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Google Keyword Rankings for : europe drugs approved
1
Medicines Approval system
https://www.hma.eu/about-hma/medicines-approval-system.html
The European Medicines Agency ( EMA ) organises the process of evaluation using scientific expertise from the Member States.
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https://www.hma.eu/about-hma/medicines-approval-system.html
The European Medicines Agency ( EMA ) organises the process of evaluation using scientific expertise from the Member States.
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2
Additional safety risk to exceptionally approved drugs ... - NCBI
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175519/
A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval.
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3175519/
A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval.
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3
Comparison of European and U.S. Approval Processes
https://www.sciencedirect.com/science/article/pii/S2452302X16300638
After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of ...
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https://www.sciencedirect.com/science/article/pii/S2452302X16300638
After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of ...
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4
retrospective cohort study of drug approvals 2009-13 - The BMJ
https://www.bmj.com/content/359/bmj.j4530
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: ...
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https://www.bmj.com/content/359/bmj.j4530
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: ...
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5
European Medicines Agency - Wikipedia
https://en.wikipedia.org/wiki/European_Medicines_Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products.
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https://en.wikipedia.org/wiki/European_Medicines_Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products.
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6
Availability of New Medicines in the US and Germany From ...
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2795755
In Germany, medicine availability reflects a 3-step process. First, for most new medicines, the EMA makes an approval decision for all European ...
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https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2795755
In Germany, medicine availability reflects a 3-step process. First, for most new medicines, the EMA makes an approval decision for all European ...
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7
New drug approvals in Europe & US during 2020 - NDA Group
https://ndareg.com/news/new-drug-approvals-in-europe-us-during-2020/
A record-breaking 133 new therapeutic drugs were approved across the EU and the US and the medical value in patient care of these new ...
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https://ndareg.com/news/new-drug-approvals-in-europe-us-during-2020/
A record-breaking 133 new therapeutic drugs were approved across the EU and the US and the medical value in patient care of these new ...
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8
Sanofi and AZ drugs nearing new approvals in Europe
https://www.fiercepharma.com/pharma/az-and-sanofi-win-big-europes-human-medicines-committee-endorses-15-drug-approvals
AstraZeneca and Sanofi were the biggest winners this time around, nabbing three and four approval recommendations, respectively. The EMA's Committee for ...
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https://www.fiercepharma.com/pharma/az-and-sanofi-win-big-europes-human-medicines-committee-endorses-15-drug-approvals
AstraZeneca and Sanofi were the biggest winners this time around, nabbing three and four approval recommendations, respectively. The EMA's Committee for ...
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9
European Medicines Agency (EMA) Definition - Investopedia
https://www.investopedia.com/terms/e/european-medicines-agency-ema.asp
European Medicines Agency (EMA) is a government entity that promotes access to and approval of medications in European countries.
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https://www.investopedia.com/terms/e/european-medicines-agency-ema.asp
European Medicines Agency (EMA) is a government entity that promotes access to and approval of medications in European countries.
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10
95% of new oncology drugs approved in US before Europe in ...
https://endpts.com/95-of-new-oncology-drugs-approved-in-us-before-europe-in-past-decade-study-finds/
From 2010 to 2019, 85 of 89 new cancer drugs, or 95% of therapies, were approved in the US first, compared to only four that got an OK from ...
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https://endpts.com/95-of-new-oncology-drugs-approved-in-us-before-europe-in-past-decade-study-finds/
From 2010 to 2019, 85 of 89 new cancer drugs, or 95% of therapies, were approved in the US first, compared to only four that got an OK from ...
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11
New Cancer Drugs Approved Faster in U.S. Than Europe
https://www.physiciansweekly.com/new-cancer-drugs-approved-faster-in-u-s-than-europe/
The researchers found that the FDA approved 85 oncology therapies (95 percent) before European authorization and four therapies after. In Europe ...
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https://www.physiciansweekly.com/new-cancer-drugs-approved-faster-in-u-s-than-europe/
The researchers found that the FDA approved 85 oncology therapies (95 percent) before European authorization and four therapies after. In Europe ...
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12
EMA drug approvals in 2022 | European Commission News
https://www.ipharmacenter.com/post/drug-approvals-in-europe-in-2022-ema-drug-approvals-in-2022
Find the drugs approved by the EMA in 2022. EMA approves drugs for whole of Europe European Commission approved Pfizer's Lorviqua for ALK-positive NSCLC.
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https://www.ipharmacenter.com/post/drug-approvals-in-europe-in-2022-ema-drug-approvals-in-2022
Find the drugs approved by the EMA in 2022. EMA approves drugs for whole of Europe European Commission approved Pfizer's Lorviqua for ALK-positive NSCLC.
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13
EU New Drug Approvals Hit Record High - Pink Sheet
https://pink.pharmaintelligence.informa.com/PS145520/EU-New-Drug-Approvals-Hit-Record-High
A record 52 medicines containing a new active substance (NAS) were authorized for marketing in the EU last year, driven in part by the approval ...
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https://pink.pharmaintelligence.informa.com/PS145520/EU-New-Drug-Approvals-Hit-Record-High
A record 52 medicines containing a new active substance (NAS) were authorized for marketing in the EU last year, driven in part by the approval ...
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14
Post‐Marketing Requirements for Cancer Drugs Approved by ...
https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2679?af=R
To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that ...
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https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2679?af=R
To address unresolved questions about drug safety and efficacy at the time of approval, the European Medicines Agency (EMA) may require that ...
