EU Medicines Agency @EMA_News@respublicae.eu

EMA and HMA updated their guidance for identifying and disclosing confidential information and personal data in marketing authorisation application of medicines➡️https://europa.eu/!tMrtgD
This ensures transparency when disclosing information to the public on authorised medicines.
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https://nitter.privacydev.net/EMA_News/status/1869327383804932431#m

Our Executive Director, Emer Cooke, takes stock of EMA's 2024 achievements.
This is the first year EMA issued more than 100 positive opinions for a marketing authorisation since 2009.
Read the full end-of-year message: https://www.ema.europa.eu/en/news/emer-cooke-emas-executive-director-2024-achievements-medicine-regulation #EU #PublicHealth
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https://nitter.privacydev.net/EMA_News/status/1869017356120592714#m

RT by @EMA_News: 📣Attention clinical trials sponsors!
New year will come with important changes: 30 Jan 2025 marks the end of the transition period to the new Clinical Trials Regulation (CTR).
Ensure your compliance:
🔗 https://europa.eu/!PX9fPm
#HealthUnion
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https://nitter.privacydev.net/EU_Health/status/1868927878844629401#m

📢 EMA recommends 17 new medicines 💊 for approval:
☑️ 1st medicine to treat #vonHippel-Lindau disease
☑️ 1st treatment for for #PeripheralThyrotoxicosis in patients with Allan-Herndon-Dudley syndrome
☑️ 2 medicines to treat #cancer
👉https://europa.eu/!gg9d6y
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https://nitter.privacydev.net/EMA_News/status/1867538407322272136#m

🎧 Great listen 🎧with EU experts (including our Chief Medical Officer Steffen Thirstrup) on why we need an all-hands-on-deck approach to fight
https://nitter.cz/search?q=%23AMR
<p>
https://nitter.cz/EFSA_EU/status/1757725791301910652#m
</p>

🐦🔗: https://nitter.cz/EMA_News/status/1757742515669635436#m

[2024-02-14 12:24 UTC]

RT by @EMA_News: ICYMI: #ConversationsOnCancer for #WorldCancerDay with @EMA_News and patients &amp; investigators. Learn about therapies transforming care for patients with CML, multiple myeloma &amp; melanoma.
Watch: https://www.youtube.com/watch?v=7IWz_xhm194

#GlobalCancerMoonshot

🐦🔗: https://nitter.cz/FDAOncology/status/1757417619626381638#m

[2024-02-13 14:53 UTC]

RT by @EMA_News: Would you like to be a part of the Critical Medicines Alliance? Learn more and express your interest to join through the open call until 16 February!

🐦🔗: https://nitter.cz/EC_HERA/status/1757441163240353909#m

[2024-02-13 16:26 UTC]

The consultation on the concept paper on human
https://nitter.cz/search?q=%23phage
therapies will be open until 31 March.
Have your say in the first EMA guideline on these medicines, that could help us fight
https://nitter.cz/search?q=%23antibioticresistance
and open up new routes to treating infections. 👇
https://www.ema.europa.eu/en/development-and-manufacture-human-medicinal-products-specifically-designed-phage-therapy-scientific-guideline#ema-inpage-item-64733

🐦🔗: https://nitter.cz/EMA_News/status/1756936175082704897#m

[2024-02-12 07:00 UTC]

At its February meeting, EMA's
https://nitter.cz/search?q=%23safety
committee reminded healthcare professionals of the risk of serious adverse reactions with the COVID-19 therapeutic Paxlovid, when taken together with certain immunosuppressants.
👉
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-5-8-february-2024
https://nitter.cz/search?q=%23SafetyOfMedicines
https://nitter.cz/search?q=%23PRAC

🐦🔗: https://nitter.cz/EMA_News/status/1755929090509426959#m

[2024-02-09 12:18 UTC]

Interested in joining our pilot for academic 🎓 and not-for-profit developers of advanced therapy medicines?
EMA has already accepted 3⃣ developers who are receiving enhanced support. 2⃣ additional places are available.
Find out more to apply ⬇️
https://www.ema.europa.eu/en/news/progress-update-pilot-academic-non-profit-developers-advanced-therapy-medicines

🐦🔗: https://nitter.cz/EMA_News/status/1755616411576393924#m

[2024-02-08 15:35 UTC]

Don't forget to register for the EMA/
https://nitter.cz/EORTC
workshop exploring how patient reports on their own health and quality of life can inform regulatory decisions on
https://nitter.cz/search?q=%23cancertreatments
🔗
https://europa.eu/!TVfryM
💻16 Feb - registration deadline

