Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M
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edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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A view of global supply chains, pressure points, and implications for antimicrobial resistance response
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to
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understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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WHO/HIV/SIP
Accessed: 28.11.2019
The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys
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tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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The coronavirus disease (COVID-19) pandemic exacerbated pre-existing inequalities in the treatment and care of noncommunicable diseases (NCDs). This report examines the effect of the COVID-19 pandemic on access to NCD medicines, and the policies and strategies implemented by countries and health sys
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tems to anticipate and mitigate stresses across NCD medicine supply chains. The full range of upstream and downstream impacts are investigated, including: manufacturing; procurement, importation and last mile delivery; patient-level effects through affordability and availability; and the effects on NCD medicine availability by category of disease. The report culminates in recommended actions and interventions for key stakeholders in the NCD pharmaceutical supply chain, including governments, regulatory authorities, manufacturers and the private sector; as well as directions for future research for improving access and supply chain access resilience.
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The primary aim of this assessment is to evaluate current approaches to malaria surveillance in Myanmar and to provide a set of practical and feasible recommendations to further strengthen the surveillance system in the short to medium term. The assessment focuses on the surveillance of malaria case
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s (as distinct from more general surveillance to support monitoring and evaluation) and, more specifically, on instruments and systems to collect, collate, report and analyse malaria data as a basis for informing malaria control policy and practice.
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Journal of The Association of Physicians of India, Vol. 63 November 2015,, pp.77-96
Web page access : 28.04.2017
Guidance for the prevention of volcanic ash rain: before, during and after the ash rain
Be-Friended to the Volcano : a guidance or manual book for school children in Indonesia of health crisis prevention during the natural disaster
Minimizing risk of developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotic.
The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure t
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hat their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
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PNAS 119 (8) e2113947119 | https://doi.org/10.1073/pnas.2113947119
Environmental exposure to active pharmaceutical ingredients (APIs) can have negative effects on the health of ecosystems and humans. While numerous studies have monitored APIs in rivers, these employ different analytical methods, m
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easure different APIs, and have ignored many of the countries of the world. This makes it difficult to quantify the scale of the problem from a global perspective. Furthermore, comparison of the existing data, generated for different studies/regions/continents, is challenging due to the vast differences between the analytical methodologies employed. Here, we present a global-scale study of API pollution in 258 of the world’s rivers, representing the environmental influence of 471.4 million people across 137 geographic regions. Samples were obtained from 1,052 locations in 104 countries (representing all continents and 36 countries not previously studied for API contamination) and analyzed for 61 APIs. Highest cumulative API concentrations were observed in sub-Saharan Africa, south Asia, and South America. The most contaminated sites were in low- to middle-income countries and were associated with areas with poor wastewater and waste management infrastructure and pharmaceutical manufacturing. The most frequently detected APIs were carbamazepine, metformin, and caffeine (a compound also arising from lifestyle use), which were detected at over half of the sites monitored. Concentrations of at least one API at 25.7% of the sampling sites were greater than concentrations considered safe for aquatic organisms, or which are of concern in terms of selection for antimicrobial resistance. Therefore, pharmaceutical pollution poses a global threat to environmental and human health, as well as to delivery of the United Nations Sustainable Development Goals.
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4th edition.
This report – now in its fourth edition – analyses the barriers and factors affecting access to treatment regimens for drug-resistant tuberculosis (DR-TB), including new and repurposed drugs. We provide detailed pricing profiles of key DR-TB drugs, using manufacturer responses to s
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tandardised questionnaires and the Global TB Drug Facility website.
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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 improved significantly, but access remains lim-
i
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ted. 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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