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15
Bill Wants Drugs Approved in Europe to be Available More ...
https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2015/3/bill-wants-drugs-approved-in-europe-to-be-available-more-quickly-to-us-patients
New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite ...
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https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2015/3/bill-wants-drugs-approved-in-europe-to-be-available-more-quickly-to-us-patients
New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite ...
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16
New study shows 95% of new cancer drugs are approved in ...
https://www.imperial.ac.uk/news/237334/new-study-shows-95-cancer-drugs
Over the last decade, the US FDA is faster to approve new oncology therapies compared with the European EMA; but that speed may have ...
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https://www.imperial.ac.uk/news/237334/new-study-shows-95-cancer-drugs
Over the last decade, the US FDA is faster to approve new oncology therapies compared with the European EMA; but that speed may have ...
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17
EU 2021 | New Drug Approvals
https://newdrugapprovals.org/category/eu-2021/
Diroximel fumarate was approved for medical use in the United States in October 2019, and in the European Union in November 2021. History. This ...
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https://newdrugapprovals.org/category/eu-2021/
Diroximel fumarate was approved for medical use in the United States in October 2019, and in the European Union in November 2021. History. This ...
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18
Early market access of cancer drugs in the EU
https://www.annalsofoncology.org/article/S0923-7534(19)35358-X/fulltext
The European Medicines Agency (EMA) is responsible for providing a scientific ... The approval of new drugs in Europe is built on the benefit–risk (B/R) ...
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https://www.annalsofoncology.org/article/S0923-7534(19)35358-X/fulltext
The European Medicines Agency (EMA) is responsible for providing a scientific ... The approval of new drugs in Europe is built on the benefit–risk (B/R) ...
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19
Time to access to novel anticancer drugs in Europe, a case ...
https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.1586
In Germany, where there is no pricing and reimbursement approval required when launching a pharmaceutical, 100% of the cancer medicines are ...
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https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.16_suppl.1586
In Germany, where there is no pricing and reimbursement approval required when launching a pharmaceutical, 100% of the cancer medicines are ...
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20
Biosimilars approved in Europe
https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
› biosimilars › general › bio...
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https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
› biosimilars › general › bio...
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21
Oncologic orphan drugs approved in the EU – do clinical trial ...
https://ojrd.biomedcentral.com/track/pdf/10.1186/s13023-018-0900-9.pdf
Although both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) agreed that. OS is the most reliable and persuasive ...
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https://ojrd.biomedcentral.com/track/pdf/10.1186/s13023-018-0900-9.pdf
Although both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) agreed that. OS is the most reliable and persuasive ...
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22
Oncologic Drugs Approval in Europe for Solid Tumors - MDPI
https://www.mdpi.com/2072-6694/14/4/889/htm
A new indication was the first approval in Europe for a given medication. Extension of indication regarded medicines that are already available on the European ...
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https://www.mdpi.com/2072-6694/14/4/889/htm
A new indication was the first approval in Europe for a given medication. Extension of indication regarded medicines that are already available on the European ...
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23
Sanofi, Astra Drug Approved to Protect Infants from RSV in ...
https://www.bloomberg.com/news/articles/2022-11-04/sanofi-astra-drug-that-protects-infants-from-rsv-approved-in-europe
The approval was expected after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Beyfortus in ...
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https://www.bloomberg.com/news/articles/2022-11-04/sanofi-astra-drug-that-protects-infants-from-rsv-approved-in-europe
The approval was expected after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Beyfortus in ...
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24
Market approval for drugs in the EU: time to change direction?
https://link.springer.com/article/10.1007/s10198-016-0863-5
Since 1995, the European Medicines Agency (EMA) has been the European Union (EU) authority responsible for assessing the efficacy, ...
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https://link.springer.com/article/10.1007/s10198-016-0863-5
Since 1995, the European Medicines Agency (EMA) has been the European Union (EU) authority responsible for assessing the efficacy, ...
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25
Europe: EMA Medicine Approvals 2020 - PharmaBoardroom
https://pharmaboardroom.com/facts/europe-ema-medicine-approvals-2020/
The full list of medicines recommended for approval by the European Medicines Agency (EMA) in 2020 divided by therapeutic area and with ...
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https://pharmaboardroom.com/facts/europe-ema-medicine-approvals-2020/
The full list of medicines recommended for approval by the European Medicines Agency (EMA) in 2020 divided by therapeutic area and with ...
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26
The approval process of medicines in Europe
https://www.tandfonline.com/doi/pdf/10.1179/2047480614Z.000000000205
Abstract. The European system of approval of new medicines comprises an European Union (EU)-wide authoris- ation procedure (the so called centralised pro-.
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https://www.tandfonline.com/doi/pdf/10.1179/2047480614Z.000000000205
Abstract. The European system of approval of new medicines comprises an European Union (EU)-wide authoris- ation procedure (the so called centralised pro-.
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27
Shaping EU medicines regulation in the post COVID-19 era
https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00169-1/fulltext
The EMRN is the cornerstone of medicines' approval and supervision in the EU. The European Union (EU)-wide centralised authorisation ...
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https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00169-1/fulltext
The EMRN is the cornerstone of medicines' approval and supervision in the EU. The European Union (EU)-wide centralised authorisation ...
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28
Lists of medicinal products for rare diseases in Europe*
https://www.orpha.net/orphacom/cahiers/docs/GB/list_of_orphan_drugs_in_europe.pdf
the tab “Orphan drugs” on the Orphanet website www.orpha.net or on the EMA website (European. Medicines. Agency) http://www.ema.europa.eu.
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https://www.orpha.net/orphacom/cahiers/docs/GB/list_of_orphan_drugs_in_europe.pdf
the tab “Orphan drugs” on the Orphanet website www.orpha.net or on the EMA website (European. Medicines. Agency) http://www.ema.europa.eu.
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29
Approval of Cancer Drugs With Uncertain Therapeutic Value
https://www.jstor.org/stable/48602841
uncertain therapeutic value reviewed by both the US Food and Drug. Administration (FDA) and the European Medicines Agency (EMA), we.
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https://www.jstor.org/stable/48602841
uncertain therapeutic value reviewed by both the US Food and Drug. Administration (FDA) and the European Medicines Agency (EMA), we.
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30
EU: Possible virus drug approval 'before the summer' - AP News
https://apnews.com/article/virus-outbreak-health-clinical-trials-international-news-business-fe8f75efff861d04fa218af112168c60
LONDON (AP) — The European Medicines Agency predicted that there could be licensed drugs to treat the new coronavirus in the next few months ...
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https://apnews.com/article/virus-outbreak-health-clinical-trials-international-news-business-fe8f75efff861d04fa218af112168c60
LONDON (AP) — The European Medicines Agency predicted that there could be licensed drugs to treat the new coronavirus in the next few months ...
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31
Medicines For Europe | Better Access. Better Health
https://www.medicinesforeurope.com/
Medicines For Europe (formerly EGA) represents the European generic, biosimilar and valued added pharmaceutical industries.
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https://www.medicinesforeurope.com/
Medicines For Europe (formerly EGA) represents the European generic, biosimilar and valued added pharmaceutical industries.
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32
Tezspire approved in the EU for the treatment of severe asthma
https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html
The approval follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July ...
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https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-the-eu-for-the-treatment-of-severe-asthma.html
The approval follows the recommendation by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in July ...
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33
BfArM
http://www.bfarm.de/EN/Home/_node.html
The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency ...
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http://www.bfarm.de/EN/Home/_node.html
The BfArM is the largest drug approval authority in Europe. Experts contribute their knowledge to the scientific committees of the European Medicines Agency ...
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34
Achieving equal and timely access to innovative anticancer ...
https://www.esmoopen.com/article/S2059-7029(20)30086-7/fulltext
The approval process of drugs is well established and access delays can be ... In contrast, nearly 95% of all medicines newly authorised by the European ...
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https://www.esmoopen.com/article/S2059-7029(20)30086-7/fulltext
The approval process of drugs is well established and access delays can be ... In contrast, nearly 95% of all medicines newly authorised by the European ...
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35
List of the marketing authorisations - eurordis.org
https://www.eurordis.org/list-of-the-marketing-authorisations/
A full list of designated and authorised orphan medicinal products in Europe available at: ec.europa.eu. Orphan Drug Regulatory process in EU · Learn more about ...
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https://www.eurordis.org/list-of-the-marketing-authorisations/
A full list of designated and authorised orphan medicinal products in Europe available at: ec.europa.eu. Orphan Drug Regulatory process in EU · Learn more about ...
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36
Hurdles and delays in access to anti-cancer drugs in Europe
https://ecancer.org/en/journal/article/482-hurdles-and-delays-in-access-to-anti-cancer-drugs-in-europe
The drug approval rate has been relatively constant since implementing the centralized procedure: between 1997 and 2001 EMA approved 71% of all classes of drug ...
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https://ecancer.org/en/journal/article/482-hurdles-and-delays-in-access-to-anti-cancer-drugs-in-europe
The drug approval rate has been relatively constant since implementing the centralized procedure: between 1997 and 2001 EMA approved 71% of all classes of drug ...
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37
FDA approves drugs more quickly than peer agency in Europe
https://news.yale.edu/2017/04/05/fda-approves-drugs-more-quickly-peer-agency-europe
The researchers found that the FDA approved more new drugs than EMA — 170 versus 144 — in the study period. The median review time for FDA- ...
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https://news.yale.edu/2017/04/05/fda-approves-drugs-more-quickly-peer-agency-europe
The researchers found that the FDA approved more new drugs than EMA — 170 versus 144 — in the study period. The median review time for FDA- ...
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38
For treatment of some breast cancers, 2 drugs approved ... - Mint
https://www.livemint.com/science/news/for-treatment-of-some-breast-cancers-2-astrazeneca-drugs-approved-by-european-union-11656316100522.html
If approved by the European Commission, patients in Europe may be able to benefit from this important medicine earlier in the treatment of their ...
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https://www.livemint.com/science/news/for-treatment-of-some-breast-cancers-2-astrazeneca-drugs-approved-by-european-union-11656316100522.html
If approved by the European Commission, patients in Europe may be able to benefit from this important medicine earlier in the treatment of their ...
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39
Oncologic Drugs Approval in Europe for Solid Tumors - MDPI
https://mdpi-res.com/d_attachment/cancers/cancers-14-00889/article_deploy/cancers-14-00889.pdf?version=1644571355
The aim of the present study was to provide an insight into the features of anti-tumor drugs approved in Europe;. (2) Methods: We included all ...
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https://mdpi-res.com/d_attachment/cancers/cancers-14-00889/article_deploy/cancers-14-00889.pdf?version=1644571355
The aim of the present study was to provide an insight into the features of anti-tumor drugs approved in Europe;. (2) Methods: We included all ...
