Submitted to the US Agency for International Development by the
Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program.
This manual provides a framework to identify problems and design interventions to improve access to and use of medicines for children. It is a resource for ...both health policy makers and health system managers and presents a structured approach to the steps introduced in the framework in the context of child health.
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To understand the national situation, Ethiopia did a situation assessment, launched its first strategy in 2011, and took action to contain AMR, as detailed in the blue boxes found throughout this strategy. This updated version of the strategy was in response to the revised health and medicines polic...ies, health sector transformation plan, and the resolutions of the 68th World Health Assembly
of May 2015 and so that Ethiopia’s efforts could be coordinated with global initiatives in the prevention and containment of AMR.
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Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
Pharmaceutical News
Evaluation of Saccharide Content of the WHO 2nd International Standard for Haemophilus Influenzae Polysaccharide Polyribosyl Ribitol Phosphate (PRP) by HPAECPAD Analysis Following Acid Hydrolysis
Consultation Documents
Lamivudine and tenofovir disoproxil fumarate tablets (lami...vudini et tenofoviri disoproxili fumarati compressi)
Tenofovir disoproxil fumarate tablets (tenofoviri disoproxili fumarati compressi)
ATC/DDD Classification
Temporary
Final
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DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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This document is a guide for national authorities who are responsible for managing public health responses to COVID-19
Millennium Development Goal 8E aims for affordable access to essential medicines. Essential medicines, as defined by WHO, are those that “satisfy the health-care needs of the majority of the population” and that should therefore “be available at all times in adequate amounts”. However, there... is a category of medicines that faces a unique challenge in terms of availability. These are the medicines governed by the international conventions on narcotic and psychotropic substances. “Controlled medicines” is the common definition for pharmaceuticals whose active principles are listed under the 1961 United Nations Single Convention on Narcotic Drugs as amended by the 1972 Protocol, such as morphine and methadone; the 1971 United Nations Convention on Psychotropic Substances, such as diazepam and buprenorphine; and the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, such as ergometrine and ephedrine. The conventions list substances in “Schedules” according to their different levels of potential for abuse and harm, and the commensurate severity of control measures to be applied by countries.
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Interim Guidance 7 March 2020
This document provides technical guidance for government authorities, health workers, and other key stakeholders to guide response to community spread. It will be updated as new information or technical guidance become available. For countries that are already preparin...g or responding, this document can also serve as a checklist to identify any remaining gaps.
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The intent of these guidelines is to develop a holistic, coordinated, proactive and technology driven strategy for management of biological disasters through a culture of prevention, mitigation and preparedness to generate a prompt and effective response in the event of an emergency. Th...e document contains comprehensive guidelines for preparedness activities, biosafety and biosecurity measures, capacity development, specialised health care and laboratory facilities, strengthening of the existing legislative/
regulatory framework, mental health support, response, rehabilitation and recovery, etc. It specifically lays down the approach for implementation of the guidelines by the central ministries/departments, states, districts and other stakeholders, in a time bound manner.
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Guidelines for Handling Temperature Sensitive Vaccines and Pharmaceuticals
WHO Regional Publications, Western Pacific Series No. 23
Reports the findings and recommendations of a working group convened to prepare guidelines for the use of herbal medicines in Western Pacific countries. Addressed to national health authorities, the report responds to the widespread use o...f herbal medicine in this part of the world and the corresponding need for mechanisms to ensure that these products are safe and effective, yet remain broadly accessible. With this need in mind, the report sets out a comprehensive framework for developing national policies designed to control the safety, efficacy, and quality of herbal medicines, manufacturing practices, product registration, and labelling, marketing, and trade.
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This is the first NAP on the Prevention and Containment of AMR in Kenya. It has been developed based on the National Policy on Prevention and Containment of AMR and the recommendations of the situation analysis on AMR conducted in 2011 and updated in 2016. This strategy provides a regulatory and imp...lementation framework to establish and strengthen systems to contain the emergence and spread of AMR. Implementation of this strategy will require substantial funding and high-level political commitment. Because AMR is a multidisciplinary and intersectoral issue, successful implementation of this strategy will require effective coordination and collaboration among different sectors.
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This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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interim guidance, 14 June 2021
This document is intended for national authorities and decision makers in countries that have introduced large scale public health and social measures. It offers guidance for adjusting public health and social measures, while managing the risk of a resurgence of cases....
Available in English, Arabic, Chinese, French, Russian and Spanish
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The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to... patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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