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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This report explores the reasons why global health is critical to medicine and what this means for medical education. It argues that an understanding of global health is important for all students and practicing doctors, rather than being an ‘add-on’ or ‘option’ for specialization.
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
The publication of the Second Edition of the Emergency Drug Guidelines represents the culmination of the efforts of the National Drugs and Therapeutics Committee (NDTC) to publish clinical drug guidelines for common diseases seen in Fiji. These guidelines are targeted for health care professionals w...orking at hospitals and at the primary health care settings. It sets the gold standard for the use of drugs in the treatment of emergency medical conditions in Fiji. The guidelines have taken into account the drugs available in the Fiji Essential Medicines Formulary (EMF), 2006 Edition, in recommending treatment approaches. All recommended therapies are either evidencebased or universally accepted standards
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The aim of these Guidelines is to provide a framework for the conservation and sustainable use of plants in medicine. To do this, the Guidelines describe the various tasks that should be carried out to ensure that where medicinal plants are taken from the wild, they are taken on a basis that is sust...ainable.
The Guidelines conform to the principles of Caring for the Earth, prepared in partnership by IUCN, UNEP and WWF. Caring for the Earth extends the message and scope of the World Conservation Strategy to an ethic of sustainable living, and explains how to integrate conservation with development. Its message is particularly relevant to the issue of medicinal plants, which in many parts of the world are being seriously depleted due to over-exploitation and loss of habitats, resulting in a lack of essential medicines and so reducing options for the future.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/ Sinopharm, th...e Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorization for the vaccine (see scenario #1) and the specification is 0.5ml/dose, 1 dose/vial; or 2 doses/vial; or 5 doses/vial. As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell ...[Inactivated]) – CoronaVac, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorisation for the vaccine (see scenario #1). As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1
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The Ideal Clinic Realisation and Maintenance (ICRM) programme was initiated by the National Department of Health in July 2013 in order to systematically improve primary health care (PHC) facilities and the quality of care they provide. The Ideal Clinic framework/dashboard sets out the standards for ...PHC facilities to provide good-quality health services. An Ideal Clinic is defined as a clinic with good infrastructure, adequate staff, adequate medicines and supplies, good administrative processes, and sufficient adequate bulk supplies. Applicable clinical policies, protocols and guidelines are adhered to, and it harnesses partner and stakeholder support.
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The recommendations cover the level of blood pressure to start medication, what type of medicine or combination of medicines to use, the target blood pressure level, and how often to have follow-up checks on blood pressure. In addition, the guideline provides the basis for how physicians and other h...ealth workers can contribute to improving hypertension detection and management.
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his first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin for trachoma and yaws; diethylca...rbamazine citrate for lymphatic filariasis; ivermectin for onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases; praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases. Standard operating procedures for diseases amenable to case management will be covered in subsequent editions, including the application process for requesting medicines (Chapter 1). In the meantime, the procedures described in the rest of the document apply for both case management and preventive chemotherapy NTD health products.
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Accessed on 31.03.2023
COUNTDOWN Nigeria has applied a Participatory Action Research (PAR) approach to improve equity of Mass Administration of Medicines (MAM) and inform Neglected Tropical Disease (NTD) policy through an enhanced community engagement strategy. A situational analysis conducted i...n 2016 identified community engagement as a
bottleneck to achieving equitable coverage of MAM within different and emerging contexts (border, migrant, rural and urban) of Nigeria, related to programmatic, social, political and environmental changes over time See: (Dean et al., 2019), (Oluwole et al., 2019) and (Adekeye et al., 2019)
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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The first important change is a new priority ranking of the available medicines for MDR-TB treatment, based on a careful balance between expected benefits and harms. Treatment success for MDR-TB is currently low in many countries. This could be increased by improving access to the highest-ranked med...icines for all patients with MDR-TB.
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As a public good, antimicrobial medicines require rational use if their effectiveness is to be preserved. However, up to 50% of antibiotic use is inappropriate, adding considerable costs to patient care, and increasing morbidity and mortality. In addition, there is compelling evidence that antimicro...bial resistance is driven by the volume of antimicrobial agents used. High rates of antimicrobial resistance to common treatments are currently reported all over the world, both in health care settings and in the community. For over two decades, the Region of the Americas has been a pioneer in confronting antimicrobial resistance from a public health perspective. However, those efforts need to be stepped up if we are to have an impact on antimicrobial resistance and want to quantify said impact.
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Pakistan Global Antibiotic Resistance Partnership (GARP) was formed in the wake of international and national efforts for AMR curtailment. A group of experts from microbiology, infectious diseases and veterinary medicine formed a core group at the organizational meet...ing of GARP in Kathmandu, Nepal in July 2016. In the meeting, this core group was expanded to include other members from different sectors with the selection of the Chair and co-chairs. These were asked to serve on a voluntary basis, in their own individual capacities, with no personal gains, or gains to the institutions to which they are affiliated. The first phase of GARP took place from 2009 to 2011 and involved four countries: India, Kenya, South Africa and Vietnam. Phase one culminated in the 1st Global Forum on Bacterial Infections, held in October 2011 in New Delhi, India. In 2012, phase two of GARP was initiated with the addition of working groups in Mozambique, Tanzania, Nepal and Uganda. Phase three has added Bangladesh, Lao PDR, Nigeria, Pakistan and Zimbabwe to the network to date.
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The Transatlantic Task Force on Antimicrobial Resistance (TATFAR) fosters cooperation between the European Union (EU) andthe United States (US) on the issue of antimicrobial resistance. The first TATFAR recommendation refers to appropriate use of antimicrobials in human medicine through hospital Ant...imicrobial Stewardship Programs (ASPs) and, specifically, to the development of common structure and process indicators of ASP. These indicators should allow characterization of programs and comparisons among healthcare systems in EU and US.
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DOI 10.15252/emmm.201404792 |Published online 30.12.2014
EMBO Molecular Medicine(2014)emmm.201404792
Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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