Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries
The 2018 Access to Medicine Index finds that the pharmaceutical industry continues to mature in its approach to access to medicine, with models for good practice in areas such as access planning and licensing. GSK retains its No. 1 position, as Novartis moves up into 2nd. Takeda rises furthest in 20...18, jumping ten places to fifth
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https://accesstomedicinefoundation.org/media/uploads/downloads/5c8bc9ceb714b_Access%20to%20Medicine%20Index%202018.pdf
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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 pan...demic 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.
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Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I...ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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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 guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its obj...ectives are to minimize the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance. It is also important to provide for the safe and effective use of veterinary antimicrobial drugs in veterinary medicine by maintaining their efficacy. This document defines the respective responsibilities of authorities and groups involved in the authorization, production, control, distribution and use of veterinary antimicrobials such as the national regulatory authorities, the veterinary pharmaceutical industry, veterinarians, distributors and producers of food-producing animals.
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Venezuela’s government announced on 24 March that COVID-19 infections had reached 91... “The government says wear masks, wash your hands often, and stay inside,” Gomez said. “But we don’t have water, we often don’t have electricity, and there are no masks.”...
[President] Maduro den...ies there are shortages in Venezuela, insisting in a national broadcast on 16 March that hospitals have all the mandatory equipment.
There is no news about when health workers will receive biosecurity equipment, which Maduro said was being shipped by China along with thousands of test kits.
He also claimed the country’s collapsed pharmaceutical industry would be able to produce both a treatment and a cure for coronavirus – neither of which exist.
He recommended to the nation a homemade “cure” promoted by one Venezuelan, one “given to us by our ancestors: pepper, lemon grass, honey and ginger”.
Although the World Health Organisation advises that only people suffering respiratory problems should wear masks, Maduro decreed: “No one can walk the streets without a mask.”
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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment ...of five leading vaccine manufacturers, AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna Inc., and Pfizer Inc. It also includes for the first time an assessment of the two largest Chinese vaccine producers, China National Pharmaceutical Group Co., Ltd. (Sinopharm) and Sinovac Biotech Ltd. (Sinovac).
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The Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted unanimously by all Member States in 2011. It brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. The Frame...work includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.
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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 Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted unanimously by all Member States in 2011. It brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. The Frame...work includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.
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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan...cements, industry practices and regulatory expectations specific to the vaccine manufacturing context. Some of the topics include computer system validation, data integrity, challenges in lyophilization and others. Real world examples and case studies will be used to show how to interpret current and recently new good manufacturing practices requirements from a practical point of view and to implement appropriate approaches.
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