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40
UK approved fewer new drugs than EU and US in year after ...
https://www.theguardian.com/business/2022/jul/14/uk-approved-fewer-new-drugs-eu-us-year-after-brexit-transition
All novel medicines in the UK have to be vetted and approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) since the ...
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https://www.theguardian.com/business/2022/jul/14/uk-approved-fewer-new-drugs-eu-us-year-after-brexit-transition
All novel medicines in the UK have to be vetted and approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) since the ...
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41
EU regulator builds Omicron defences with approvals of GSK ...
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-okays-covid-19-treatments-gsk-vir-sobi-2021-12-16/
The approval by the European Medicines Agency (EMA) of GSK-Vir's antibody drug Xevudy and Sobi's arthritis drug Kineret come as governments ...
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https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-okays-covid-19-treatments-gsk-vir-sobi-2021-12-16/
The approval by the European Medicines Agency (EMA) of GSK-Vir's antibody drug Xevudy and Sobi's arthritis drug Kineret come as governments ...
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42
Mutual Recognition Agreement (MRA) - FDA
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra
FDA and the EU have collaborated since May 2014 to evaluate the ways in which each regulator inspects drug manufacturers and assesses the risk and benefits of ...
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https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra
FDA and the EU have collaborated since May 2014 to evaluate the ways in which each regulator inspects drug manufacturers and assesses the risk and benefits of ...
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43
How cancer drugs are licensed in the UK
https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/access-to-treatment/how-are-drugs-licensed-in-the-uk
Once a drug has EU marketing authorisation, it is 'licensed', 'registered' or 'approved'. All these terms mean the same thing. The EMA also check on the ...
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https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/access-to-treatment/how-are-drugs-licensed-in-the-uk
Once a drug has EU marketing authorisation, it is 'licensed', 'registered' or 'approved'. All these terms mean the same thing. The EMA also check on the ...
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44
List of Approved Products | Pharmaceuticals and Medical ...
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html
List of Approved Products. New Drugs. FY 2022 PDF(Open a new window) (April 2022 - August 2022); FY 2021 ...
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https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html
List of Approved Products. New Drugs. FY 2022 PDF(Open a new window) (April 2022 - August 2022); FY 2021 ...
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45
The FDA is approving cancer drugs faster than ... - STAT News
https://www.statnews.com/pharmalot/2022/06/13/fda-ema-cancer-oncology-accelerated-approval/
Of 89 new cancer medicines approved by both agencies between 2010 and 2019, the U.S. Food and Drug Administration sanctioned 85 of the ...
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https://www.statnews.com/pharmalot/2022/06/13/fda-ema-cancer-oncology-accelerated-approval/
Of 89 new cancer medicines approved by both agencies between 2010 and 2019, the U.S. Food and Drug Administration sanctioned 85 of the ...
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46
Oncology Drugs Lag Between Europe and other Countries
https://www.valueinhealthjournal.com/article/S1098-3015(16)01575-8/fulltext
Generally, oncology drugs approved by FDA. After that, they were approved by EMA, followed by HC, Swissmedic, and then TGA. The emergence of new regulations is ...
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https://www.valueinhealthjournal.com/article/S1098-3015(16)01575-8/fulltext
Generally, oncology drugs approved by FDA. After that, they were approved by EMA, followed by HC, Swissmedic, and then TGA. The emergence of new regulations is ...
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47
European Medicines Agency Validates ... - Bristol Myers Squibb
https://news.bms.com/news/details/2022/European-Medicines-Agency-Validates-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-with-Chemotherapy-as-Neoadjuvant-Treatment-for-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx
We look forward to working with the European Medicines Agency with the goal of achieving the first approval of a neoadjuvant ...
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https://news.bms.com/news/details/2022/European-Medicines-Agency-Validates-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-with-Chemotherapy-as-Neoadjuvant-Treatment-for-Resectable-Non-Small-Cell-Lung-Cancer/default.aspx
We look forward to working with the European Medicines Agency with the goal of achieving the first approval of a neoadjuvant ...
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48
Does fast-track drugs approval in EU run too fast?
https://www.euractiv.com/section/health-consumers/news/does-fast-track-drugs-approval-in-eu-run-too-fast/
Under the EU fast-track scheme, 83% of medicines approved concern rare disease and 44% are intended to treat pediatric patients. Hepatitis ...
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https://www.euractiv.com/section/health-consumers/news/does-fast-track-drugs-approval-in-eu-run-too-fast/
Under the EU fast-track scheme, 83% of medicines approved concern rare disease and 44% are intended to treat pediatric patients. Hepatitis ...
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49
If A Drug Is Good Enough For Europeans, It's ... - Health Affairs
https://www.healthaffairs.org/do/10.1377/forefront.20140214.037238
The natural question to ask is why the FDA shouldn't just approve a product already approved for the European Union, Canada, and Australia, ...
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https://www.healthaffairs.org/do/10.1377/forefront.20140214.037238
The natural question to ask is why the FDA shouldn't just approve a product already approved for the European Union, Canada, and Australia, ...
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50
Monitoring evidence on overall survival benefits of anticancer ...
https://www.ejcancer.com/article/S0959-8049(19)30004-8/fulltext
Identification of European Medicines Agency (EMA) approved cancer drugs with ambiguous benefit-risk profiles. •. Monitoring of postapproval ...
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https://www.ejcancer.com/article/S0959-8049(19)30004-8/fulltext
Identification of European Medicines Agency (EMA) approved cancer drugs with ambiguous benefit-risk profiles. •. Monitoring of postapproval ...
