Laboratory Biossafety Manual
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
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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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Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide f
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or the functions and powers of the Authority; provide for the registration and regulation of pharmacies, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines
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and Health Products Price and Availability Monitoring Mobile Application. This tool facilitates rapid and inexpensive data collection at the facility level.
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This Rapid Advice Guideline updates the Interim Guidance on the “Assessment of infants with microcephaly in the context of Zika virus” published in February 2016 (WHO/ZIKV/MOC/16.3). The recommendations provides guidance on the screening, clinical assessment, neuroimaging, laboratory investigati
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on and follow-up of children born to women living in areas of Zika virus transmission. The Guideline summarises the evidence base and rationale in support of the recommendations and expands the scope to address complications beyond microcephaly and what is now referred to as the congenital Zika virus syndrome
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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
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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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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
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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 recommendations in this guideline are intended to inform development of national and subnational health policies, clinical protocols and programmatic guides. The target audience includes nationa
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l and subnational public health policy-makers, implementers and managers of maternal, newborn and child health programmes, health-care facility managers, supervisors/instructors for in-service training, health workers (including midwives, auxiliary nurse-midwives, nurses, paediatricians, neonatologists, general medical practitioners and community health workers), nongovernmental organizations, professional societies involved in the planning and management of maternal, newborn and child health services, academic staff involved in research and in the pre-service education and training of health workers, and those involved in the education of parents.
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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical pr
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actice, thus help to achieve the ultimate goal to make safer and more effective treatment available to patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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The Kenya Essential Medicines List 2019 is an indispensable guide to the medicines recommended for the management of common conditions in Kenya. It is primarily directed at health care providers and
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medicines supply managers in the public and non-public health sectors. It should be used together with the current versions of updated national clinical guidelines for those conditions for which such guidelines exist
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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 f
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ocusing 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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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV‑2) causing coronavirus disease 2019 (COVID-19) has reached pandemic levels;
Patients with cardiovascular (CV) risk factors and established cardiovascular disease (CVD) represent a vulnerab
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le population when suffering from COVID-19;
Patients with cardiac injury in the context of COVID-19 have an increased risk of morbidity and mortality
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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
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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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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
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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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This CPD Policy relates to all health professionals in the four Health Professional Councils in Rwanda namely; RMDC, NCNM, RAHPC, and RPC. The policy requires all health professionals to participate in the CPD Programs. The purpose of this CPD Polic
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y is to support the professionals in the respective councils to develop a culture of continuing learning, acquire new knowledge and skills, and ensure efficient regulation and appropriate delivery of healthcare services to the community.
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