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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First edition, November 1997 | Revised July 2002
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
1st edition.
Unitaid’s report describes a slate of new devices that can more efficiently identify dangerously ill children so that they can be treated immediately. These tools make it easier to recognize danger signs, and support integrated approaches to reducing childhood deaths from the three ...greatest childhood killers: malaria, pneumonia and diarrhoea.
The report also highlights tests that can determine whether or not a child has an illness that can be treated with antibiotics. Viral infections are a common cause of childhood fevers, but cannot be cured with antibiotics. Although many children seeking care at clinics have fever, three-quarters by some estimates, only a small fraction of those have an illness that can be treated with an antimalarial or antibiotic drug
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Cancellation of scheduled surgery leads to operating theatre under-occupancy and is recognised as a major cause of emotional trauma to patients and their families. This study aimed to assess the incidence of elective surgery cancellation in order to make proposals for healthcare improvement.
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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This survey is part of a series of eight country surveys conducted in the context of the People that Deliver Initiative (peoplethatdeliver.org). This global initiative, which brings together the world’s largest organizations, aims to improve health services performance through the professionalizat...ion of logistics managers.
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Medicinal plants occupied an important position in the socio-cultural, spiritual and medicinal arena of rural people of India. T
The present report is based on contribution made by members of the task force and many other experts on medicinal plants. We hope the report on implementation will promot...e sustainable and equitable development of medicinal plants sector provide "Health for All", boost exports, and will improve livelihood of the people and green the country for the present and the
generation to come.
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This article examines the activities of national and international actors in Pharmaceutical Services (PS) in Mozambique from 2007 to 2012, focusing on the public provision of HIV/Aids, malaria and tuberculosis medicines. It describes how PS functions in the country, what actors are involved in this ...area and the relations among them, pursuing salient issues in the modus operandi of partners in cooperation.
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This guide helps pharmacists to understand their role in the hypertension program. From maintaining hypertensive drug stock, to drug dispensing, to recording and reporting, to awareness generation with patients.
Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries