scholarly journals Registering medicines for low-income countries: how suitable are the stringent review procedures of the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency?

2013 ◽  
Vol 19 (1) ◽  
pp. 23-36 ◽  
Author(s):  
Joachim Y. Doua ◽  
Jean-Pierre Van Geertruyden
Keyword(s):  
Drug Administration ◽  
Low Income ◽  
Food And Drug Administration ◽  
World Health Organisation ◽  
World Health ◽  
Low Income Countries ◽  
European Medicines Agency ◽  
The Us ◽  
The World

scholarly journals Tuberculosis and Non-Communicable Disease Multimorbidity: An Analysis of the World Health Survey in 48 Low- and Middle-Income Countries

2021 ◽  
Vol 18 (5) ◽  
pp. 2439
Author(s):  
Brendon Stubbs ◽  
Kamran Siddiqi ◽  
Helen Elsey ◽  
Najma Siddiqi ◽  
Ruimin Ma ◽  
...  
Keyword(s):  
Health Survey ◽  
Low Income ◽  
World Health ◽  
Low Income Countries ◽  
Multivariable Logistic Regression Analysis ◽  
World Health Survey ◽  
Middle Income ◽  
Middle Income Countries ◽  
The World ◽  
Low And Middle Income

Tuberculosis (TB) is a leading cause of mortality in low- and middle-income countries (LMICs). TB multimorbidity [TB and ≥1 non-communicable diseases (NCDs)] is common, but studies are sparse. Cross-sectional, community-based data including adults from 21 low-income countries and 27 middle-income countries were utilized from the World Health Survey. Associations between 9 NCDs and TB were assessed with multivariable logistic regression analysis. Years lived with disability (YLDs) were calculated using disability weights provided by the 2017 Global Burden of Disease Study. Eight out of 9 NCDs (all except visual impairment) were associated with TB (odds ratio (OR) ranging from 1.38–4.0). Prevalence of self-reported TB increased linearly with increasing numbers of NCDs. Compared to those with no NCDs, those who had 1, 2, 3, 4, and ≥5 NCDs had 2.61 (95% confidence interval (CI) = 2.14–3.22), 4.71 (95%CI = 3.67–6.11), 6.96 (95%CI = 4.95–9.87), 10.59 (95%CI = 7.10–15.80), and 19.89 (95%CI = 11.13–35.52) times higher odds for TB. Among those with TB, the most prevalent combinations of NCDs were angina and depression, followed by angina and arthritis. For people with TB, the YLDs were three times higher than in people without multimorbidity or TB, and a third of the YLDs were attributable to NCDs. Urgent research to understand, prevent and manage NCDs in people with TB in LMICs is needed.

Review of the scientific evidence used for establishing US policies on added sugars

2019 ◽  
Vol 77 (9) ◽  
pp. 646-661 ◽  
Author(s):  
Paula R Trumbo
Keyword(s):  
World Health Organization ◽  
Drug Administration ◽  
Scientific Evidence ◽  
Dietary Guidelines ◽  
World Health ◽  
Added Sugars ◽  
The Us ◽  
The World ◽  
Dietary Guidelines For Americans ◽  
Health Organization

AbstractThe 2015 Dietary Guidelines for Americans Advisory Committee has set recommendations to limit added sugars. This action was based on the association between dietary pattern quality scores and chronic disease risk, the results of meta-analyses conducted for the World Health Organization, and data from modeling of dietary patterns for establishing the US Department of Agriculture’s Healthy US-Style Eating Patterns. Recommendations provided by the 2015–2020 Dietary Guidelines for Americans were used by the US Food and Drug Administration to establish, for the first time, the mandatory declaration of added sugars and a Daily Value of added sugars for the Nutrition Facts label. This review provides an overview of the scientific evidence considered by the World Health Organization, the 2015–2020 Dietary Guidelines for Americans, and the US Food and Drug Administration for setting recent polices and regulations on added sugars and highlights important issues and inconsistencies in the evaluations and interpretations of the evidence.

