Myanmar’s transition to a market‐based economy is accompanied by rapid development of the private manufacturing sector, which has large potential for improving economic growth. The overall success of the sector, however, should not be taken for granted. Future advances will greatly depend on th...e policy and business environment in which manufacturing activities take place. It is, therefore, important to better understand the business environment and help inform policies conducive to sustainable economic growth.
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The National pharmaceutical policy aligns itself to the Government vision for development of the health sector, as defined in Vision 2020, the Millennium Development Goals and the Economic Development for Poverty Reduction Strategy and the National Health Policy. The pharmacy policy addresses, among... other challenges, the establishment of functional National Medicines Regulatory Authority that will implement all the regulatory functions, lack of local manufacturing facilities, lack of pricing policy of health commodities and technologies in private sector. This policy is based on the following key priorities: the Quality assurance, accessibility and the rational use of medicines, other health commodities and technologies.
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This document provides the specifications for major pesticide application equipment used for control of vectors of diseases. The specification guidelines contained herein are intended to assist national authorities and other public health users in selecting equipment of assured quality for applicati...on of pesticides for vector control.
The test methods described herein are intended to assess whether the equipment will function for a minimum of three years with appropriate routine maintenance according to the manufacturer’s label instructions. Manufacturers shall be requested to provide warranty against manufacturing defects with guaranteed after-sales service on the equipment, any certification required by national authorities regarding materials used in the construction of the equipment, and results of tests that have been carried out for compliance with national or international specifications.
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Long-lasting insecticidal nets (LNs) constitute a core vector control intervention against malaria. A number of new LN products are under development and will require assessment of risks to humans. This document provides an updated generic model that can be used for the risk assessment of exposure t...o insecticides of individuals sleeping under LNs and during the washing of nets.
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment.
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The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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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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14.04.2016
Pharm -Ed
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The alcohol-based solution for hand hygiene is now part of the WHO essential medicines list .Local production of the alcohol-based handrub is an alternative to commercial products. Although adapted to contexts with limited resources, it is essential to respect the Good Man...ufacturing Practices to ensure the quality, efficacy and safety of the product.
If you need production sheet, checklist of the material needed etc., please click on the following link: https://pharmed.datapharma.ch/courses...
Pharm-Ed (www.Pharm-Ed.net) is an initiative of the Pharmacy of the Geneva University Hospitals in Switzerland. The platform is free but registration (for free) is needed to access the e-learning courses and resources.
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After Corona was declared as a pandemic by WHO, multiple government agencies, development agencies, and departments needed technically accurate materials for their relevant contexts. Department for Labor and Human Resource, Government of Punjab needed something immediate for industrial workers in la...rge scale manufacturing settings particularly the textile sector which alone employs millions of workers.
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Improvements in water sanitation and hygiene (WASH) and wastewater management in all sectors are critical elements of preventing infections and reducing the spread of antimicrobial resistance (AMR) as identified in the Global Action Plan to combat AMR. Yet, at present, WASH and wastewater management... actors and improvement actions are under-represented in AMR multi-stakeholder platforms and national action plans (NAPs). This WHO/FAO/OIE technical brief on WASH and wastewater management to reduce the spread of AMR provides a summary of evidence and rationale for WASH and wastewater actions within AMR NAPs and sector specific policy to combat AMR. Evidence and actions are presented in the domains of; coordination and leadership, households and communities, health care facilities, animal and plant production, manufacturing of antimicrobials, and surveillance and research.
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The interactive report calls for ramped-up investment in health infrastructure worldwide to address yawning resource gaps in vaccine research, development, and manufacturing capacity.
Key findings:
• The pandemic pushed an additional 31 million people into “dire poverty” and backpedaled pro...gress toward eliminating poverty by 4 years
• Global rates for routine childhood vaccinations, such as malaria, fell last year by 7%, to levels not seen since 2005.
You can find a lot of excellent information and graphics
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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One of the many gender inequities in the health and care workforce that COVID-19 has exposed is around the fit and design of Personal Protective Equipment (PPE). The rapid onset and scale of COVID-19 led to shortages of PPE in most countries, causing preventable infection and mortality among healthc...are workers and others on the front lines. Even though most health workers are women, manufacturing specifications for medical PPE are usually drawn up based on the male body and there have been many reports of PPE not designed for women's bodies.
