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Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-
...
in-
come countries (LMICs). While the COVID-19 pandemic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
more
Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficu
...
lt to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools.
more
Guidelines for Medicine Donations
recommended
This 3rd edition of Guidelines for medicine donations has been developed by the World Health Organization (WHO) in cooperation with major international agencies active in humanitarian relief and development assistance. The guidelines are intended to
...
improve the quality of medicine donations in international development assistance and emergency aid. Good medicine donation practice is of interest to both donors and recipients...
more
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.
more
These guidelines for the National Pharmacovigilance and Medicine Information System in Rwanda have been developed to ensure that safe, efficacious and quality medicines are made available to all Rwandans.
Accessed Febr. 6, 2020
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 to protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
more
The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of the most important tools for this measure.
Curriculum reform efforts to enhance training on rational medicine use (RMU) and AMR should pay particular attention to ensuring that the right topics are integrated and the right teaching-learning methodologies are adopted.
5th revised edition.
This document provides a ranking of medically important antimicrobials for risk management of antimicrobial resistance due to non-human use. The current revision took place at the seventh meeting of the AGISAR held in Raleigh, United States of America in 2016.
Rwanda Guidelines for variation to registered pharmaceutical products.
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingui
...
sh between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
more
Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vagi
...
nalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
more
The document contains a set of indicators that can be used for monitoring traditional and complementary medicine (T&CM) systems in a country.
The core indicator set consists of 16 indicators that were considered essential and collectively able to p
...
rovide information on T&CM inputs, processes and outputs. A longer list of reference indicators is also available for countries that wish to monitor more indicators or that want to consider alternative metrics that would better suit each country’s T&CM situation, priorities and monitoring capacities.
Each core and reference indicator is accompanied by a set of metadata. This provides information on the indicator rationale, definitions, data elements (numerator, denominator and data disaggregation), frequency of measurement, and data sources. It is a guide towards more standardized data measurement as well as data interpretation.
more
