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.
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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These guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in our country.
The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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2nd edition .
This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits. This Framework does not apply to seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical ...specimens shared under this Framework
This second edition of the Pandemic Influenza Preparedness (PIP) Framework reflects an amendment to Annex 2, Standard Material Transfer Agreement 2, Footnote 1, that was adopted by the Seventy-second World Health Assembly in May 2019.The amendment clarifies that, under certain circumstances, the indirect use of PIP Biological Materials will require the conclusion of an SMTA2. The amendment is in effect from the closure of the Seventy-second World Health Assembly (28 May 2019).
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Climate change is damaging human health now and is projected to have a greater impact in the future. Low- and middle-income countries are seeing the worst effects as they are most vulnerable to climate shifts and least able to adapt given weak health systems and poor infrastructure. Low-carbon appro...ach can provide effective, cheaper care while at the same time being climate smart. Low-carbon healthcare can advance institutional strategies toward low-carbon development and health-strengthening imperatives and inspire other development institutions and investors working in this space. Low-carbon healthcare provides an approach for designing, building, operating, and investing in health systems and facilities that generate minimal amounts of greenhouse gases. It puts health systems on a climate-smart development path, aligning health development and delivery with global climate goals. This approach saves money by reducing energy and resource costs. It can improve the quality of care in a diversity of settings. By prompting ministries of health to tackle climate change mitigation and foster low-carbon healthcare, the development community can help governments strengthen local capacity and support better community health.
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Project Paper to provide an additional grant for: Human Development Systems Strengthening Project (HDSSP)(P145965, H9360)
Non-Wood Forest Products 11
Traditional medicine and its use of medicinal plants is dependent on reliable supply of plant materials. The book focuses on the interface between medicinal plant use and conservation of medicinal plants.
Medicines and Allied Substances [No. 3 of 2013 47 | An Act to continue the existence of the Pharmaceutical Regulatory Authority and re-name it as the Zambia Medicines Regulatory Authority; provide for the functions and powers of the Authority; provide for the registration and regulation of pharmacie...s, health shops and agro-veterinary shops; provide for the registration and regulation of medicines and allied substances; provide for the regulation of the manufacture, importation, exportation, possession, storage, distribution, supply, promotion, advertising, sale and use of medicines and allied substances; provide for the regulation and control of clinical trials; repeal and replace the Pharmaceutical Act, 2004; and provide for matters connected with, or incidental to, the foregoing.
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A role for nuclear techniques
Antimicrobials play a critical role in the treatment of human and animal (aquatic and terrestrial) diseases, which has led to their widespread application and use. Antimicrobial resistance (AMR) is the ability of microorganisms to stop an antibiotic, such as an antimic...robial, antiviral or antimalarial, from working against them. Globally, about 700 000 deaths per year arise from resistant infections as a result of the fact that antimicrobial drugs have become less effective at killing resistant pathogens. Antimicrobial chemicals that are present in environmental compartments can trigger the development of AMR. These chemicals can also cause antibiotic-resistant bacteria (ARB) to further spread antibiotic resistance genes (ARG) because they may have an evolutionary advantage over non-resistant bacteria.
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The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibiotics. The severity of the consequences is clear to ...see: it is estimated that each year, drug-resistant infections result in at least 25 000 patient deaths and cost the EU EUR 1,5 billion in healthcare costs and through loss of productivity
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Antimicrobial resistance (AMR) both in human and veterinary medicine has reached alarming levels in
most parts of the world and has now been recognized as a significant emerging threat to global public
health and food security. In June 2015, the Food and Agriculture Organization of the United Nati...ons
(FAO) passed a resolution on AMR at its governing
Conference. This followed the adoption of counterpart
resolutions on AMR by The World Organisation
for Animal Health (OIE) and the World Health Organization
(WHO) in May 20152, and marked the
beginning of a joint effort by the three organizations
to combat AMR globally.
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This short paper aims to identify key evidence gaps in our knowledge of livestock- and fisheries-linked antimicrobial resistance in the developing world, and to document on-going or planned research initiatives on this topic by key stakeholders.
The antimicrobial resistant (AMR) infections in anima...ls that are of most potential risk to human health are likely to be zoonotic pathogens transmitted through food, especially Salmonella and Campylobacter. In addition, livestock associated methicillin resistant Staphylococcus aureus (LA MRSA) and extended spectrum beta lactamase E. coli (ESBL E. coli) are emerging problems throughout the world.
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Since the introduction of penicillin in the early twentieth century, antimicrobial treatments have been utilized not only in human medicine but also in veterinary care – initially to ward off diseases, prevent post-surgery infections, and treat sick farm animals.Global food production... has intensified over the past 50 years due to economic expansion and popu-lation growth. The use of antimicrobials in agriculture – in livestock, fish farming, and even on crops – has grown as well. Antimicrobials are not only used as medicines, but are sometimes also added in low concentrations to animal feed as a way of stimulating growth.
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Global actions to reduce antimicrobial resistance (AMR) include optimising the use of antimicrobial medicines in human and animal health. In countries with weak healthcare regulation, this requires a greater understanding of the drivers of antibiotic use from the perspective of providers and consume...rs. In Bangladesh, there is limited research on household decision-making and healthcare seeking in relation to antibiotic use and consumption for humans and livestock. Knowledge is similarly lacking on factors influencing the supply and demand for antibiotics among qualified and unqualified healthcare providers. The aim of this study is to conduct integrated research on household decision-making for healthcare and antibiotic use, as well as the awareness, behaviours and priorities of healthcare providers and sellers of antibiotics to translate into policy development and implementation
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In Kenya, the bacterial infections that contribute most to human disease are often those in which re-‐sistance is most evident. Examples are multidrug-‐resistant enteric bacterial pathogens such as typhoid, ... diarrhoeagenic Escherichia coli and invasive non-‐typhi salmonella, penicillin-‐resistant Streptococcus pneu-‐moniae, vancomycin-‐resistant enterococci, methicillin-‐resistant Staphylococcus aureus and multidrug-‐re-‐sistant Mycobacterium tuberculosis. Resistance to medicines commonly used to treat malaria is of particu-‐lar concern, as is the emerging resistance to anti-‐HIV drugs. Often, more expensive medicines are required to treat these infections, and this becomes a major challenge in resource-‐poor settings.
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High prices, hard-to-access human insulin, few insulin producers, and weak health systems are just some of the barriers that people with diabetes face a century after insulin was discovered, WHO notes in a new report
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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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...hat their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
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Access to safe blood and blood products is recognized as one of the key requirements for delivery of modern health care in the journey towards health for all. The foundation of safe and sustainable blood supplies depends on the collection of blood from voluntary non-remunerated and low-risk donors. ...Data from the WHO Global Database for Blood Safety (GDBS) brings out several inadequacies related to the supply and safety of blood and blood products. These inadequacies include a number of variations in safe blood practices across the world, including the quantity of blood donated (voluntary and replacement types), quality and adequate testing of the donated blood (immunohaematology [IH] and transfusion-transmitted infections [TTIs]), rational use of blood and blood components such as appropriate patient blood management protocols. These variations are very high in countries of the South-East Asian Region and most of them are either low- or middle-income countries (LMICs).
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