European Medicines Agency (English Wikipedia)

"Members & Observers". International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Archived from the original on 24 April 2022. Retrieved 17 September 2023.
"Members & Observers". International Pharmaceutical Regulators Programme. Archived from the original on 24 April 2022. Retrieved 17 September 2023.
"Coronavirus disease (COVID-19)". European Medicines Agency. 29 January 2020. Archived from the original on 22 September 2021. Retrieved 16 September 2023.
"ACTIV". National Institutes of Health (NIH). Archived from the original on 11 January 2022. Retrieved 16 September 2023.

bmj.com

Tinari, Serena (10 March 2021). "The EMA covid-19 data leak, and what it tells us about mRNA instability". BMJ. 372: n627. doi:10.1136/bmj.n627. ISSN 1756-1833. PMID 33692030. Archived from the original on 16 September 2023. Retrieved 16 September 2023.

cepi.net

"Who we are". Coalition for Epidemic Preparedness Innovations. Archived from the original on 19 October 2022. Retrieved 16 September 2023.

cochrane.org

nordic.cochrane.org

"Complaint filed to the European Medicines Agency over maladministration related to safety of the HPV vaccines". Cochrane Nordic. 2017. Archived from the original on 31 August 2017. Retrieved 16 January 2021.

doi.org

M. Jacobs, David (2015). "European Medicines Agency (EMA)". Encyclopedia of Pharmaceutical Science and Technology (4 ed.). pp. 1449–1460. doi:10.1081/E-EPT4-120050267. ISBN 9781351124874. Archived from the original on 26 December 2022. Retrieved 26 December 2022.
Tinari, Serena (10 March 2021). "The EMA covid-19 data leak, and what it tells us about mRNA instability". BMJ. 372: n627. doi:10.1136/bmj.n627. ISSN 1756-1833. PMID 33692030. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Abbasi, Jennifer (13 April 2021). "Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups". JAMA. 325 (14): 1385. doi:10.1001/jama.2021.5002. ISSN 0098-7484. PMID 33847730.

euractiv.com

Morgan, Sam (23 March 2017). "Romania looks to poach EU medicines agency from UK". Euractiv. Archived from the original on 30 April 2017. Retrieved 8 May 2017.
"Strasbourg could trade Parliament seat for medicines agency". Reuters. 10 May 2017. Archived from the original on 22 November 2022. Retrieved 26 December 2022 – via Euractiv.

europa.eu

ema.europa.eu

"Relocation to Amsterdam". European Medicines Agency. 17 September 2018. Archived from the original on 15 October 2019. Retrieved 16 January 2021.
"Funding | European Medicines Agency (EMA)" (PDF). European Medicines Agency. 8 January 2024. Archived (PDF) from the original on 26 March 2024. Retrieved 26 March 2024.
Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (see communication on new visual identity Archived 1 June 2010 at the Wayback Machine and logo Archived 25 December 2009 at the Wayback Machine).
Hrabovszki, Georgina (11 March 2019). "EMA now operating from Amsterdam". European Medicines Agency. Archived from the original on 16 October 2019. Retrieved 12 March 2019.
"United Kingdom's withdrawal from the European Union ('Brexit')". European Medicines Agency. 17 September 2018. Archived from the original on 15 September 2019. Retrieved 16 September 2019.
"Committee for Medicinal Products Human Use (CHMP)". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 15 August 2022. Retrieved 26 July 2020.
"Questions and answers on the paediatric use marketing authorisation (PUMA)" (PDF). European Medicines Agency (EMA). 13 September 2011. Archived from the original (PDF) on 15 April 2016.
"The evaluation of medicines, step-by-step". European Medicines Agency (EMA). 25 November 2023. Archived from the original on 25 November 2023. Retrieved 25 November 2023.
"Committee for Medicinal Products Veterinary Use (CVMP)". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 27 May 2021. Retrieved 26 July 2020.
"Orphan designation: Overview". European Medicines Agency. 17 September 2018. Archived from the original on 26 December 2022. Retrieved 26 December 2022.
"Herbal medicinal products". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 June 2018. Retrieved 26 December 2022.
"Paediatric Regulation". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 26 December 2022. Retrieved 26 December 2022.
European Medicines Agency (3 December 2019). "Committee for Advanced Therapies (CAT)". European Medicines Agency. Archived from the original on 10 December 2019. Retrieved 3 December 2019.
European Medicines Agency (3 December 2019). "Pharmacovigilance Risk Assessment Committee (PRAC)". European Medicines Agency. Archived from the original on 11 October 2021. Retrieved 3 December 2019.
"Marketing authorisation". European Medicines Agency. 17 September 2018. Archived from the original on 3 May 2021. Retrieved 23 March 2021.
"Coronavirus disease (COVID-19)". European Medicines Agency. 29 January 2020. Archived from the original on 22 September 2021. Retrieved 16 September 2023.
"Cyberattack on EMA – update 5". European Medicines Agency. 15 January 2021. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Committee for Medicinal Products for Human Use (CHMP) (19 February 2021). "European public assessment report (EPAR) – Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified)" (PDF). European Medicines Agency. Archived (PDF) from the original on 12 September 2023. Retrieved 16 September 2023.

