Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
Ensuring Access to Simple, Safe and Effective First-Line Medicines for Tuberculosis.
Accessed in November 2017.
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 fr...om the wild, they are taken on a basis that is sustainable.
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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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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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 Ins...pection 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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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 of 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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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.
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Antimicrobial resistance (AMR) is a threat to human and animal health and refers to the ability of microorganisms to defy the medicines prescribed. For instance when antibiotics are used improperly, such as an incorrect dose, insufficient duration o...r wrong frequency, resistance is heightened. The misuse of antimicrobials affects their efficacy, and increasingly more infections and diseases become untreatable. Many gains made in modern medicine throughout the 20th century will be lost, making AMR a global public and animal health issue that requires concerted action. AMR and the use of antimicrobials (AMU) affect food safety and security, people’s livelihoods, as well as economic and agricultural development.
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Building on our decades of commitment to human rights in medicine and healthcare, we have published a new report on emerging threats in health-related human rights both globally and in the UK.
'Health and human rights in the new world (dis)order'... outlines a shifting rights landscape in which new technologies, environmental change and geopolitical reconfigurations are putting renewed and at times intense stress on human rights, both in medicine and healthcare more broadly.
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The manual contains basic principles of prescribing followed by chapters on medicines used in psychotic disorders; depressive disorders; bipolar disorders; generalised anxiety and sleep disorders; obsessive-compulsive disorders and panic attacks; an...d alcohol and opioid dependence
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A Joint Position Statement of the Indian Society of Critical Care Medicine (ISCCM) and the Indian
Association of Palliative Care (IAPC)
Indian Journal of Critical Care Medicine September 2014 Vol ...18 Issue 9
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
The management of information and logistics is an essential component of health product systems. In a context of limited financial resources and morbidity and mortality sustained by persistent diseases, it is necessary to strengthen health systems t...hrough competent resources, especially human resources (HR), to ensure performance, sustainability and independence from external funding. In Burkina Faso, a strong and lasting partnership between the Ministry of Health and the Bioforce Institute has existed since 2005 to address this issue. This partnership has created a favorable environment for the professionalization of health logistics and for the recognition of its significant role in health system performance.
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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, the 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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Asthma is a long term illness of the lungs that causes the airways to become inflamed and produce lots of mucus. Viral infections, cold air, allergens, exercise, and smoke make the airways “twitchy”; they close easily causing asthma attacks with... coughing, wheezing and shortness of breath (see what is asthma). Between attacks the airways are inflamed (see what is an allergy).
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This action plan for the Kingdom Saudi Arabia to combat antimicrobial resistance has been formulated in the line of the WHO five objectives. It addresses the need for effective “one health” approach involving coordination among numerous national sectors and actors, including human and veterinary... medicine, agriculture, finance, environment, and well-informed consumers. Therefore, a large committee of all stakeholders was formed with five technical subcommittees were established to addresses every aspect
to contain antimicrobial resistance in the country.
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This World Health Organization (WHO) and the International Labour Organization (ILO) joint guidelines production aims at harnessing the contribution of employers and workers towards the control of TB. It covers all the practical steps involved in es...tablishing TB control activities, including (for large employers) starting and running a workplace TB control programme. They are intended for use in all countries in which TB incidence is high and the target audience for the guidelines includes employers, employee organizations, NTP managers, and agencies providing technical support for TB control.
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The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV ...ht medbox">medicines in developing countries as of April 2014. The focus is primarily on those ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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