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51
Delayed EMA approval: improved safety or lack of access to ...
https://www.clinicaltrialsarena.com/comment/delayed-ema-approval/
A median delay of 241 days from US Food and Drug Administration (FDA) to European Medicines Agency (EMA) approval was reported for the 89 ...
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https://www.clinicaltrialsarena.com/comment/delayed-ema-approval/
A median delay of 241 days from US Food and Drug Administration (FDA) to European Medicines Agency (EMA) approval was reported for the 89 ...
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52
New Drug Approvals in the USA, Europe and Japan
https://www.genome.jp/kegg/drug/br08328.html
› kegg › drug
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https://www.genome.jp/kegg/drug/br08328.html
› kegg › drug
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53
Ten years of marketing approvals of anticancer drugs in Europe
https://www.nature.com/articles/6602750
First of all, the evaluation only pertains to anticancer drugs approved by EMEA following the centralised procedure and it must be borne in mind ...
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https://www.nature.com/articles/6602750
First of all, the evaluation only pertains to anticancer drugs approved by EMEA following the centralised procedure and it must be borne in mind ...
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54
The evidence base for psychotropic drugs approved by the ...
https://www.cambridge.org/core/journals/epidemiology-and-psychiatric-sciences/article/evidence-base-for-psychotropic-drugs-approved-by-the-european-medicines-agency-a-metaassessment-of-all-european-public-assessment-reports/0E227B258F07684DD6B33D548A22B00A
EPAR, European Public Assessment Report; O, oral route; IM, intramuscular; INH, inhalation. a These EPARs had no identifying number on EMA's ...
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https://www.cambridge.org/core/journals/epidemiology-and-psychiatric-sciences/article/evidence-base-for-psychotropic-drugs-approved-by-the-european-medicines-agency-a-metaassessment-of-all-european-public-assessment-reports/0E227B258F07684DD6B33D548A22B00A
EPAR, European Public Assessment Report; O, oral route; IM, intramuscular; INH, inhalation. a These EPARs had no identifying number on EMA's ...
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55
EU drug watchdog approves Pfizer's antiviral Covid-19 pill for ...
https://www.france24.com/en/europe/20220127-eu-s-drug-watchdog-conditionally-approves-pfizer-s-covid-19-pill
The European Medicines Agency (EMA) on January 27, 2022, conditionally approved Pfizer 01:27. The European Medicines Agency (EMA) on January 27, ...
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https://www.france24.com/en/europe/20220127-eu-s-drug-watchdog-conditionally-approves-pfizer-s-covid-19-pill
The European Medicines Agency (EMA) on January 27, 2022, conditionally approved Pfizer 01:27. The European Medicines Agency (EMA) on January 27, ...
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56
Why people should be able to buy drugs approved in other ...
https://www.washingtonpost.com/news/in-theory/wp/2017/02/14/why-people-should-be-able-to-buy-drugs-approved-in-other-countries/
Under reciprocity agreements, drugs that are approved in Europe or other developed countries such as Japan would also be approved for and ...
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https://www.washingtonpost.com/news/in-theory/wp/2017/02/14/why-people-should-be-able-to-buy-drugs-approved-in-other-countries/
Under reciprocity agreements, drugs that are approved in Europe or other developed countries such as Japan would also be approved for and ...
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57
Paediatric Medicines in Europe: The Paediatric Regulation ...
https://www.frontiersin.org/articles/10.3389/fmed.2021.593281/full
The remaining 47 were approved without an approved Paediatric Investigational Plan, following the provisions of Directive 2001/83/EC and ...
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https://www.frontiersin.org/articles/10.3389/fmed.2021.593281/full
The remaining 47 were approved without an approved Paediatric Investigational Plan, following the provisions of Directive 2001/83/EC and ...
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58
Drugs and Prescriptions in Europe
https://emanet.org/drugs-and-prescriptions-in-europe/
Today, medicinal products in the may be either authorised at EU level by the European Commission or at national level by Member States competent authorities ...
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https://emanet.org/drugs-and-prescriptions-in-europe/
Today, medicinal products in the may be either authorised at EU level by the European Commission or at national level by Member States competent authorities ...
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59
Cancer drugs approved faster in the United States than in ...
https://pharmaceutical-journal.com/article/news/cancer-drugs-approved-faster-in-the-united-states-than-in-europe-or-canada
In Europe, it took 6.0 months longer to approve such drugs and 7.6 months in Canada compared with the United States.
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https://pharmaceutical-journal.com/article/news/cancer-drugs-approved-faster-in-the-united-states-than-in-europe-or-canada
In Europe, it took 6.0 months longer to approve such drugs and 7.6 months in Canada compared with the United States.
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60
Baricitinib Backed for Approval for Alopecia Areata in the EU
https://www.medscape.com/viewarticle/974368
Baricitinib Recommended for Approval of Severe Alopecia Areata in Europe ... The European Medicines Agency's (EMA) Committee for Medicinal ...
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https://www.medscape.com/viewarticle/974368
Baricitinib Recommended for Approval of Severe Alopecia Areata in Europe ... The European Medicines Agency's (EMA) Committee for Medicinal ...
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61
CHMP recommends 13 new drugs for European approval
https://www.pharmaceutical-technology.com/analysis/chmp-orphan-drugs-ec-approval/
The EMA's CHMP has recommended 13 medicines, including three orphan drugs, for marketing approval by the European Commission.
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https://www.pharmaceutical-technology.com/analysis/chmp-orphan-drugs-ec-approval/
The EMA's CHMP has recommended 13 medicines, including three orphan drugs, for marketing approval by the European Commission.