consilium.europa.eu

"Offers to host the European Medicines Agency (EMA)". European Council. Archived from the original on 13 December 2017. Retrieved 14 September 2017.
"Offers to host the European Medicines Agency (EMA)". European Council. Archived from the original on 6 August 2017. Retrieved 10 August 2017.

europa.eu

"European Medicines Agency (EMA) | European Union". europa.eu. 26 February 2020. Archived from the original on 8 April 2019. Retrieved 26 February 2020.

fda.gov

Sherwood, Ted (16 April 2008). "Generic Drugs: Overview of ANDA Review Process" (PDF). Food and Drug Administration. Archived from the original (PDF) on 19 January 2017. Retrieved 30 January 2010.

fiercepharma.com

Kansteiner, Fraser (15 March 2021). "Pfizer's COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report". Fierce Pharma. Archived from the original on 10 July 2023. Retrieved 16 September 2023.

ft.dk

Louise Brinth: Responsum to Assessment Report on HPV-vaccines released by EMA November 26th 2015., online (PDF; 1,3 MB) Archived 7 July 2016 at the Wayback Machine

ghostarchive.org

Julia Bradshaw (8 December 2016). "Sweden launches campaign to host EU drugs agency instead of UK after Brexit". The Telegraph. Archived from the original on 12 January 2022. Retrieved 1 April 2017.

global-counsel.co.uk

"A Brexit pill for Romania". Global Counsel UK. 13 April 2017. Archived from the original on 11 August 2017. Retrieved 8 May 2017.

hl7.org

"Benefactors of Health Level Seven". Health Level Seven International. Archived from the original on 1 June 2023. Retrieved 17 September 2023.

ich.org

"Members & Observers". International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Archived from the original on 24 April 2022. Retrieved 17 September 2023.

independent.co.uk

Lovett, Samuel (11 March 2021). "European regulator raised concern over quality of early Pfizer vaccine batches, leaked emails show". The Independent. Archived from the original on 16 September 2023. Retrieved 16 September 2023.

iprp.global

"Members & Observers". International Pharmaceutical Regulators Programme. Archived from the original on 24 April 2022. Retrieved 17 September 2023.

nature.com

Vesper, Inga (12 October 2017). "European drug regulation at risk of stalling as agency prepares to leave London". Nature News. Archived from the original on 17 May 2022. Retrieved 13 October 2017.

netherlandsforema.eu

"Homepage – The Dutch Bid for EMA". The Dutch Bid for EMA. Archived from the original on 14 July 2017. Retrieved 13 July 2017.

nih.gov

pubmed.ncbi.nlm.nih.gov

Tinari, Serena (10 March 2021). "The EMA covid-19 data leak, and what it tells us about mRNA instability". BMJ. 372: n627. doi:10.1136/bmj.n627. ISSN 1756-1833. PMID 33692030. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Abbasi, Jennifer (13 April 2021). "Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups". JAMA. 325 (14): 1385. doi:10.1001/jama.2021.5002. ISSN 0098-7484. PMID 33847730.

