The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
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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7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat...ion’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
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Please find all relevant guidelines and information in our new Pharmacy Toolbox.
The PHARMACY TOOLBOX is a comprehensive knowledge repository to provide its users with practical, up-to-date information on medicines and good pharmaceutical practices. It collates basic documents on (essential) medici...nes, guidelines, rational use, access, and good quality of medicines. All health workers who prescribe, handle or dispense medicines find an electronic key pharmacy knowledge hub.
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Module 6
Pharmacists
July 2017
Module 6: Pharmacists. This module is for pharmacists and people working in pharmacies. It provides information on the medicines used in PrEP, including on storage conditions. It gives suggestions for how pharmacists and pharmacy staff can monitor PrEP adherence... and support PrEP users to take their medication regularly.
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The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National Health Policy. The pharmacy policy addresses, among... other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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The Ethiopian Food and Drug Administration (EFDA) is mandated, in the proclamation 661/2009, to ensure the safety, quality and efficacy of medicines. To achieve this, the authority has been working on different regulatory activities. The medicine market authorization system is one of the top priorit...y areas that have been implemented. In addition to the dedicated assessors, the authority uses a national drug advisory committee for the assessment and registration of medicines.
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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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Phytochem Rev (2023) 22:1691–1806
Plants have a lot of potential and will continue to contribute feasible, effective medicines and/or pesticides; more research is warranted to fully explore their future applications
Antimicrobial resistance (AMR) threatens the effective prevention and treatment of an ever-increasing range of infections caused by bacteria, parasites, viruses and fungi.
AMR occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines making infections ha...rder to treat and increasing the risk of disease spread, severe illness and death. As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others.
Antimicrobials - including antibiotics, antivirals, antifungals and antiparasitics - are medicines used to prevent and treat infections in humans, animals and plants. Microorganisms that develop antimicrobial resistance are sometimes referred to as “superbugs”.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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Antimicrobial resistance (AMR) is a threat to global health and development and it contributes to millions of deaths worldwide each year. Inappropriate use and overuse of antibiotics are driving an increase in AMR and have a detrimental impact on the effectiveness of these critical medicines. Throug...h the Global Action Plan on AMR, WHO is working to improve the surveillance of antimicrobial resistance and reduce inappropriate antibiotic consumption.
There is a recognized need for high-quality resources to improve antibiotic prescribing globally. To address this need, a pragmatic approach was taken by WHO to develop actionable guidance for empiric antibiotic use.
The WHO AWaRe (Access, Watch, Reserve) antibiotic book provides concise, evidence-based guidance on the choice of antibiotic, dose, route of administration, and duration of treatment for more than 30 of the most common clinical infections in children and adults in both primary health care and hospital settings. The information included in the book supports the recommendations for antibiotics listed on the WHO Model Lists of Essential Medicines and Essential Medicines Children and the WHO AWaRe classification of antibiotics.
The WHO AWaRe antibiotic book is accompanied by summary infographics for each infection for both adults and children that provide a quick-reference guide for health care workers at the point of care.
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Усиление мер реагирования системздравоохранения на COVID-19: техническое руководство № 3: поставки основныхлекарственных препаратов и медицинских приборов, 6 апреля ...2020 г
Strengthening the health systems response to COVID-19: technical guidance #3: supply of essential medicines and health technologies, 6 April 2020
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This book is a practical manual of mental health care for community health workers, primary care nurses, social workers and primary care doctors, particularly in developing countries.Helpful features include: over 50 illustrations and case studies, jargon-free explanations and descriptions, flow-cha...rts on common clinical problems, and a practical guide to the use of psychiatric medicines and simple psychological treatments.
Chapters 1, 9 and 10 can be found on the e-TALC CD-ROM number 2 (April 2003). See www.talcuk.org for details Links to Chapters 2 and 3 above. Printed copies of this book can also be obtained from the Royal College of Psychiatrists www.rcpsych.ac.uk/wnitp
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9 June 2021
Since its launch, GLASS has expanded in scope and coverage and as of May 2021, 109 countries and territories worldwide have enrolled in GLASS. A key new component in GLASS is the inclusion of antimicrobial consumption (AMC) surveillance at the national level highlighted in this fourth G...LASS report.
The fourth GLASS report summarizes the 2019 data reported to WHO in 2020. It includes data on AMC surveillance from 15 countries and AMR data on 3 106 602 laboratory-confirmed infections reported by 24 803 surveillance sites in 70 countries, compared to the 507 923 infections and 729 surveillance sites reporting to the first data call in 2017.
The report also describes developments over the past years of GLASS and other AMR surveillance programmes led by WHO, including resistance to anti-human immunodeficiency virus and anti-tuberculosis medicines, antimalarial drug efficacy.
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The publication of the of the Antimicrobial Treatment Guidelines represents the
culmination of the efforts of the Antimicrobial Stewardship Program of ICMR to publish treatment guidelines for common syndromes in India. These guidelines are targeted for the health care settings. It aims to rationali...ze the usage of antibiotics on our Essential Medicines Formulary (EMF) and to establish consistency in the treatment of various infectious conditions.
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As we approach World Asthma Day on the May 2, 2023, we reflect on the theme “ Asthma Care for All”. Prevalence of Asthma is increasing amongst children, adolescents and adults. Under-diagnosis, underutilization of inhaled corticosteroids, inaccessibility of treatment, and unaffordability of medi...cines are amongst the challenges that low-middle income countries are faced with. This commentary seeks to highlight the challenges, the resources available and to suggest recommendations that can be implemented to improve asthma care for all and reduce burden of asthma in Africa.
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An estimated 59 000 people die from rabies each year. That’s one person every nine minutes of every day, 40% of whom are children living in Asia and Africa. As dog bites cause almost all human cases, we can prevent rabies deaths by increasing awareness, vaccinating dogs to prevent the disease at i...ts source and administering life-saving treatment after people have been bitten. We have the vaccines, medicines, tools and technologies to prevent people from dying from dog-mediated rabies. For a relatively low cost it is possible to break the disease cycle and save lives
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The Access to Controlled Medications Programme identified the development of treatment guidelines that cover the treatment of all types of pain as one of the core areas of focus for improving access to opioid analgesics. Such guidelines are interesting both for health-care professionals and policy-...makers. They are also important in improving access to controlled medicines for determining when those opioid medicines and when non-opioid medicines are preferred.
Based on a Delphi study, WHO planned the development of three treatment guidelines, covering chronic pain in children, chronic pain in adults and acute pain.
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This policy brief has been developed in response to the contemporary challenge of antibiotic resistance (ABR). ABR poses a formidable threat to global health and sustainable development. It is now increasingly recognized that the systematic neglect of cultural factors is one of the biggest obs...tacles to achieving better health outcomes and better standards of living worldwide. Using a cultural contexts of health approach, the policy brief explores the centrality of culture to the challenge of ABR. The brief examines how the prescription and use of antibacterial medicines, the transmission of resistance, and the regulation and funding of research are influenced by cultural, social and commercial, as well as biological and technological factors. The brief moves beyond the ready equation of culture with individual behaviours and demonstrates how culture serve as an enabler of health and provide new possibilities for change.
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