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Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
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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-quality TB care in over 130
countries, providing treatments to over 30 million people with TB and procuring
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and delivering more than $200 million worth of diagnostic equipment
more
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 quality, unsafe medic
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ines 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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For full publication see: http://hesperian.org/wp-content/uploads/pdf/sw_hmx/sw_cosmeticrisksinfo_CliffordMajani_2013.docx
Accessed October 2014
This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the
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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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Access to safe, effective and quality-assured health products and technologies is crucial for achieving universal health coverage and primary health care goals. The continued growth of the aging population; increasing burden of noncommunicable disea
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ses; growing burden of mental health issues; climate change; shifting patterns of vector borne diseases, fungal disease and waterborne diseases; antimicrobial resistance; and new infectious hazards create an ongoing need for equitable access to safe, effective and quality-assured health products and technologies, and renewed investments in research and development for innovative health products and technologies.
The coronavirus pandemic exposed the inequalities in access to health products, highlighting the need for longer-term strategies to strengthen access to health products and technologies outside of and in emergency situations. While technological and scientific advances present an opportunity to increase access to health products and technologies, the risk of increasing inequality due to higher prices for new health products and technologies; the persisting problem of substandard and falsified medical products; a lack of skilled workforce in many low- and middle-income countries; and a lack of data for decisionmaking and for measuring progress present significant challenges.
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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 ident
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ify 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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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 essential medicines and health
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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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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to the public health system. The primary reason for hol
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ding 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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August 2020.
In December 2018, the President launched the UHC pilot covering four strategically selected counties-Isiolo, Kisumu, Machakos and Nyeri. It isplanned that by the year 2022, all persons in Kenya will be able to use the essential services they need for their health
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and wellbeing through a single unified benefit package, without the risk of financial catastrophe. Essential health products are considered an integral part of UHC andare an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a review of the UHC pilot in September 2019 established that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for medical supplies was less than 50%for level 2 and 3 facilities and as low as 30%for level 4 and 5 facilities.
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Important Update - Changes to WHOs Prequalification of IVD Assessment Procedure (from 2026)
Starting in 2026, WHO will introduce a new prequalification assessment procedure. The performance evaluation will no longer be part of the prequalification assessment and will become a separate procedure.
R
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apid advances in development of medical devices are generating challenges in quality assurance for manufacturers and regulators, and in both quality assurance and product selection for procurers. Launched in 2010, WHO prequalification of in vitro diagnostics provides a valuable service to each of these groups.
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These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country.
August 2020.
Essential diagnostic products areconsidered an integral part of UHC, they are an indispensable element for delivery ofservices andare also a requirement for qualitycare. Despite this realization, a r
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eview of the UHC pilot in September 2019 established that whereas the Kenya Medical Supplies Authority (KEMSA) was able to fill up to 80% of pharmaceutical items, the order fill rate for diagnostic products was less than 50 percent for level 2 and 3 facilities and as low as 30 percent for level 4 and 5 facilities.
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
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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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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 quality-assured medical
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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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Rwanda’s mountainous topography makes ground transportation of medical supplies unreliable — some roads stretching into rural areas remain uncared for and unpaved. Between 25 and 40 per cent of all temperature-sensitive
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medical supplies sent from urban centres to rural health clinics are wasted because of an unreliable cold-chain infrastructure. Rural clinics are also often subject to stockouts, and patients in need of specialized blood products, drugs and other supplies are unable to acquire them. Zipline, a US-based health logistics company, aims to address the issue of access to medical supplies, largely leapfrogging traditional modes of transportation and various obstacles. Zipline uses drones to deliver blood and other routine and emergency medical supplies from distribution centres to district hospitals and rural health centres.
Although the company has been celebrated in the media for its operations, there is little scholarly work on its operations and performance. This has led to some confusion over its scale. We aimed to gain insight into the details of Zipline’s business model, including the infrastructure, regulations and government support that make Zipline possible, and to understand its impact on health outcomes in Rwanda. Our work was entirely based on published materials since our research was conducted during the COVID-19 pandemic.
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