An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
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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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
MICROBIAL DRUG RESISTANCEVolume 24, Number 5, 2018ªMary Ann Liebert, Inc.DOI: 10.1089/mdr.2017.0383
Antibiotic resistance (ABR) is a worldwide publichealth concern, with serious health, economic, and so-cietal repercussions. Its emergence is attributed to the se-lective pressure exerted by antib...iotic use in the community, hospitals, veterinary health, agriculture, aquaculture, and the environment. Additionally aggravating the situation is the fact that very few new antibiotics have recently been produced by pharmaceutical companies. It is widely acknowledged that food animals are key reservoirs of antibiotic-resistant bacteria and that antibiotic usage in this population favors the emergence, selection, and spread of resistance among animals and humans, both through zoonoses (infectious diseases trans-mitted between animals and humans) and the food chain.
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FEY ENFOMASYON POU MOUN K’AP RESEVWA AVEK MOUN K’AP BAY SWEN OTORIZASYON POU ITILIZASYON IJANS (EUA) POU VAKSIN MODERNA COVID-19 POU ANPECHE CORONAVIRUSDISEASE 2019
(COVID-19) NAN PERSONN 18 ANE AK PI GRAN
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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Three Years After Enactment of the Drug Quality and Security Act
This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its objectives are to minimize... the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance.
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This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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This paper focuses on the Sustainable Development Goals related to poverty, economic growth, inequality, health, food production and the environment. It presents concrete examples of the underlying and complex aspects of antibiotic resistance and its impacts across different Sustainable Development ...Goals. The aim of this paper is to inform and stimulate discussions on how to further advance the implementation of 2030 Agenda for Sustainable Development, the Global Action Plan on Antimicrobial Resistance, National Action plans on Antimicrobial Resistance, as well as work within all sectors that affect and are affected by antibiotic resistance
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FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them. Here you can find informations to laws &policies, compliance action, ....
Version: 14 March 2019; A one-page reference guide to all the anti-HIV drugs licensed for use in the European Union, with information on formulation, dosing, key side-effects and food restrictions.
The previous edition of the drugs chart is also available to download in Russian.
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 volume contains monographs prepared at the ninety-first meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met virtually online from 1 to 12 February 2021.
The detailed monographs in this volume summarize data on specific contaminants in food. Individual monographs ...present the assessment of exposure to cadmium from all food sources, the technical, analytical, dietary exposure and toxicological data on ergot alkaloids, an assessment of five substances that may occur as previous cargoes, and a revision of the specifications for steviol glycosides. This volume and others in the WHO Food Additives series contain information that is useful to those who produce and use food additives and veterinary drugs and those involved with controlling contaminants in food, government and food regulatory officers, industrial testing laboratories, toxicological laboratories and universities.
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Antimicrobials are widely used in food animal production, and use is rapidly increasing.
In an era of growing demand for animal products, there is an increasing trend towards the industrial production of food animals, especially in lower- and middle-income countries (LMICs). One hallmark of this me...thod of animal production is the
use of antimicrobial drugs, which in the majority of cases are administered to healthy animals for purposes other than
treating or controlling disease (termed “therapeutic uses”)
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Indian markets caused a stir across the country.1
According to the Centre for Science and the Environment (CSE), a respected New Delhi-based NGO, most honey brands
sold in India contained varying amounts of antibiotics. Their consumption over time could induce resistance to antibiotics,
putting p...eople at risk of treatment failure in case of severe infections.
For the study, 12 samples were picked in Delhi, all well-known brands, including one each from Australia and Switzerland.
Antibiotics found included Chloramphenicol and various broad-spectrum drugs such as Ciprofloxacin and Erythromycin.
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