> ## Content Index > Fetch the complete content index at: https://www.whiteroseintelligence.com/llms.txt > Use this file to discover other available public pages before exploring further. # European Medicines Agency - URL: https://www.whiteroseintelligence.com/european-medicines-agency/ - Published: 1999-01-02T15:49:00.000Z - Updated: 2025-10-14T18:59:55.000Z - Author: Liam Sturgess - Tags: Profiles, #docs, #organization The **European Medicines Agency (EMA)** is a multination agency of the European Union in charge of the evaluation and supervision of medicinal products. ## History The EMA contributed to the Global Vaccine Action Plan developed by the [Decade of Vaccines Collaboration](https://www.whiteroseintelligence.com/Decade-of-Vaccines-Collaboration), endorsed by the 194 Member States of the World Health Assembly in May 2012, and published on the [World Health Organization](https://www.whiteroseintelligence.com/World-Health-Organization)'s website in February 2013.[\[1\]](#fn1) ### COVID-19 The EMA is a collaborator in the [Accelerating COVID-19 Therapeutic Interventions and Vaccines](https://www.whiteroseintelligence.com/Accelerating-COVID-19-Therapeutic-Interventions-and-Vaccines) (ACTIV) initiative.[\[2\]](#fn2) While in the process of evaluating the [Pfizer–BioNTech COVID-19 vaccine](https://www.whiteroseintelligence.com/Pfizer-BioNTech-COVID-19-vaccine) (BNT162b2) in December 2020, the EMA suffered a cyberattack, resulting in the leak of classified regulatory documents to journalists, academics and the public via the dark web.[\[3\]](#fn3)[\[4\]](#fn4)[\[5\]](#fn5) The documents revealed internal concerns about low production quality in the mRNA vaccine candidate, and regulators' efforts to have [Pfizer](https://www.whiteroseintelligence.com/Pfizer) and [BioNTech](https://www.whiteroseintelligence.com/BioNTech) rectify these deficiencies.[\[6\]](#fn6)[\[7\]](#fn7)[\[8\]](#fn8) The EMA ultimately authorized the vaccine on December 21, 2020, satisfied that the product quality was "sufficiently consistent and acceptable."[\[9\]](#fn9)[\[10\]](#fn10) Covid Truths published a number of these files in April 2021, including copies of the Rapporteur's Assessment Reports.[\[11\]](#fn11) On October 29, 2022, the [Canadian Covid Care Alliance](https://www.whiteroseintelligence.com/Canadian-Covid-Care-Alliance) (CCCA) published a paper authored by [Maria Gutschi](https://www.whiteroseintelligence.com/Maria-Gutschi) based on the leaked EMA documents analyzing the manufacturing and quality issues underlying BNT162b2.[\[12\]](#fn12) A video presentation of the investigation was also published to BitChute and the CCCA website.[\[13\]](#fn13)[\[14\]](#fn14) ## Organization The EMA is a member of the Joint Coordination Group of the [Coalition for Epidemic Preparedness Innovations](https://www.whiteroseintelligence.com/Coalition-for-Epidemic-Preparedness-Innovations) (CEPI),[\[15\]](#fn15) a benefactor-level member of Health Level Seven International (HL7),[\[16\]](#fn16) as well as a member of the International Council for Harmonisation (ICH)[\[17\]](#fn17) and the International Pharmaceutical Regulators Programme.[\[18\]](#fn18) It is also a partner of the Society for Immunotherapy of Cancer[\[19\]](#fn19) and the Vaccine Confidence Project.