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62
MEDICINES REIMBURSEMENT POLICIES IN EUROPE
https://www.euro.who.int/__data/assets/pdf_file/0011/376625/pharmaceutical-reimbursement-eng.pdf
Reimbursement of medicines in the WHO European Region ... In Norway, the MAH for a medicine can apply for pre-approved reimbursement so that physicians can ...
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https://www.euro.who.int/__data/assets/pdf_file/0011/376625/pharmaceutical-reimbursement-eng.pdf
Reimbursement of medicines in the WHO European Region ... In Norway, the MAH for a medicine can apply for pre-approved reimbursement so that physicians can ...
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63
The postcode lottery: Europe's access to medicines – POLITICO
https://www.politico.eu/article/postcode-lottery-europe-access-medicine/
Medicines for cancer or heart disease are approved for use throughout Europe, but that doesn't mean all patients can access them — and the EU is ...
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https://www.politico.eu/article/postcode-lottery-europe-access-medicine/
Medicines for cancer or heart disease are approved for use throughout Europe, but that doesn't mean all patients can access them — and the EU is ...
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64
Approved Medicines - PTC Therapeutics
https://www.ptcbio.com/our-pipeline/approved-medicines/
TRANSLARNA™ (ataluren)* has been approved in the European Union and Brazil for ambulatory patients aged 2 years and older with Duchenne muscular dystrophy ...
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https://www.ptcbio.com/our-pipeline/approved-medicines/
TRANSLARNA™ (ataluren)* has been approved in the European Union and Brazil for ambulatory patients aged 2 years and older with Duchenne muscular dystrophy ...
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65
A comparison with standard approved cancer drugs
https://www.researchgate.net/publication/356216952_Pre-approval_and_post-approval_availability_of_evidence_and_clinical_benefit_of_conditionally_approved_cancer_drugs_in_Europe_A_comparison_with_standard_approved_cancer_drugs
PDF | Aim: Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing ...
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https://www.researchgate.net/publication/356216952_Pre-approval_and_post-approval_availability_of_evidence_and_clinical_benefit_of_conditionally_approved_cancer_drugs_in_Europe_A_comparison_with_standard_approved_cancer_drugs
PDF | Aim: Cancer drugs are increasingly approved through expedited regulatory pathways including the European conditional marketing ...
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66
EU Medicines Agency (@EMA_News) / Twitter
https://twitter.com/ema_news
Latest news from the European Medicines Agency, the European Union agency responsible for the evaluation and supervision of medicines. RTs ≠ endorsement.
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https://twitter.com/ema_news
Latest news from the European Medicines Agency, the European Union agency responsible for the evaluation and supervision of medicines. RTs ≠ endorsement.
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67
Myths, questions, facts about generic drugs in the EU
http://gabi-journal.net/myths-questions-facts-about-generic-drugs-in-the-eu.html
They are strictly regulated by the National and European Competent Authorities and they are only granted approval by going through an extensive authorisation ...
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http://gabi-journal.net/myths-questions-facts-about-generic-drugs-in-the-eu.html
They are strictly regulated by the National and European Competent Authorities and they are only granted approval by going through an extensive authorisation ...
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68
A Comparison of EMA and FDA Decisions for New Drug ...
https://www.vbb.com/media/Insights_Newsletters/Kashoki_et_al_2019_Clinical_Pharmacology___Therapeutics.pdf
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have ... Divergence in approval decisions, type of approval, and approved ...
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https://www.vbb.com/media/Insights_Newsletters/Kashoki_et_al_2019_Clinical_Pharmacology___Therapeutics.pdf
The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have ... Divergence in approval decisions, type of approval, and approved ...
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69
Europe surpasses United States in new drug discoveries
https://news.stanford.edu/pr/2009/pr-light-pharma-study-082109.html
Americans somehow believe that a new drug must be better; otherwise it wouldn't have been approved," Light said. "European buying groups ...
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https://news.stanford.edu/pr/2009/pr-light-pharma-study-082109.html
Americans somehow believe that a new drug must be better; otherwise it wouldn't have been approved," Light said. "European buying groups ...
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70
Clinical Trials in the European Union - EMA
https://euclinicaltrials.eu/
A clinical trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human ...
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https://euclinicaltrials.eu/
A clinical trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human ...
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71
3 Common U.S. Drugs Outlawed In Europe | MedTruth
https://medtruth.com/articles/fda-regulation/fda-ema-american-drugs-outlawed-in-europe/
The European Medicines Agency strictly regulates medications and consumer products. Americans taking popular drugs, such as Avandia, may not realize there ...
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https://medtruth.com/articles/fda-regulation/fda-ema-american-drugs-outlawed-in-europe/
The European Medicines Agency strictly regulates medications and consumer products. Americans taking popular drugs, such as Avandia, may not realize there ...
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72
EU recommends withdrawing drugs approved on unreliable ...
https://www.chemistryworld.com/news/eu-recommends-withdrawing-drugs-approved-on-unreliable-data/3007019.article
The recommendation, which will be passed to the European Commission for a legally binding decision, covers products from large and small ...
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https://www.chemistryworld.com/news/eu-recommends-withdrawing-drugs-approved-on-unreliable-data/3007019.article
The recommendation, which will be passed to the European Commission for a legally binding decision, covers products from large and small ...
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73
The root cause of unavailability and delay to innovative ...
https://www.efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
noted that there are non-centrally approved medicines for which many of these root causes ... “Hurdles and delays in access to anticancer drugs in Europe,” ...