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One of the many gender inequities in the health and care workforce that COVID-19 has exposed is around the fit and design of Personal Protective Equipment (PPE). The rapid onset and scale of COVID-19 led to shortages of PPE in most countries, causing preventable infection and mortality among healthc...are workers and others on the front lines. Even though most health workers are women, manufacturing specifications for medical PPE are usually drawn up based on the male body and there have been many reports of PPE not designed for women's bodies. WGH undertook a global research project to document the challenges women health workers have faced.
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One of the many gender inequities in the health and care workforce that COVID-19 has exposed is around the fit and design of Personal Protective Equipment (PPE). The rapid onset and scale of COVID-19 led to shortages of PPE in most countries, causing preventable infection and mortality among healthc...are workers and others on the front lines. Even though most health workers are women, manufacturing specifications for medical PPE are usually drawn up based on the male body and there have been many reports of PPE not designed for women's bodies.
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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...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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This document summarizes the results of the WHO-commissioned full value proposition for new tuberculosis (TB) vaccines. The assessment was commissioned to provide early evidence for national and global decision-makers involved in TB vaccine development and implementation, who include stakeholders in...volved in vaccine research, financing, regulation and policy-making, manufacturing, introduction and procurement. The goal is to accelerate development of effective vaccines against TB and their rapid introduction into countries.
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Food is one of the most traded goods, and the conflict in Ukraine, one of the European breadbaskets, has triggered a significant additional disruption in the global food supply chains after the COVID-19 impact. The disruption to food output, supply chains, availability, and affordability could have ...a long-standing impact. As a result, the availability and supply of a wide range of food raw materials and finished food products are under threat, and global markets have seen recent increases in food prices. Furthermore, the Russian-Ukrainian conflict has adversely affected food supply chains, with significant effects on production, sourcing, manufacturing, processing, logistics, and significant shifts in demand between nations reliant on imports from Ukraine.
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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...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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Neglected tropical diseases (NTDs) are targeted for global control or elimination. Recognising that the populations most in need of medicines to target NTDs are those least able to support and sustain them financially, the pharmaceutical industry created mechanisms for donating medicines and experti...se to affected countries through partnerships with the WHO, development agencies, non-governmental organisations and philanthropic donors. In the last 30 y, companies have established programmes to donate 17 different medicines to overcome the burden of NTDs. Billions of tablets, capsules, intravenous and oral solutions have been donated, along with the manufacturing, supply chains and research necessary to support these efforts. Industry engagement has stimulated other donors to support NTDs with funds and oversight so that the ‘heath benefit’ return on investment in these programmes is truly a ‘best value in public health’. Many current donations are ‘open-ended’, promising support as long as necessary to achieve defined health targets. Extraordinary global health advances have been made in filariasis, onchocerciasis, trachoma, trypanosomiasis, leishmaniasis, schistosomiasis, intestinal parasites and others; and these advances are taking place in the context of strengthening health systems and meeting the global development goals espoused by the WHO. The pharmaceutical manufacturers, already strong collaborators in initiating or supporting these disease-targeted programmes, have committed to continuing their partnership roles in striving to meet the targets of the WHO’s new NTD roadmap to 2030.
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The UK government hosted the Global Vaccine Summit on June 4, 2020 under the patronage of the Rt. Hon. Boris Johnson, Prime Minister of the United Kingdom of Great Britain and Northern Ireland. The meeting was held by videoconference in light of the ongoing COVID-19 pandemic. 2. The Summit brought... together more than 300 people, including 42 Heads of State and Government. 62 countries were represented, notably 14 Gavi implementing countries, all of the G7 nations and 19 governments of the G20. Eminent participants also included H.E. Antonio Guterres, Secretary-General of the United Nations; H.E. Moussa Faki Mahamat, Chairperson of the African Union Commission; H.E. Dr Tedros Adhanom Ghebreyesus, WHO Director-General; H.E. Henrietta Fore, UNICEF Executive Director; Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation; Ministers from implementing and donor countries; CEOs of vaccine manufacturing companies and private sector partners; leaders of UN and other international agencies; senior civil society representatives; and Gavi champions. A full list of the participants can be found in Annex.
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