The Trends and Developments report presents a top-level overview of the drug phenomenon in Europe, covering drug supply, use and public health problems as well as drug policy and responses. Together with the online Statistical Bulletin and 30 Country Drug Reports, it makes up the 2019 European Drug ...Report package.
Available in different languages: http://www.emcdda.europa.eu/publications/edr/trends-developments/2019_en
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Table of contents:
- Preface
- Introductory note and acknowledgements
- Commentary
- Chapter 1: Drug supply and the market
- Chapter 2: Drug use prevalence and trends
- Chapter 3: Drug-related harms and responses
- Annex: National data tables
Available in 24 languages on:
http://www.emcdd...a.europa.eu/publications/edr/trends-developments/2018
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Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi...demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
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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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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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The new guidelines provide public health guidance on pharmacological agents for managing hyperglycaemia in type 1 and type 2 diabetes for use in primary health-care in low-resource settings. These guidelines update the recommendations for managing hyperglycaemia in the WHO Package of Essential NCD I...nterventions (WHO PEN) for primary care in low-resources settings, reviewing several newer oral agents as second- and third-line treatment: dipeptidyl peptidase-4 inhibitors, sodium-glucose co-transporter 2 inhibitors and thiazolidinediones. The guidelines also present recommendations on the selection of type of insulin (analogue versus human insulin) for adults with type 1 and type 2 diabetes.
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This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o...f the product. The scope of the guidance extends to VMPs intended for food producing species and to the transmission of AMR by the foodborne route or through direct contact with treated animals.
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The second ECDC/EFSA/EMA joint report on the integrated analysis of antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in bacteria from humans and food-producing animals addressed data obtained by the Agencies’ EU-wide surveillance networks for 2013–2015. AMC in both sectors, exp...ressed in mg/kg of estimated biomass, were compared at country and European level. Substantial variations between countries were observed in both sectors. Estimated data on AMC for pigs and poultry were used for the first time. Univariate and multivariate analyses were applied to study associations between AMC and AMR. In 2014, the average AMC was higher in animals (152 mg/kg) than in humans (124 mg/kg), but the opposite applied to the median AMC (67 and 118 mg/kg, respectively). In 18 of 28 countries, AMC was lower in animals than in humans. Univariate analysis showed statistically-significant (p < 0.05) associations between AMC and AMR for fluoroquinolones and Escherichia coli in both sectors, for 3rd- and 4th-generation cephalosporins and E. coli in humans, and tetracyclines and polymyxins and E. coli in animals. In humans, there was a statistically-significant association between AMC and AMR for carbapenems and polymyxins in Klebsiella pneumoniae. Consumption of macrolides in animals was significantly associated with macrolide resistance in Campylobacter coli in animals and humans. Multivariate analyses provided a unique approach to assess the contributions of AMC in humans and animals and AMR in bacteria from animals to AMR in bacteria from humans. Multivariate analyses demonstrated that 3rd- and 4th-generation cephalosporin and fluoroquinolone resistance in E. coli from humans was associated with corresponding AMC in humans, whereas resistance to fluoroquinolones in Salmonella spp. and Campylobacter spp. from humans was related to consumption of fluoroquinolones in animals. These results suggest that from a ‘One-health’ perspective, there is potential in both sectors to further develop prudent use of antimicrobials and thereby reduce AMR.
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La Agencia Española de Medicamentos y Producto Sanitarios (AEMPS) está monitorizando de manera continua con los expertos de las agencias europeas, la EMA y el resto de agencias mundiales todos los datos relativos al uso de medicamentos para tratar la COVID-19. Se trata de... un escenario que puede ir cambiando por la enorme cantidad de datos, comunicaciones y publicaciones que se están generando a nivel mundial. El presente documento técnico tiene la finalidad de guiar el manejoclínicode los pacientes conCOVID-19 con un doble objetivo: lograr el mejor tratamiento del paciente que contribuya a su buena evolución clínica; y garantizar los niveles adecuados de prevención y control de la infección para la protección de los trabajadores sanitarios y de la población en su conjunto.
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The ECDC, the EFSA and the EMA have for the first time jointly explored associations between consumption of antimicrobials in humans and food-producing animals, and antimicrobial resistance in bacteria from humans and food-producing animals, using 2011 and 2012 data currently available from their re...levant five EU monitoring networks. Combined data on antimicrobial consumption and corresponding resistance in animals and humans for EU MSs and reporting countries were analysed using logistic regression models for selected combinations of bacteria and antimicrobials. A summary indicator of the proportion of resistant bacteria in the main food-producing animal species was calculated for the analysis, as consumption data in food-producing animals were not available at the species level
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23 April 2020EMA/202483/2020 Rev
Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have similar effects on the heart.
The European Medicines Agency (EMA) is evaluating potential COVID-19 treatments and vaccines to enable promising medicines to reach patients as soon as possible. It is also interacting with medicine developers and making use of real-world data to monitor the safety and effectiveness of medicines use...d in patients with COVID-19.
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An overview of COVID-19 Vaccine AstraZeneca and why it is authorised in the EU. Available in 22 languages
18 Febr. 2021
7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonization (AMRH) Initiative, and the World Health Organisat...ion’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
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This report provides an overview of the main findings of the 2019–2020 harmonised AMR monitoring in the main food-producing animal populations monitored, in carcase/meat samples and in humans. Where available, monitoring data obtained from pigs, calves, broilers, laying hens and turkeys, as well a...s from carcase/meat samples and humans were combined and compared at the EU level, with particular emphasis on multidrug resistance, complete susceptibility and combined resistance patterns to critically important antimicrobials, as well as Salmonella and E. coli isolates possessing ESBL-/AmpC-/carbapenemase phenotypes.
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