GDF is the largest global provider of quality-assured tuberculosis (TB)
medicines, diagnostics, and laboratory supplies to the public sector.
Since 2001, GDF has facilitated access to high-...lass="attribute-to-highlight medbox">quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
and delivering more than $200 million worth of diagnostic equipment
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In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and ...hlight medbox">quality-assured medical products. Delegates developed the short Oxford Statement, calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.
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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of esse...ntial medicines and health products that are supplied to countries. The first World Health Assembly in 1948 recognized the need to establish a procurement service at WHO, and recommended setting up an office “to give advice on the procurement of essential drugs, biological products and other medical supplies”.
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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 Preparation...s 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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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor ...e-to-highlight medbox">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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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeter...s, patient monitors, thermometers, infusion and suction pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeter...s, patient monitors, thermometers, infusion and suction pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
more
The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One of those 13 products is the neonatal resuscita...tor, is indispensable medical device to save newborns from asphyxia at birth. For the efficient use of neonatal resuscitation, training of healthcare professionals using neonatal resuscitation manikins is the most effective approach. Critical lifesaving trainings calls for the need of neonatal resuscitation manikins with the right features.
The purpose of the WHO Neonatal resuscitation manikin: technical specifications is to provide a minimum standard baseline to meet the increasing demand to procure good quality, affordable, accessible, and appropriate neonatal resuscitation manikins. Towards the development of this baseline, this document includes compilation of available scientific evidence from technical literature, international publications, expert reviews, and an industry survey which was conducted by WHO medical devices team.
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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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23 February 2021
This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the latest available evidence and interim guidelines. This includes: oxygen therapy, pulse oximeter...s, patient monitors, thermometers, infusion and suction pumps, X-ray, ultrasound and CT scanners as well as personal protective equipment. In order to facilitate access to quality assured priority medical devices, the document also includes technical and performance characteristics, related standards, accessories and consumables. It is intended for policy-makers and planning officers in Ministries of Health, procurement and regulatory agencies, intergovernmental and international agencies as well as the medical device industry.
This document is an update to the List of priority medical devices for COVID-19 case management and Technical specifications for invasive and non-invasive ventilators for COVID-19.
This document complements the Technical specifications of personal protective equipment for COVID-19.
more
Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve ...and maintain a polio free world. However, fragmented approaches and short-term planning pose considerable challenges to securing long-term polio vaccine security.
This framework is designed to enhance the efforts of existing structures and workstreams within the Global Polio Eradication Initiative (GPEI) and other stakeholders by improving communication and coordination on vaccine security. Ensuring vaccine security is crucial for maintaining a timely, sustained, and uninterrupted supply of affordable, quality-assured polio vaccines in the global fight to achieve and sustain a polio-free world. However, challenges such as fragmented approaches, short-term planning, a dynamic policy environment, and a diverse product pipeline present significant risks to long-term vaccine security. This framework emphasizes the need for alignment and coordination across key polio operational domains, including Poliovirus Containment, Research and Development, and Vaccine Manufacturing and Supply. It also underscores the critical role of normative frameworks and policies in shaping long-term vaccine strategies that guide these operational areas. Additionally, it highlights the importance of cross-cutting elements such as financing and access to resources, along with the integration of communication, coordination, and advocacy efforts, as essential enablers for achieving vaccine security. To secure long-term vaccine supply, it is imperative to enhance alignment and strengthen coordinated efforts across workstreams and with stakeholders, including vaccine manufacturers.
Recognizing that vaccine security is an ongoing endeavor, requiring continuous monitoring and adaptation, this framework will undergo regular updates and revisions. Initially, the management of the framework will be carried out by the GPEI Vaccine Supply Group (VSG).
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The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been support...ed by WHO to strengthen their regulatory controls over antimalarial products. The survey was organized independently of manufacturers of antimalarial medicines.
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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 pop...ulation. 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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Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety a...nd efficacy.
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Access to medical personal protective equipment (PPE) is essential for routine healthcare delivery, and a critical tool for containing outbreaks, as well as preventing and responding to pandemics. It is one of our most effective tools against COVID-...19, and an undervalued tool more generally in infection control.
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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 rev...iewed, 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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