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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Le renforcement des actions de promotion de l’allaitement maternel notamment la mise au sein précoce et l’allaitement maternel exclusif pendant les six premiers mois de vie, constitue est une priorité absolue dans la stratégie de réduction de la mortalité infantile au Bénin. En effet, le l...ait maternel est l’aliment idéal pour les nouveau-nés et les nourrissons. L’allaitement maternel est un puissant rempart contre la diarrhée, les infections respiratoires aiguës et la malnutrition.
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Patients with retreatment tuberculosis (TB) represent those
who have been treated previously for onemonth ormorewith
anti-TB drugs and who have been diagnosed once again with
the disease.These patientsmainly include relapses, treatment
after failure, or loss to follow-up on a first-line treatmen...t
regimen [1]. The number of these patients is not negligible.
In 2014, of the 6.3 million TB cases that were notified
by National TB Programmes (NTPs) to the World Health
Organization (WHO), approximately 700,000 patients were
already previously treated
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Journal of Tuberculosis Research, 2017, 5, 189-200
Background: In Benin, little is known about the influence of both gender and
HIV-status on diagnostic patterns and treatment outcomes of Tuberculosis
(TB) patients. Objective: To assess whether differences in gender and HIV
status affect diagn...ostic patterns and treatment outcomes of TB patients. Methods:
Retrospective cohort study of patients registered in 2013 and 2014 in
the three largest TB Basic Management Units in south Benin. Results: Of 2694
registered TB patients, 1700 (63.1%) were male. Case notification rates were
higher in males compared with females (96 vs 53/100,000 inhabitants). The
male to female ratio was 1:1 in HIV positive patients, but was 2:1 among HIV
negative cases. In HIV-positive patients, there were no differences in TB types
between men and women. In HIV-negative patients, there were significantly
higher proportions of females with clinically diagnosed pulmonary TB (p =
0.04) and extrapulmonary TB (p < 0.001). Retreatment TB was 4.65 times
higher amongst males compared with females. For New bacteriologically confirmed
pulmonary TB, no differences were observed in treatment outcomes
between genders in the HIV positive group; but significantly more unfavorable
outcomes were reported among HIV negative males, with higher rates of
failure (p < 0.001) and loss-to-follow up (p = 0.02). Conclusion: The study
has shown that overall TB notification rates were higher in males than in females
in south Benin, with more females co-infected with HIV. Unfavorable outcomes were more common in HIV-negative males.
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The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for... the first two to five products to become available in about 10 years.
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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Oxford Policy Management (OPM) - APW with UNAIDS (thru TSF)
Experiences from Indonesia, Kenya, Uganda and Ukraine
Agenda item 5, UNAIDS/PCB (43)/18.
11-13 December 2018 | Geneva, Switzerland
UNAIDS Programme Coordinating Board
Issue date: 23 November 2018
Nature Reviews Microbiology Vol. 17 (2019)pp.51-62
Antimicrobial susceptibility testing (AST) technologies help to accelerate the
initiation of targeted antimicrobial therapy for patients with infections and could potentially
extend the lifespan of current narrow- spectrum antimicrobials. Althoug...h conceptually new and
rapid AST technologies have been described, including new phenotyping methods, digital
imaging and genomic approaches, there is no single major, or broadly accepted, technological
breakthrough that leads the field of rapid AST platform development
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Ramped-up cancer services could save 7 million lives over the next decade—and addressing huge service gaps between rich and poor countries is key to success, according to this report.
In 2019, over 90% of high-income countries reported that comprehensive cancer treatment services were available... through the public health system, compared to fewer than 15% of low-income countries, according to WHO.
But poorer countries can make substantial strides with a universal health coverage approach and use of the latest science to meet their particular needs.
The report lays out proven ways to prevent new cancer cases without breaking the bank, including tobacco-control measures and vaccines that protect against common cancers.
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In aquaculture, antibiotics have been used mainly for therapeutic purposes and as prophylactic agents. The contribution to antimicrobial resistance of antibiotics used in aquaculture is reviewed here, using a risk analysis framework. Some recommendations on responsible conduct in this context are pr...oposed, aimed at diminishing the threat of build up of antimicrobial resistance.
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Despite Pakistan's progress in reducing the number of wild poliovirus type 1 (WPV1) cases to 8 in 2017 and 12 in 2018, 2019 has seen a significant rise in the number of WPV1 cases (41 cases as of July 8 2019). One of the most intractable challenges the Pakistan Polio Eradication Initiative (PEI) is ...facing is refusals by parents and caregivers to immunise their children with the polio vaccine. In light of this challenge, the Pakistan programme has revisited its strategy and put forward this Extension of the National Emergency Action Plan 2018/2019 (NEAP), which will carry the programme forward from July to December 2019
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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 objectives 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.
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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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1st edition
This resource provides practical guidance for front line health workers responsible for the diagnosis, management and care of patients with these two diseases. Published in collaboration with the World Diabetes Foundation
Le défi des pays en voie de développement est la disponibilité de méthodes de diagnostic rapide et précis pour le management de la tuberculose. Des techniques moléculaires offrent cet avantage et nous avons utilisé le test GeneXpert MTB/RIF dans le diagnostic de la tuberculose extra-pulmonair...e pour évaluer sa performance par rapport aux méthodes conventionnelles.
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