The Content and Efficacy of Environmental Public Health Journal Homepages

2000 ◽  
Vol 12 (1) ◽  
pp. 32-36 ◽  
Author(s):  
Elaine S. Lindars ◽  
Jeff T. Spickett
Keyword(s):  
Public Health ◽  
World Health Organisation ◽  
World Health ◽  
Environmental Health Sciences ◽  
Environmental Public Health ◽  
The Us ◽  
The World ◽  
Public Money ◽  
Health Journal ◽  
High Degree

The information on several environmental public health journal homepages has been assessed for its quality and quantity, using selected key criteria. These criteria included the extent of text available, the ability to search the website, the table of contents free via email, and the presence of hyper-links. A high degree of variability is seen, with services and facilities offered ranging from none to the entire journal available for no fee. The journal homepages that are the most comprehensive are those that are associated with major institutions and hence financed by contributions from their members or public money, i.e. the British Medical Association, the World Health Organisation and the US National Institute of Environmental Health Sciences. The journal homepages associated with these institutions offered full text of both current and archived issues as well as additions such as the ability to search other sites, web links, and in some cases hyper-linked references and information on related articles. The provision of text on the Internet should be an essential aim for all journal Homepages, to ensure fast and effective conveyance of information to health professionals. Asia Pac J Public Health 2000;12(1): 32-36

scholarly journals A Systematic Review on COVID-19 Vaccine Strategies, Their Effectiveness, and Issues

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1387
Author(s):  
Shahad Saif Khandker ◽  
Brian Godman ◽  
Md. Irfan Jawad ◽  
Bushra Ayat Meghla ◽  
Taslima Akter Tisha ◽  
...  
Keyword(s):  
Systematic Review ◽  
Side Effects ◽  
Adverse Events ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Morbidity And Mortality ◽  
European Medicines Agency ◽  
Vaccine Candidates ◽  
Online Databases ◽  
The Us

COVID-19 vaccines are indispensable, with the number of cases and mortality still rising, and currently no medicines are routinely available for reducing morbidity and mortality, apart from dexamethasone, although others are being trialed and launched. To date, only a limited number of vaccines have been given emergency use authorization by the US Food and Drug Administration and the European Medicines Agency. There is a need to systematically review the existing vaccine candidates and investigate their safety, efficacy, immunogenicity, unwanted events, and limitations. The review was undertaken by searching online databases, i.e., Google Scholar, PubMed, and ScienceDirect, with finally 59 studies selected. Our findings showed several types of vaccine candidates with different strategies against SARS-CoV-2, including inactivated, mRNA-based, recombinant, and nanoparticle-based vaccines, are being developed and launched. We have compared these vaccines in terms of their efficacy, side effects, and seroconversion based on data reported in the literature. We found mRNA vaccines appeared to have better efficacy, and inactivated ones had fewer side effects and similar seroconversion in all types of vaccines. Overall, global variant surveillance and systematic tweaking of vaccines, coupled with the evaluation and administering vaccines with the same or different technology in successive doses along with homologous and heterologous prime-booster strategy, have become essential to impede the pandemic. Their effectiveness appreciably outweighs any concerns with any adverse events.

scholarly journals Democratizing Health Research

2020 ◽  
Author(s):  
Robert Fraser Terry ◽  
Erik Lieungh
Keyword(s):  
Low Income ◽  
Royal Society ◽  
Research Policy ◽  
Cultural Barriers ◽  
World Health ◽  
Low Income Countries ◽  
Research Assessment ◽  
The World ◽  
New Research ◽  
And Training

Is it fair that researchers and policymakers in low-income countries have to pay to read new research on diseases they treat? Today's guest is Robert Terry from the World Health Organization’s Special Programme for Research and Training in Tropical Diseases (TDR), where he works as a manager of research policy. His background is from both the Royal Society and the Wellcome Trust. For Terry, achieving open access requires addressing barriers across political, technical and cultural barriers, with the culture of research assessment and reward needing the biggest change to democratizing science. The host of this episode is Erik Lieungh. This episode was first published 16 December 2019.

North America's cannabis sector has enormous scope

2017 ◽  
Keyword(s):  
World Health Organisation ◽  
World Health ◽  
Content Type ◽  
North American Market ◽  
The Us ◽  
The World ◽  
Working Age ◽  
Recreational Marijuana ◽  
Drugs And Crime ◽  
Recreational Use

Subject The US cannabis market. Significance The World Health Organisation reports that cannabis is the most widely used psychoactive controlled substance across the world. Indeed, the UN Office on Drugs and Crime estimates that in 2014, 182.5 million working-age people used recreational marijuana. North America is the world's largest market for marijuana, cannabis's smoked herbal form, and legalisation for both medicinal and recreational use is building momentum, rapidly creating a massive new industry. Impacts The share of the global population using cannabis is around 3.8%, translating into a North American market of at least 18 million users. Canada is legalising cannabis next year while 29 US states and the District of Columbia have legalised medical or recreational use. Full US legalisation remains uncertain as the federal prohibition remains in place.