nih.gov

"ACTIV". National Institutes of Health (NIH). Archived from the original on 11 January 2022. Retrieved 16 September 2023.

pfizer.com

"Statement on EMA Cyberattack". Pfizer. 9 December 2020. Archived from the original on 16 September 2023. Retrieved 16 September 2023.

pharmatimes.com

Underwood, George (27 September 2017). "EMA staff favour move to Amsterdam". Pharma Times. Archived from the original on 5 October 2017. Retrieved 19 October 2017.

pmlive.com

"EMEA becomes EMA". PMLive. 14 December 2009. Archived from the original on 22 November 2022. Retrieved 6 October 2017.

repubblica.it

Bocci, Michele (20 November 2017). "Ema, Milano passa al secondo turno di votazioni con Amsterdam e Copenhagen" [Ema, Milan passes second in terms of votes with Amsterdam and Copenhangen]. la Repubblica (in Italian). Archived from the original on 9 November 2020. Retrieved 20 October 2017.

reuters.com

uk.reuters.com

"Reuters – Twenty-one countries vie to host EU drug agency after Brexit". Reuters. 10 April 2017. Archived from the original on 11 August 2017. Retrieved 10 August 2017.

reuters.com

Stubbs, Jack (9 December 2020). "Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say". Reuters. Archived from the original on 16 September 2023. Retrieved 16 September 2023.

sitcancer.org

"Cancer Immunotherapy Partnerships and Collaborations". Society for Immunotherapy of Cancer. Archived from the original on 27 March 2023. Retrieved 17 September 2023.

stm.fi

"Finland is an excellent place for European Medicines Agency". Ministry of Social Affairs and Health. 12 April 2017. Archived from the original on 18 April 2021. Retrieved 18 April 2017.

taylorfrancis.com

M. Jacobs, David (2015). "European Medicines Agency (EMA)". Encyclopedia of Pharmaceutical Science and Technology (4 ed.). pp. 1449–1460. doi:10.1081/E-EPT4-120050267. ISBN 9781351124874. Archived from the original on 26 December 2022. Retrieved 26 December 2022.

telegraph.co.uk

Julia Bradshaw (8 December 2016). "Sweden launches campaign to host EU drugs agency instead of UK after Brexit". The Telegraph. Archived from the original on 12 January 2022. Retrieved 1 April 2017.

theguardian.com

Wintour, Patrick (15 February 2017). "Countries line up to host European Medicines Agency after it leaves UK". The Guardian. Archived from the original on 1 April 2017. Retrieved 1 April 2017.
Wintour, Patrick (15 February 2017). "Countries line up to host European Medicines Agency after it leaves UK". The Guardian. Archived from the original on 29 April 2017. Retrieved 8 May 2017.

tportal.hr

Zapcic, Andreja (29 March 2017). "Kujundžić: Hrvatska je spremna preuzeti Europsku agenciju za lijekove" [Kujundžić: Croatia Is Ready to Take Over the European Medicines Agency] (in Croatian). T-portal. Archived from the original on 29 March 2017. Retrieved 1 April 2017.

vaccineconfidence.org

"Partnerships". Vaccine Confidence Project. Archived from the original on 28 April 2022. Retrieved 17 September 2023.

