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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On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
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2nd edition. A Guide to Managing Medicines for All Health Workers. Available for purchase via following link https://www.twn.my/title2/books/HAI.htm
Where there are no trained pharmacists serving communities, other categories of health workers are called upon to order, buy, store, dispense and ad...vise people on rational use of medicines. Where There Are No Pharmacists explains how to order them, store them, prepare them, dispense them and use them safely and effectively - it is about managing medicines. Information to help communities benefit from the use of medicines is also included.
This book walks readers through each step, covering topics ranging from policy issues to patient education. It provides guidance for anyone who is doing the work of a pharmacist; anyone who sells, dispenses, prepares, manages, or explains to others how to use 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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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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Using an inhaler is the most common and effective way of taking asthma medicines. If you’re NOT using your inhaler correctly, you might not be getting the full dose of medicine your doctor or asthma nurse prescribed because the medicine can’t reach your
lungs. Instead it might be hitting the ba...ck of your throat, orstaying on your tongue or in your mouth where it won’t help atall.
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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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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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Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.
DOI 10.15252/emmm.201404792 |Published online 30.12.2014
EMBO Molecular Medicine(2014)emmm.201404792
DOI:https://doi.org/10.1016/S2213-2600(20)30316-7
The Lancet Respiratory Medicine
Rabies is entirely preventable, and vaccines, medicines, tools and technologies have long
been available to prevent people from dying of dog-mediated rabies. Nevertheless, rabies still
kills about 60 000 people a year, of whom over 40% are children under 15, mainly in rural areas
of economically ...disadvantaged countries in Africa and Asia. Of all human cases, up to 99% are
acquired from the bite of an infected dog.
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Exciting new treatment approaches make the management of hepatitic C one of the most rapidly developing areas of medicine. The Flying Publisher short Guide to Hepatitis C is an up-to-date source of information for physicians, residents and advanced medical students.
Tis 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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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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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 or wrong frequency, resistance is heightened. The mi...suse 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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For several years, agencies supporting preparedness and response to cholera outbreaks have supplied medicines and medical devices through the Interagency Diarrhoeal Disease Kits (IDDK).
In an effort to better align the presentation and content of the kits to field needs, the composition of the ch...olera kits has been reviewed by WHO and its partners in 2015 and again in 2020. The content of all modules have been slightly revised with no changes except for the cholera laboratory check list.
The revised cholera kits 2020 are designed to help prepare for a potential cholera outbreak and to support the first month of the initial response for 100 cases. The overall package consists of six different kits, each divided in several modules.
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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 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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14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man...ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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