scholarly journals OC 8431 CLINICAL RESEARCH AND SUSTAINABLE DEVELOPMENT IN SUB-SAHARAN AFRICA: THE IMPACT OF NORTH-SOUTH PARTNERSHIPS

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A5.3-A6
Author(s):  
Agnes Saint-Raymond ◽  
Martin Harvey ◽  
Maria Cavaller
Keyword(s):  
Public Health ◽  
World Health Organisation ◽  
Sub Saharan Africa ◽  
World Health ◽  
European Medicines Agency ◽  
Local Conditions ◽  
The World ◽  
Significant Public Health ◽  
The Impact ◽  
The Eu

BackgroundThe European legislation introduced in 2004 (under article 58) a collaboration tool to increase access to high quality and effective medicines in low- and middle-income countries. The European Medicines Agency (EMA) can provide scientific opinions on medicines intended for significant public health needs, in partnership with the World Health Organisation (WHO) and the relevant ‘target’ non-EU regulatory authorities. This EU-Medicines4all (EU-M4all) initiative contributes to the broader Global Health Mandate of the EU.MethodsWe contacted the pharmaceutical companies holding ‘article 58’ scientific opinions and compiled the number of actual approvals based on these opinions.ResultsNine medicines have been assessed so far, most of them for HIV/AIDS, tuberculosis, malaria and maternal/new-born health. Although this figure may appear low, the impact of the corresponding scientific opinions is much wider. Approvals were granted in 66 different countries worldwide, 38 of which are in Africa, based on these opinions.DiscussionSuch scientific opinions on the quality, safety and efficacy of the medicines are provided by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Prior to this, it is recommended to agree on the data to be generated through scientific advice. The opinions are based on the same standards as used for those approved for Europe, with considerations for local conditions of use. To promote reliance on EMA scientific outputs and awareness of the procedure, two training events with regulators from Southern and from Western Africa are organised in partnership with WHO, NEPAD and local regulators in June 2018.ConclusionWe have shown that this ‘article 58’ procedure has a true impact and we encourage applications by companies developing medicines, aimed to prevent or treat diseases of significant public health interest, to be marketed outside the EU. This will ensure timely access of medicines by patients in target countries all over the world.

scholarly journals To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e028677 ◽  
Author(s):  
Thomas Christian Kühler ◽  
Magda Bujar ◽  
Neil McAuslane ◽  
Lawrence Liberti
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
European Medicines Agency ◽  
Regulatory Pathways ◽  
Time Period ◽  
The Us ◽  
New Chemical Entities ◽  
Assessment Guidelines ◽  
Available Information ◽  
Active Substances

ObjectiveTo compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016.DesignUsing publicly available information from FDA and EMA websites, new active substances (NASs) approved by each agency from 2014 to 2016 were identified and their characteristics assessed. Divergences in regulatory outcomes for simultaneous (within 91 days) submissions to both agencies were identified and then examined for use of facilitated regulatory pathways and orphan designations; submitted versus approved indications; and approval times.ResultsIn 2014–2016, 115 NASs were approved by EMA or FDA or both; 74/115 were new chemical entities and 41 new biological/biotechnology entities; 82/115 were approved by both agencies, 24 only by FDA and nine only by EMA. Simultaneous submission occurred for 52/115; 13/52 received expedited review by both agencies and 18 only by FDA; 8/52 received conditional approval from both agencies, 2/52 only from FDA and 1/52 only from EMA; 17/52 were designated as orphans by both agencies and 10/52 by FDA only; 31/52 indications were approved as submitted and 21 changed by EMA and 29/46 were approved as submitted (six not assessed) and 17/46 changed by FDA. Median FDA review timelines were 319 days compared with 409 days for EMA.ConclusionsThere was general agreement in EMA / FDA conditional approvals. FDA used expedited pathways and orphan designation more often than EMA, suggesting stricter EMA criteria or definitions for these designations or less flexible processes. Despite consistency in submitted indications, there was lack of concordance in approved indications, which should be further investigated. FDA review times are faster because of a wider range of expedited pathways and the two-step EMA process; this may change with recent revisions to EMA accelerated assessment guidelines and the launch of Priority Medicines.

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