🐦🔗: https://nitter.cz/EMA_News/status/1754873653546701080#m

[2024-02-06 14:24 UTC]

RT by @EMA_News: Happening Now! Conversations on Cancer for #WorldCancerDay with @EMA_News and patients &amp; investigators. Learn about therapies transforming care for patients with CML, multiple myeloma &amp; melanoma.
https://www.youtube.com/watch?v=7IWz_xhm194

#GlobalCancerMoonshot

🐦🔗: https://nitter.cz/FDAOncology/status/1753063584240738378#m

[2024-02-01 14:31 UTC]

RT by @EMA_News: Thank you to the ACT-EU team at the @EMA_News for the amazing workshop last week. Bringing the community together to explore use cases for #ClinicalTrial data analytics using CTIS &amp; EUDRACT illustrates how forward-thinking, collaborative &amp; #PatientCentric EMA truly is.

🐦🔗: https://nitter.cz/EatrisEric/status/1752674114425200846#m

[2024-01-31 12:44 UTC]

RT by @EMA_News: Save the date for a #ConversationsonCancer with @EMA_News for #WorldCancerDay. A panel of patients, investigators &amp; regulators will dive into the latest therapies transforming care for patients with chronic myeloid leukemia, multiple myeloma, and melanoma. https://www.surveymonkey.com/r/HDNCD2Y

🐦🔗: https://nitter.cz/FDAOncology/status/1751996409094504871#m

[2024-01-29 15:51 UTC]

RT by @EMA_News: Meet Feb 1 #ConversationsOnCancer panelists: Biru Yelak @IMFmyeloma; Jan Geissler @WECANadvocate; Stergios Moschos @UNC; Carolin Pothet @EMA_News; Ellin Berman @mskcancercenter; Frederik Ostman; Edward Laane; &amp; FDA's Vab Kumar, Rea Blakey &amp; Rick Pazdur
https://www.surveymonkey.com/r/HDNCD2Y

🐦🔗: https://nitter.cz/FDAOncology/status/1752001441168793654#m

[2024-01-29 16:11 UTC]

RT by @EMA_News: MPE shared patient perspectives at the ACT EU Clinical Trials Analytics Workshop last week. Thanks to @EMA_News for the opportunity to contribute to improving access and usability of clinical trial data.

@LungCancerEu
@AlfonsoAguaron
#ACTEU #myeloma #ClinicalTrials

🐦🔗: https://nitter.cz/MyelomaEurope/status/1751951541185994904#m

[2024-01-29 12:52 UTC]

The new platform supporting the collection of data by EU/EEA Member States on the sales and use of antimicrobials in animals is now live! 🚀
This is a major European milestone in the fight against
https://nitter.cz/search?q=%23AntibioticResistance
. 🦠👊
https://www.ema.europa.eu/en/news/new-platform-collection-sales-and-use-data-antimicrobials-animals
https://nitter.cz/search?q=%23OneHealth
https://nitter.cz/search?q=%23HealthUnion

🐦🔗: https://nitter.cz/EMA_News/status/1751981890314092754#m

[2024-01-29 14:53 UTC]

We are excited to embark on a new project, as part of
https://nitter.cz/search?q=%23TeamEurope
https://nitter.cz/EU_Partnerships
to support regulatory systems in Africa and the setup of the African Medicines Agency (AMA), together with African, European and global partners
👉
https://www.ema.europa.eu/en/news/ema-support-establishment-african-medicines-agency

🐦🔗: https://nitter.cz/EMA_News/status/1751862745954476400#m

[2024-01-29 07:00 UTC]

📢 EMA's human medicines committee, the
https://nitter.cz/search?q=%23CHMP
, recommended 3⃣ new medicines for approval:
☑️ a medicine to treat urinary infections,
https://nitter.cz/search?q=%23Pneumonia
&amp; bacteria in the bloodstream
☑️ a medicine to treat
https://nitter.cz/search?q=%23Neutropenia
☑️ a medicine to treat
https://nitter.cz/search?q=%23Schizophrenia
https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-january-2024

🐦🔗: https://nitter.cz/EMA_News/status/1750857301517332635#m

[2024-01-26 12:24 UTC]

EMA recommended 1⃣4⃣
https://nitter.cz/search?q=%23veterinary
https://nitter.cz/search?q=%23medicines
for marketing authorisation in 2023. 🐾 💊 💉
More than half of these had a new active substance which had never been authorised in the 🇪🇺 before.
Check out our annual veterinary medicines highlights ⬇️

🐦🔗: https://nitter.cz/EMA_News/status/1750440567199162717#m

[2024-01-25 08:48 UTC]