Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in t...he African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resistance and lead to loss of confidence in health professionals, manufacturers and distributors and in health systems. In an effort to protect people’s health, the WHO Regional Director for Africa, Dr Matshidiso Moeti, has proposed a strategy aimed at strengthening National Medicine Regulatory Authorities (NMRAs) in order to ensure that only safe, good quality and effective medical products are available.
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Resource platform.
The Global Atlas of medical devices (GAMD) provides global, regional and country data on availability of:
national policy on health technology
...-highlight medbox">regulation of medical devices
health technology assessment national unit
health technology management
use of medical devices nomenclature system
national lists of priority medical devices
high cost medical equipment.
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For the Fiscal Year 2014-2015, the Health Sector continued to implement interventions and strategies meant to improve the availability, accessibility and utilization of quality healthcare services a...cross public and private health facilities; and to ensure the reduction of the burden of communicable and non-communicable diseases in Rwanda. This annual report highlights key achievements registered by the health sector during the Fiscal Year 2014-2015. Achievements are highlighted under three big components: Health Programs, Health Systems Support and Budget Execution.
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability... and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to strengthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State ...tribute-to-highlight medbox">and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enormous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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Interim Guidance, 12 July 2021; This tool was developed to assess present and surge capacities for the treatment of COVID-19 in health facilities. It allows health facilities to assess the availability and... status of stockout of critical COVID-19 medicines, equipment and supplies on site and to identify areas that need further attention to enable the facility to respond effectively to the pandemic. The tool encompasses key components that are essential to managing COVID-19 in a hospital setting, including:
health workforce (numbers, absences, COVID-19 infections, staff vaccinated for COVID-19 health workforce management, training and support);
medicines and medical supplies for management of COVID-19;
IPC capacities (protocols, safety measures, guidelines) and the availability of personal protective equipment (PPE) for staff;
diagnostic testing, imaging and patient monitoring devices and supplies
medical equipment for management of COVID-19, including O2 administration;
COVID-19 vaccine readiness ;
beds and space capacity.
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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability o...r 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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Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and... for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provision, risks associated with inappropriate donations, the responsibilities of donors and recipient, and the steps they should follow before, during and after a donation. It includes three sections: description of major problems that may be faced during the donation process, listing of best practices for donors and recipients and addressing situations requiring special attention. It also has three annexes for further reading: the criteria for the acceptability of a donation, literature review on donations of medical devices between 2010 and 2023 and a flyer. This document is intended to improve the quality of medical devices donations, including medical equipment, single-use medical devices and in-vitro diagnostics, to provide maximum benefit to all stakeholders. The considerations can be used to develop institutional or national policies and regulations for medical devices donations. This document is intended for use by any organization, expert or practitioner involved in the donation, procurement, management of medical devices, including health workers, biomedical engineers, health managers, policymakers, donors, nongovernmental organizations and academic institutions.
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MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATE...D SERVICES | Official Gazette nº 46 of 13/11/2017
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The country profiles incorporate facts indicating the national status of medical devices in areas such as: medical device policies, regulations, incorporation, lists, inventories, nomenclature, he...alth technology assessment, management, and biomedical engineering resources. This publication is intended for use as a reference by decision-makers in Ministries of Health, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional, or global levels.
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Maintaining proper storage conditions for health commodities is vital to ensuring their quality. Product expiration dates are based on ideal storage conditions and protecting ...to-highlight medbox">product quality until their expiration date is important for serving customers and conserving resources. Guidelines for the Storage of Essential Medicines and Other Health Commodities is a practical reference for those managing or involved in setting up a storeroom or warehouse. The guide contains written directions and clear illustrations on receiving and arranging commodities; special storage conditions; tracking commodities; maintaining the quality of the products; constructing and designing a medical store; waste management; and resources. It was written to meet the needs of district-level facilities; however, the guidelines and information it contains apply to any storage facility, of any size, in any type of environment.
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Primary health care offers a cost–effective route to achieving universal health coverage (UHC). However, primary health-care systems are weak in many low- and middle-income countries and<.../span> often fail to provide comprehensive, people-centred, integrated care. We analysed the primary health-care systems in 20 low- and middle-income countries using a semi-grounded approach. Options for strengthening primary health-care systems were identified by thematic content analysis. We found that: (i)despite the growing burden of noncommunicable disease, many low- and middle-income countries lacked funds for preventive services; (ii)community health workers were often under-resourced, poorly supported and lacked training; (iii)out-of-pocket expenditure exceeded 40% of total health expenditure in half the countries studied, which affected equity; and (iv)health insurance schemes were hampered by the fragmentation of public and private systems, underfunding, corruption and poor engagement of informal workers. In 14 countries, the private sector was largely unregulated. Moreover, community engagement in primary health care was weak in countries where services were largely privatized. In some countries, decentralization led to the fragmentation of primary health care. Performance improved when financial incentives were linked to regulation and quality improvement, and community involvement was strong. Policy-making should be supported by adequate resources for primary health-care implementation and government spending on primary health care should be increased by at least 1% of gross domestic product. Devising equity-enhancing financing schemes and improving the accountability of primary health-care management is also needed. Support from primary health-care systems is critical for progress towards UHC in the decade to 2030.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964and...an> play a crucial role in minimizing mortality and morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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Health system resilience is not an inevitable byproduct of any investment in health but must be intentionally programmed and developed with necessary input, investment and contextualization. This te...chnical product aims to guide national, subnational, and global health actors to operationalize the concept of health system resilience for advancement of universal health coverage, health security and ultimately better health for all. It supports the translation of relevant conceptual guidance and high-level recommendations into practical actions.
The specific objectives are to:
present a concise overview of the concept of health system resilience;
provide a roadmap outlining practical and foundational steps for building health system resilience to be adapted to different contexts;
share examples of actions and tools, including stakeholder roles, to support country application of the roadmap.
The target audience for this work is the various stakeholders involved in strengthening health systems and public health including management of emergencies (from prevention and preparedness to response and recovery) and other public health challenges in countries. This ranges from the donors, policy-makers and decision-makers at global, national and subnational levels to the implementing institutions and line managers of health system functions and services across the health system building blocks.
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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 ...an class="attribute-to-highlight medbox">and Registration (MER) of the East African Community Medicine 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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