Technical Update
HIV Treatment
July 2017
Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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May 2018
HIV i-Base
ISSN 1475-2077 www.i-Base.info
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In recognition of the growing problem of antimicrobial resistance (AMR), its increasing threat to human, animal and plant health, and the need for a One Health approach to address this issue, the 39th Session of the Codex Alimentarius Commission (CAC) agreed it was important for the food safety comm...unity to play its part and re-established the ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) ). The objectives of the Task Force were
to revise the current Codex Code of Practice to Minimise and Contain Antimicrobial Resistance and to develop new guidance on surveillance programmes relevant to foodborne AMR.
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Textes du Codex concernant la résistance aux antimicrobiens d’origine alimentaire
Textos del Codex sobre la resistencia a los antimicrobianos transmitida por los alimentos
Antimicrobial resistance (AMR) is a major global public health concern and a food safety issue. When pathogens become r...esistant to antimicrobial agents they can pose a greater human health risk as a result of potential treatment failure, loss of treatment options and increased likelihood and severity of disease
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The International Pharmaceutical Federation (FIP) is a global federation of national associations of pharmacists and
pharmaceutical scientists. In order to support these associations in their fight against AMR, FIP has prepared this
briefing document. It is an overview of the different activities ...that community and hospital pharmacists are involved
into prevent AMR and to reverse AMR rates.
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This paper was developed to support AMR coordination committees and others tasked with addressing AMR at country level to do just that. Drawing on the published literature and the operational experience and expertise of different LMICs, the paper points to six key strategies for success and offers a... series of practical tips and suggestions on how to implement each one.
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This handbook follows a comprehensive approach to health system strengthening at borders in order to support IHR national focal points and other national agencies in developing and implementing evidence-based action plans for IHR capacity development at ground crossings. The approach includes the mo...vement of travellers and baggage, cargo, containers, conveyances, goods and postal parcels across ground crossings, as well as the interaction with adjacent border communities. Other factors can be considered, if needed, throughout the risk assessment.
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The National Department of Health and Department of Agriculture, Forestry and Fisheries have collectively engaged to determine the key interventions that will form the basis for this strategy taking into account the recommendations from the WHO and OIE.
The development and implementation of a Natio...nal Antimicrobial Resistance Strategy Framework that complements international efforts is a major step towards containment of the growing threat of antimicrobial resistance in human and animal health. Global partnerships need to be strengthened because the responsibility for reducing resistance is a shared one. This responsibility is not only limited to the health care sector, but calls for collaborative action in all sectors - human, animal and agriculture.
The National Antimicrobial Resistance Strategy Framework will affect South Africa’s response to this looming threat. We already have the tools and expertise to make a difference, now all we need is to work together toward a better future.
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On 31st December 2019, the World Health Organization (WHO) China Country Office was informed of cases of pneumonia of unknown etiology (unknown cause) detected in Wuhan City, Hubei Province of China. On 7th January 2020, Chinese authorities identified a new strain of Coronavirus as the causative age...nt for the disease. The virus has been renamed by WHO as SARS-CoV-2 and the disease caused by it as COVID-19. The disease since its first detection in China has now spread to over 200 countries/territories, with reports of local transmission happening in more than 160 of these countries/territories. As per WHO (as of 1st April, 2020), there has been a total of 823626 confirmed cases and 40598 deaths due to COVID-19 worldwide.
In India, as on 2nd April, 2020, 1965 confirmed cases (including 51 foreign nationals) and 50 deaths reported from 29 States/UTs. Large number of cases has been reported from Delhi, Karnataka, Kerala, Maharashtra, Rajasthan, Tamil Nadu, Telangana and Uttar Pradesh.
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FAO’s component of the Global COVID-19 Humanitarian Response Plan
18.5.2020
Kenya reported its first case of COVID-19 on 12 March 2020 and, as at 7 April 2020, 172 cases had been confirmed and 6 deaths reported. The Government of Kenya has taken a number of measures to curb the spread of the virus, including implementing a curfew, restricting movement out and into four coun...ties, including Nairobi Metropolitan, and closing most of the urban and rural markets to enforce social distancing. However, these measures, along with the global economic shock caused by the pandemic, are expected to generate new needs, requiring an immediate and urgent response.
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South Africa reported it fist case of COVID-19 on 5 March 2020. While the first cases were imported, local transmission has led to a rapid increase in the number of cases. As of 21 April 2020, more than 3,400 cases and 58 deaths had been confirmed. On 15 March, President Cyril Ramaphosa declared a n...ational state of disaster, and the government has since taken several measures to curb the spread of the virus, including closing borders, implementing strict social distancing measures and a 35-day nation-wide lockdown. These measures, along with the global economic shock caused by the pandemic, are expected to generate rising needs requiring an immediate and urgent response. Although South Africa is considered an upper-middle-income country, the amount of disparities—social, economic, and gender—make the country particularly vulnerable during this emergency.
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- Interim guide: May 2020 update.
On the 25th of March, the GPEI circulated the first update of the interim guide to help ensure continuity of the programme’s operations in the context of the COVID-19 pandemic, as well as its support to the pandemic response while also ensuring the safety of its ...personnel and the communities it works with.
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Nested case-control study of health workers exposed to confirmed COVID-19 patients.
Similar objectives to the cohort study but case-control studies may be cheaper and provide robust evidence to characterize and assess the risk factors for SARS-CoV-2 infection in health workers exposed to COVID-19 p...atients.
Health workers with confirmed COVID-19 will be recruited as cases and other health workers in the same health care setting without infection will be recruited as controls (incidence density sampling).
Secondary objectives are similar to the cohort study.
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This document aims to provide global guidance on poliomyelitis (polio) surveillance in the context of the COVID-19 pandemic. It comes as a technical complement to Polio eradication programme continuity, Immunization in the context of COVID-19 pandemic frequently asked questions, and is aligned with ...the Global Polio Eradication Initiative (GPEI) commitment to support the COVID-19 pandemic response.
It highlights the decision making framework to guide the level of polio surveillance activities at country level including; the measures to put in place to ensure a minimum level of polio surveillance in the field and in the laboratory, and the trigger to return to normal polio function.
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As of 21 May 2020, 4.8 million confirmed cases of Coronavirus disease 2019 (COVID-19) have been reported globally. In South America, COVID-19 was first detected on 26 February 2020, when Brazil confirmed a case in São Paulo.