Economic Issues, Policies and Option for Action
A survival guide for clinicans.
3rd edition.
This Indicator-Based Pharmacovigilance Assessment Tool (IPAT) was developed as a comprehensive performance metric for pharmacovigilance and medicine safety systems.
Therapeutics Information and Pharmacovigilance Centre | TIPC
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 guid
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ance 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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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 com
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ponent 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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The mandate of the National Tuberculosis Control Programme is to provide leadership and stewardship to accelerate intense and coordinated efforts to reduce the adult TB burden of 290 per 100,000 pop
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ulation recently established in the 2013 National TB Prevalence Survey. Other key challenges are low TB case notification, unacceptably high TB death rates, low antiretroviral therapy (ART) coverage among TB/HIV patients and low drug-resistant notification and treatment.
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There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide
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the drug development process towards important regimen characteristics corresponding to the needs of end-users.
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This document builds on the Background document prepared for the September 4-5, 2014 Consultation. It includes proposed elements to consider during the development of a framework to assist decision-making at global and national level.
The aim of
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the document is to assist Member States and relevant partners in their discussions to identify the best approaches to ensure the accelerated evaluation and use of available or near-term therapies and vaccines for the treatment and prevention of EVD. The document calls for a coordinated effort by the international community to remove unnecessary obstacles towards this goal.
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National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination
Accessed: 08.10.2019
This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules)
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and non-traditional antibacterial agents in development worldwide. It evaluates to what extent the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
Division of Tuberculosis Elimination.
Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability of DAAs has impr
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oved significantly, but access remains lim-
ited. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
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Examination of the business behaviour of Boehringer Ingelheim, Bayer and Baxter in Uganda
The new guidelines provide public health guidance on pharmacological agents for managing hyperglycaemia in type 1 and type 2 diabetes for use in primary health-care in low-resource settings. These guidelines update the recommendations for managing h
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yperglycaemia in the WHO Package of Essential NCD Interventions (WHO PEN) for primary care in low-resources settings, reviewing several newer oral agents as second- and third-line treatment: dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors and thiazolidinediones. The guidelines also present recommendations on the selection of type of insulin (analogue versus human insulin) for adults with type 1 and type 2 diabetes.
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