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https://www.efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
noted that there are non-centrally approved medicines for which many of these root causes ... “Hurdles and delays in access to anticancer drugs in Europe,” ...
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74
Medicines and Healthcare products Regulatory Agency
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Second Pfizer/BioNTech bivalent COVID-19 booster vaccine approved by UK medicines regulator. 9 November 2022 — News story. This adapted COVID-19 vaccine targets ...
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https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
Second Pfizer/BioNTech bivalent COVID-19 booster vaccine approved by UK medicines regulator. 9 November 2022 — News story. This adapted COVID-19 vaccine targets ...
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75
Accessing unapproved drugs - Information Sheet H
https://www.mndassociation.org/app/uploads/2022/06/H-Accessing-unapproved-drugs.pdf
access drugs that don't yet have regulatory approval, assuming they will be approved ... Committee of the European Medicines Agency (EMA).
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https://www.mndassociation.org/app/uploads/2022/06/H-Accessing-unapproved-drugs.pdf
access drugs that don't yet have regulatory approval, assuming they will be approved ... Committee of the European Medicines Agency (EMA).
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76
Press Releases - Gilead Sciences
https://www.gilead.com/news-and-press/press-room/press-releases/2022/8/gilead-announces-first-global-regulatory-approval-of-sunlenca-lenacapavir-the-only-twiceyearly-hiv-treatment-option
Sunlenca is a first-in-class, long-acting HIV capsid inhibitor approved in the European Union for the treatment of HIV infection, in combination ...
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https://www.gilead.com/news-and-press/press-room/press-releases/2022/8/gilead-announces-first-global-regulatory-approval-of-sunlenca-lenacapavir-the-only-twiceyearly-hiv-treatment-option
Sunlenca is a first-in-class, long-acting HIV capsid inhibitor approved in the European Union for the treatment of HIV infection, in combination ...
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77
The new EU-wide HTA for innovative drugs | EUCOPE AISBL
https://www.eucope.org/events/the-new-eu-wide-health-technology-assessment-for-innovative-drugs/
In the European Union, drug approval has long been centrally regulated: EMA approval applies to the entire EU. Health Technology Assessment ...
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https://www.eucope.org/events/the-new-eu-wide-health-technology-assessment-for-innovative-drugs/
In the European Union, drug approval has long been centrally regulated: EMA approval applies to the entire EU. Health Technology Assessment ...
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78
EU Clinical Trials Register - Update
https://www.clinicaltrialsregister.eu/
The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area.
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https://www.clinicaltrialsregister.eu/
The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area.
→ Check Latest Keyword Rankings ←
79
Amid spike in cases, EU to shortly approve first Covid antibody ...
https://cyprus-mail.com/2021/11/09/amid-spike-in-cases-eu-to-shortly-approve-first-covid-antibody-drugs/
The European Union drugs regulator is set to authorise the use of two monoclonal antibodies to treat COVID-19 patients in coming days, ...
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https://cyprus-mail.com/2021/11/09/amid-spike-in-cases-eu-to-shortly-approve-first-covid-antibody-drugs/
The European Union drugs regulator is set to authorise the use of two monoclonal antibodies to treat COVID-19 patients in coming days, ...
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80
The European Medicines Agency (EMA) publishes list of ...
https://epha.org/the-european-medicines-agency-ema-publishes-list-of-drugs-under-additional-monitoring/
Medicines that are subject to additional monitoring are: – medicines authorised after 1 January 2011 that contain a new active substance; – ...
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https://epha.org/the-european-medicines-agency-ema-publishes-list-of-drugs-under-additional-monitoring/
Medicines that are subject to additional monitoring are: – medicines authorised after 1 January 2011 that contain a new active substance; – ...
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81
Drugs approved by EMA in 2019 | News
https://www.cambridgemedchemconsulting.com/news/index_files/c14a5b26ad3e8106df1ed66507a64b7a-407.html
However this turns out to be less straight-forward, medicines can be authorised in several European countries simultaneously by using one of three ...
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https://www.cambridgemedchemconsulting.com/news/index_files/c14a5b26ad3e8106df1ed66507a64b7a-407.html
However this turns out to be less straight-forward, medicines can be authorised in several European countries simultaneously by using one of three ...
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82
European Medicines Agency's Advisory Committee Backs ...
https://www.yahoo.com/now/european-medicines-agencys-advisory-committee-131522282.html
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approving AstraZeneca Plc ...
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https://www.yahoo.com/now/european-medicines-agencys-advisory-committee-131522282.html
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approving AstraZeneca Plc ...
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83
2. Drug approval and benefit assessment in other countries
https://www.iqwig.de/en/presse/in-the-focus/new-drugs-approval-benefit-assessment-coverage/2-drug-approval-and-benefit-assessment-in-other-countries/
In other EU countries, but also in further countries such as the USA , the requirements of the approval process are very similar in many areas: A new drug ...
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https://www.iqwig.de/en/presse/in-the-focus/new-drugs-approval-benefit-assessment-coverage/2-drug-approval-and-benefit-assessment-in-other-countries/
In other EU countries, but also in further countries such as the USA , the requirements of the approval process are very similar in many areas: A new drug ...
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84
Introduction to the EU Regulatory Submission Timeline | Almac
https://www.almacgroup.com/wp-content/uploads/2019/09/Introduction-to-the-EU-regulatory-submission-timeline-David-McCoubrey.pdf
3) EU Orphan Medicinal Product Designations ... One application assessed by the European Medicines ... EU equivalent of 'Accelerated Approval Program'.