web.archive.org

"Relocation to Amsterdam". European Medicines Agency. 17 September 2018. Archived from the original on 15 October 2019. Retrieved 16 January 2021.
"European Medicines Agency (EMA) | European Union". europa.eu. 26 February 2020. Archived from the original on 8 April 2019. Retrieved 26 February 2020.
"Funding | European Medicines Agency (EMA)" (PDF). European Medicines Agency. 8 January 2024. Archived (PDF) from the original on 26 March 2024. Retrieved 26 March 2024.
Set up by EC Regulation No. 2309/93 as the European Agency for the Evaluation of Medicinal Products, and renamed by EC Regulation No. 726/2004 to the European Medicines Agency, it had the acronym EMEA until December 2009. The European Medicines Agency does not call itself EMA either – it has no official acronym but may reconsider if EMA becomes commonly accepted (see communication on new visual identity Archived 1 June 2010 at the Wayback Machine and logo Archived 25 December 2009 at the Wayback Machine).
"EMEA becomes EMA". PMLive. 14 December 2009. Archived from the original on 22 November 2022. Retrieved 6 October 2017.
Hrabovszki, Georgina (11 March 2019). "EMA now operating from Amsterdam". European Medicines Agency. Archived from the original on 16 October 2019. Retrieved 12 March 2019.
"United Kingdom's withdrawal from the European Union ('Brexit')". European Medicines Agency. 17 September 2018. Archived from the original on 15 September 2019. Retrieved 16 September 2019.
M. Jacobs, David (2015). "European Medicines Agency (EMA)". Encyclopedia of Pharmaceutical Science and Technology (4 ed.). pp. 1449–1460. doi:10.1081/E-EPT4-120050267. ISBN 9781351124874. Archived from the original on 26 December 2022. Retrieved 26 December 2022.
"Who we are". Coalition for Epidemic Preparedness Innovations. Archived from the original on 19 October 2022. Retrieved 16 September 2023.
"Benefactors of Health Level Seven". Health Level Seven International. Archived from the original on 1 June 2023. Retrieved 17 September 2023.
"Cancer Immunotherapy Partnerships and Collaborations". Society for Immunotherapy of Cancer. Archived from the original on 27 March 2023. Retrieved 17 September 2023.
"Partnerships". Vaccine Confidence Project. Archived from the original on 28 April 2022. Retrieved 17 September 2023.
"Committee for Medicinal Products Human Use (CHMP)". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 15 August 2022. Retrieved 26 July 2020.
"Questions and answers on the paediatric use marketing authorisation (PUMA)" (PDF). European Medicines Agency (EMA). 13 September 2011. Archived from the original (PDF) on 15 April 2016.
"The evaluation of medicines, step-by-step". European Medicines Agency (EMA). 25 November 2023. Archived from the original on 25 November 2023. Retrieved 25 November 2023.
"Complaint filed to the European Medicines Agency over maladministration related to safety of the HPV vaccines". Cochrane Nordic. 2017. Archived from the original on 31 August 2017. Retrieved 16 January 2021.
Louise Brinth: Responsum to Assessment Report on HPV-vaccines released by EMA November 26th 2015., online (PDF; 1,3 MB) Archived 7 July 2016 at the Wayback Machine
"Committee for Medicinal Products Veterinary Use (CVMP)". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 27 May 2021. Retrieved 26 July 2020.
"Orphan designation: Overview". European Medicines Agency. 17 September 2018. Archived from the original on 26 December 2022. Retrieved 26 December 2022.
"Herbal medicinal products". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 30 June 2018. Retrieved 26 December 2022.
"Paediatric Regulation". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 26 December 2022. Retrieved 26 December 2022.
European Medicines Agency (3 December 2019). "Committee for Advanced Therapies (CAT)". European Medicines Agency. Archived from the original on 10 December 2019. Retrieved 3 December 2019.
European Medicines Agency (3 December 2019). "Pharmacovigilance Risk Assessment Committee (PRAC)". European Medicines Agency. Archived from the original on 11 October 2021. Retrieved 3 December 2019.
"Marketing authorisation". European Medicines Agency. 17 September 2018. Archived from the original on 3 May 2021. Retrieved 23 March 2021.
"Annex 5: Countries and Organizations that Contributed to the Elaboration of the GVAP" (PDF). World Health Organization. Decade of Vaccines Collaboration. Archived (PDF) from the original on 17 September 2023. Retrieved 17 September 2023.
"Offers to host the European Medicines Agency (EMA)". European Council. Archived from the original on 13 December 2017. Retrieved 14 September 2017.
