certain drugs for exclusive medical, scientific and related purposes, while preventing their abuse; to prevent the diversion from lawful trade of controlled chemicals, controlled equipment and controlled materials for... use in the unlawful manufacture of such drugs; to render drug trafficking and related conduct as serious criminal offences and to ensure that trafficking and related conducted as serious criminal offences and to ensure that offenders or suspects are brought to justice; to render certain conduct by drug users as criminal offences, to provide for the treatment and rehabilitation of drug abusing or dependent offenders; to establish the Lesotho Narcotics Bureau; and for related matters.
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The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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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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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... 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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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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Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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Antimicrobial resistance (AMR) both in human and veterinary medicine has reached alarming levels in
most parts of the world and has now been recognized as a significant emerging threat to global public
health and food security. In June 2015, the Food and Agriculture Organization of the United Nati...ons
(FAO) passed a resolution on AMR at its governing
Conference. This followed the adoption of counterpart
resolutions on AMR by The World Organisation
for Animal Health (OIE) and the World Health Organization
(WHO) in May 20152, and marked the
beginning of a joint effort by the three organizations
to combat AMR globally.
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Antimicrobials are used in veterinary medicine to treat infectious diseases in animals caused or complicated by microorganisms, mainly bacteria, or to prevent the development or spread of infection in healthy animals.
ຢາຕ້ານເຊື້ອຈຸລະຊີບ (Antimicrobial medicines) ມີຄວາມສໍາຄັນຫຼາຍຕໍ່ວຽກງານການແພດ, ສາທາລະນະສຸກ, ສຸຂະພາບສັດ ແລະ ການຜະລິດອາຫານ. ເນ...່ອງຈາກວ່າ ຢາດັ່ງກ່າວນີ້ ແມ່ນໃຊ້ເພື່ອປ້ອງກັນ ແລະ ປິ່ນປົວພະຍາດຊືມເຊື້ອ ທີ່ມີ ຈໍາພວກເຊື້ອຈຸລິນຊີ (Bacteria) ເປັນຫນື່ງໃນສາເຫດທີ່ເຮັດໃຫ້ຄົນ ແລະ ສັດເສຍຊີວິດ ໃຫ້ຫຼຸດລົງໄດ້ ແລະ ມີບົດບາດຫຼາຍໃນວົງ ການແພດແຜນປະຈຸບັນ ເປັນຕົ້ນແມ່ນ ການຜ່າຕັດ ຊຶ່ງມີຄວາມສ່ຽງຕໍ່ການຕິດເຊື້ອໄດ້ງ່າຍຈຶ່ງຈໍາເປັນຕ້ອງໄດ້ເພິ່ງພາຢາຕ້ານເຊື້ອຈຸລະ ຊີບ ທີ່ມີປະສິດທິພາບເພື່ອປ້ອງກັນ ແລະ ປິ່ນປົວການຕິດເຊື້ອທີ່ອາດເກີດຂຶ້ນ. ນອກຈາກນີ້ແລ້ວ ມັນຍັງມີຄວາມຈໍາເປັນສໍາລັບ ປ້ອງກັນ ແລະ ປິ່ນປົວ ໃນວຽກງານສັດຕະວະແພດ ແລະ ການກະສິກໍາ ເປັນຕົ້ນ: ການລ້ຽງສັດ, ການປະມົງ, ການປູກຝັງ ແລະ ມີຄວາມສໍາຄັນຕໍ່ ສຸຂະພາບສັດ ພືດ ຕ່ອງໂສ້ການຜະລິດອາຫານ ແລະ ເສດຖະກິດຂອງຊາດອີກດ້ວຍ.
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities throughout the Organization and encouraging participation in the WHO Programme for International Drug... Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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The global pandemic has highlighted fragility in international supply chains and the dependency of many African countries on imported personal protective equipment (PPE). Market pressures have also increased prices for imported supplies and put additional pressure on areas with limited resources for... procurement. There is an urgent operational need to develop the domestic capacity to supply PPE from within the African continent. There is huge variation in Member
States industrial manufacturing capacity and the regulatory and testing capacity of government agencies at present. Growing number of companies, including micro- and small-medium enterprises, have responded by repurposing, albeit temporarily, to manufacture an assortment of PPEs. This workshop aims to bring together government representatives, industry, and subject matter experts on material testing and standards to promote the development of domestic production of safe and effective PPE made in Africa.
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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 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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Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
Building on our decades of commitment to human rights in medicine and healthcare, we have published a new report on emerging threats in health-related human rights both globally and in the UK.
'Health and human rights in the new world (dis)order' outlines a shifting rights landscape in which new ...technologies, environmental change and geopolitical reconfigurations are putting renewed and at times intense stress on human rights, both in medicine and healthcare more broadly.
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