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https://www.almacgroup.com/wp-content/uploads/2019/09/Introduction-to-the-EU-regulatory-submission-timeline-David-McCoubrey.pdf
3) EU Orphan Medicinal Product Designations ... One application assessed by the European Medicines ... EU equivalent of 'Accelerated Approval Program'.
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85
Does Europe Have A Pathway For Approval Of Drugs ...
https://premierconsulting.com/resources/blog/does-europe-have-a-pathway-for-approval-of-drugs-analogous-to-the-fdas-505b2-pathway/
Drugs approved through either the FDA 505(b)(2) pathway or the EMEA hybrid procedure cannot be marketed until the protection period (patent or ...
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https://premierconsulting.com/resources/blog/does-europe-have-a-pathway-for-approval-of-drugs-analogous-to-the-fdas-505b2-pathway/
Drugs approved through either the FDA 505(b)(2) pathway or the EMEA hybrid procedure cannot be marketed until the protection period (patent or ...
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86
retrospective cohort study of drug approvals 2009-13
http://eprints.lse.ac.uk/84606/
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: ...
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http://eprints.lse.ac.uk/84606/
Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: ...
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87
EU's CHMP recommends three new medicines for marketing ...
https://ihsmarkit.com/country-industry-forecasting.html?id=1065991626
Three new drugs have been recommended for approval in the European Union by the European Medicines Agency's Committee for Medicinal Products ...
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https://ihsmarkit.com/country-industry-forecasting.html?id=1065991626
Three new drugs have been recommended for approval in the European Union by the European Medicines Agency's Committee for Medicinal Products ...
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88
EU Exit - Frequently Asked Questions | Department of Health
https://www.health-ni.gov.uk/eu-exit-frequently-asked-questions
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided ... The UK will unilaterally recognise CE marked EU devices approved by EU ...
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https://www.health-ni.gov.uk/eu-exit-frequently-asked-questions
The Medicines and Healthcare products Regulatory Agency (MHRA) has provided ... The UK will unilaterally recognise CE marked EU devices approved by EU ...
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89
EU and US variation requirements - TOPRA
https://www.topra.org/topra/topra_member/pdfs/Lifecycle%20CPD%20-%20Jan%202017.pdf
Post-approval changes in the US. Changes to products licensed by the US FDA are achieved via the provision of supplements to the original new drug ...
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https://www.topra.org/topra/topra_member/pdfs/Lifecycle%20CPD%20-%20Jan%202017.pdf
Post-approval changes in the US. Changes to products licensed by the US FDA are achieved via the provision of supplements to the original new drug ...
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90
European approval in new heart failure indication | Press
https://www.boehringer-ingelheim.com/human-health/heart-diseases/heart-failure/preserved-heart-failure-treatment-approval-europe
Jardiance® (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless ...
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https://www.boehringer-ingelheim.com/human-health/heart-diseases/heart-failure/preserved-heart-failure-treatment-approval-europe
Jardiance® (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless ...
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91
Our Approved Medicines - Vertex Pharmaceuticals
https://www.vrtx.com/medicines/our-approved-medicines
SYMKEVI® (tezacaftor/ivacaftor) + KALYDECO® (ivacaftor) · European Union · European Union · Iceland · Iceland · Liechtenstein · Liechtenstein · Norway · Norway.
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https://www.vrtx.com/medicines/our-approved-medicines
SYMKEVI® (tezacaftor/ivacaftor) + KALYDECO® (ivacaftor) · European Union · European Union · Iceland · Iceland · Liechtenstein · Liechtenstein · Norway · Norway.
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92
Joint clinical assessment in the EU: Pan-European HTA for ...
https://www.xcenda.com/insights/htaq-spring-2022-joint-clinical-assessment-eu
With the new European Union (EU) Health Technology Assessment (HTA) regulation coming into force in January 2022, the transition phase to a ...
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https://www.xcenda.com/insights/htaq-spring-2022-joint-clinical-assessment-eu
With the new European Union (EU) Health Technology Assessment (HTA) regulation coming into force in January 2022, the transition phase to a ...
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93
Category:EMA approved drugs - A Hematology Oncology Wiki
https://hemonc.org/wiki/Category:EMA_approved_drugs
Drugs approved by the European Medicines Agency (EMA). For now, this category will mostly focus on drugs that are NOT FDA approved, ...
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https://hemonc.org/wiki/Category:EMA_approved_drugs
Drugs approved by the European Medicines Agency (EMA). For now, this category will mostly focus on drugs that are NOT FDA approved, ...
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94
Galapagos' Arthritis Drug Approved in EU and Japan Amid US ...
https://www.labiotech.eu/trends-news/galapagos-gilead-ema-fda/
The recent EU and Japan approvals of the rheumatoid arthritis drug filgotinib contrast with the FDA's rejection in August.
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https://www.labiotech.eu/trends-news/galapagos-gilead-ema-fda/
The recent EU and Japan approvals of the rheumatoid arthritis drug filgotinib contrast with the FDA's rejection in August.
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95
About emc - electronic medicines compendium (emc)
https://www.medicines.org.uk/emc/about-the-emc
emc has more than 14,000 documents, all of which have been checked and approved by either the UK or European government agencies which license medicines. These ...
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https://www.medicines.org.uk/emc/about-the-emc
emc has more than 14,000 documents, all of which have been checked and approved by either the UK or European government agencies which license medicines. These ...
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