"Reuters – Twenty-one countries vie to host EU drug agency after Brexit". Reuters. 10 April 2017. Archived from the original on 11 August 2017. Retrieved 10 August 2017.
"Offers to host the European Medicines Agency (EMA)". European Council. Archived from the original on 6 August 2017. Retrieved 10 August 2017.
"Finland is an excellent place for European Medicines Agency". Ministry of Social Affairs and Health. 12 April 2017. Archived from the original on 18 April 2021. Retrieved 18 April 2017.
Wintour, Patrick (15 February 2017). "Countries line up to host European Medicines Agency after it leaves UK". The Guardian. Archived from the original on 1 April 2017. Retrieved 1 April 2017.
"Homepage – The Dutch Bid for EMA". The Dutch Bid for EMA. Archived from the original on 14 July 2017. Retrieved 13 July 2017.
Wintour, Patrick (15 February 2017). "Countries line up to host European Medicines Agency after it leaves UK". The Guardian. Archived from the original on 29 April 2017. Retrieved 8 May 2017.
Morgan, Sam (23 March 2017). "Romania looks to poach EU medicines agency from UK". Euractiv. Archived from the original on 30 April 2017. Retrieved 8 May 2017.
"A Brexit pill for Romania". Global Counsel UK. 13 April 2017. Archived from the original on 11 August 2017. Retrieved 8 May 2017.
Zapcic, Andreja (29 March 2017). "Kujundžić: Hrvatska je spremna preuzeti Europsku agenciju za lijekove" [Kujundžić: Croatia Is Ready to Take Over the European Medicines Agency] (in Croatian). T-portal. Archived from the original on 29 March 2017. Retrieved 1 April 2017.
"Strasbourg could trade Parliament seat for medicines agency". Reuters. 10 May 2017. Archived from the original on 22 November 2022. Retrieved 26 December 2022 – via Euractiv.
Underwood, George (27 September 2017). "EMA staff favour move to Amsterdam". Pharma Times. Archived from the original on 5 October 2017. Retrieved 19 October 2017.
Vesper, Inga (12 October 2017). "European drug regulation at risk of stalling as agency prepares to leave London". Nature News. Archived from the original on 17 May 2022. Retrieved 13 October 2017.
Bocci, Michele (20 November 2017). "Ema, Milano passa al secondo turno di votazioni con Amsterdam e Copenhagen" [Ema, Milan passes second in terms of votes with Amsterdam and Copenhangen]. la Repubblica (in Italian). Archived from the original on 9 November 2020. Retrieved 20 October 2017.
Stubbs, Jack (9 December 2020). "Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say". Reuters. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
"Cyberattack on EMA – update 5". European Medicines Agency. 15 January 2021. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
"Statement on EMA Cyberattack". Pfizer. 9 December 2020. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Tinari, Serena (10 March 2021). "The EMA covid-19 data leak, and what it tells us about mRNA instability". BMJ. 372: n627. doi:10.1136/bmj.n627. ISSN 1756-1833. PMID 33692030. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Lovett, Samuel (11 March 2021). "European regulator raised concern over quality of early Pfizer vaccine batches, leaked emails show". The Independent. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Committee for Medicinal Products for Human Use (CHMP) (19 February 2021). "European public assessment report (EPAR) – Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified)" (PDF). European Medicines Agency. Archived (PDF) from the original on 12 September 2023. Retrieved 16 September 2023.
Kansteiner, Fraser (15 March 2021). "Pfizer's COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report". Fierce Pharma. Archived from the original on 10 July 2023. Retrieved 16 September 2023.
Sherwood, Ted (16 April 2008). "Generic Drugs: Overview of ANDA Review Process" (PDF). Food and Drug Administration. Archived from the original (PDF) on 19 January 2017. Retrieved 30 January 2010.

who.int

cdn.who.int

"Annex 5: Countries and Organizations that Contributed to the Elaboration of the GVAP" (PDF). World Health Organization. Decade of Vaccines Collaboration. Archived (PDF) from the original on 17 September 2023. Retrieved 17 September 2023.

worldcat.org

search.worldcat.org

Tinari, Serena (10 March 2021). "The EMA covid-19 data leak, and what it tells us about mRNA instability". BMJ. 372: n627. doi:10.1136/bmj.n627. ISSN 1756-1833. PMID 33692030. Archived from the original on 16 September 2023. Retrieved 16 September 2023.
Abbasi, Jennifer (13 April 2021). "Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups". JAMA. 325 (14): 1385. doi:10.1001/jama.2021.5002. ISSN 0098-7484. PMID 33847730.