[\[20\]](#fn20) ### Personnel | Name | Position | Notes | | -------------- | ---------------------------------------------------------------------- | ------------------------------------- | | Marco Cavaleri | Head of Biological Health Threats and Vaccines Strategy[\[21\]](#fn21) | Chair of the EMA's COVID-19 Taskforce | ## Publications - March 27, 2025: "[Guideline on the quality aspects of mRNA vaccines (Draft)](https://web.archive.org/web/20251014185148/https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-aspects-mrna-vaccines%5Fen.pdf)" ## External links - [Campfire Wiki](https://www.campfire.wiki/doku.php?id=european%5Fmedicines%5Fagency) - [Twitter](https://twitter.com/EMA%5FNews) - [Wikipedia](https://en.wikipedia.org/wiki/European%5FMedicines%5FAgency) - [Wikispooks](https://wikispooks.com/wiki/European%5FMedicines%5FAgency) --- 1. *Annex 5: Countries and Organizations that Contributed to the Elaboration of the GVAP.* World Health Organization. Retrieved June 3, 2023, from [↩︎](#fnref1) 2. *ACTIV.* National Institutes of Health (NIH). Retrieved April 1, 2022, from [↩︎](#fnref2) 3. Stubbs, J. (2020, December 9). *Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say.* Reuters. [↩︎](#fnref3) 4. Glanville, D. (2021, January 15). *Cyberattack on EMA - update 5.* European Medicines Agency. [↩︎](#fnref4) 5. *Statement on EMA Cyberattack.* (2020, December 9). Pfizer. [↩︎](#fnref5) 6. Tinari, S. (2021). *The EMA covid-19 data leak, and what it tells us about mRNA instability.* BMJ, n627\. [↩︎](#fnref6) 7. Abbasi, J. (2021). *Data Leak Exposes Early COVID-19 Vaccine Manufacturing Hiccups.* JAMA, 325(14), 1385\. [↩︎](#fnref7) 8. Lovett, S. (2021, March 11). *European regulator raised concern over quality of early Pfizer vaccine batches, leaked emails show.* The Independent. [↩︎](#fnref8) 9. Committee for Medicinal Products for Human Use (CHMP). (2021, February 19). *European public assessment report (EPAR) - Comirnaty, INN-COVID-19 mRNA Vaccine (nucleoside-modified).* European Medicines Agency. [↩︎](#fnref9) 10. Kansteiner, F. (2021, March 15). *Pfizer’s COVID-19 vaccine faced EMA manufacturing concerns ahead of emergency nod: report.* Fierce Pharma. [↩︎](#fnref10) 11. *EMA Leaked Papers.* (2021, April 17). Covid Truths. [↩︎](#fnref11) 12. Gutschi, L. M., Speicher, D. J., Natsheh, S., Oldfield, P., Britz-Mckibbon, P., Palmer, M., Karrow, N., Massie, B., Mallard, B., Chan, G., & Pelech, S. (2022). *An Independent Analysis of the Manufacturing and Quality Issues of the BNT162b BioNTech/Pfizer Quasi-vaccine based on the European Medicines Agency’s Public Assessment Report (EPAR).* Canadian Covid Care Alliance. [↩︎](#fnref12) 13. DRWR2021\. (2022, November 2). *Quality issues with mRNA Covid vaccine production.* BitChute. . Archived version available at [↩︎](#fnref13) 14. *An Independent Analysis of the Manufacturing and Quality Issues of the BNT162b BioNTech/Pfizer Vaccine (Video).* Canadian Covid Care Alliance. Retrieved November 9, 2022, from [↩︎](#fnref14) 15. *Who we are.* CEPI. Retrieved October 19, 2022, from [↩︎](#fnref15) 16. *Benefactors of Health Level Seven.* HL7 International. Retrieved June 1, 2023, from [↩︎](#fnref16) 17. *Members & Observers.* International Council for Harmonisation. Accessed April 24, 2022, from [↩︎](#fnref17) 18. *Members & Observers.* International Pharmaceutical Regulators Programme. Retrieved April 23, 2022, from [↩︎](#fnref18) 19. *Cancer Immunotherapy Partnerships and Collaborations.* Society for Immunotherapy of Cancer. Retrieved March 27, 2023, from [↩︎](#fnref19) 20. *Partnerships.* The Vaccine Confidence Project. Retrieved April 28, 2022, from [↩︎](#fnref20) 21. Kouassi, V. *Marco Cavaleri.* REVIVE. Retrieved March 8, 2023, from [↩︎](#fnref21)