European Medicines Agency
@ema.europa.eu
EU regulatory authority working for public and animal health.
We ensure that all medicines available on the EU market are high quality, safe and effective. Based in Amsterdam.
https://www.ema.europa.eu/
We ensure that all medicines available on the EU market are high quality, safe and effective. Based in Amsterdam.
https://www.ema.europa.eu/
📢 EMA recommends: 6 new medicines 💊 for approval, including the first #GLP1 #medicine indicated for a serious liver disease and an extension of indication to the first emergency nasal spray for allergies in children.
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
January 30, 2026 at 1:02 PM
📢 EMA recommends: 6 new medicines 💊 for approval, including the first #GLP1 #medicine indicated for a serious liver disease and an extension of indication to the first emergency nasal spray for allergies in children.
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
#PublicHealth #medsky
www.ema.europa.eu/en/news/meet...
Do you still have questions about the link between #paracetamol use during pregnancy and the risk of neurodevelopmental disorders? Read the latest guest article from Steffen Thirstrup, our Chief Medical Officer, on this topic: www.linkedin.com/company/1523...
#medsky
#publichealth
#medsky
#publichealth
January 26, 2026 at 1:15 PM
Do you still have questions about the link between #paracetamol use during pregnancy and the risk of neurodevelopmental disorders? Read the latest guest article from Steffen Thirstrup, our Chief Medical Officer, on this topic: www.linkedin.com/company/1523...
#medsky
#publichealth
#medsky
#publichealth
The good #pharmacogenomic practice guideline is being updated! A concept paper is open for public consultation until 31 March 2026.
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
January 22, 2026 at 1:54 PM
The good #pharmacogenomic practice guideline is being updated! A concept paper is open for public consultation until 31 March 2026.
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
Key proposed changes:
✔️methodology updates
✔️clearer interpretation
✔️consistent reporting
✔️expanded study design guidance.
www.ema.europa.eu/en/good-phar...
Save the date for our 1st press briefing of the year!
We will:
✅ provide 2025 key developments and explore trends in human medicines
✅ spotlight advancements in therapies for endocrine & cardiovascular diseases.
It will be live on Linkedin and YouTube.
www.linkedin.com/events/74149...
#medsky
We will:
✅ provide 2025 key developments and explore trends in human medicines
✅ spotlight advancements in therapies for endocrine & cardiovascular diseases.
It will be live on Linkedin and YouTube.
www.linkedin.com/events/74149...
#medsky
January 12, 2026 at 3:04 PM
Save the date for our 1st press briefing of the year!
We will:
✅ provide 2025 key developments and explore trends in human medicines
✅ spotlight advancements in therapies for endocrine & cardiovascular diseases.
It will be live on Linkedin and YouTube.
www.linkedin.com/events/74149...
#medsky
We will:
✅ provide 2025 key developments and explore trends in human medicines
✅ spotlight advancements in therapies for endocrine & cardiovascular diseases.
It will be live on Linkedin and YouTube.
www.linkedin.com/events/74149...
#medsky
What did EMA achieve in 2025 - and what’s next? Our Executive Director, Emer Cooke, shares the vision: a faster path from innovation to safe #medicines. In 2026 we focus on reimagining EMA, innovation & people. Read more 👇
www.ema.europa.eu/en/news/emer... #medsky #health
www.ema.europa.eu/en/news/emer... #medsky #health
December 19, 2025 at 2:55 PM
What did EMA achieve in 2025 - and what’s next? Our Executive Director, Emer Cooke, shares the vision: a faster path from innovation to safe #medicines. In 2026 we focus on reimagining EMA, innovation & people. Read more 👇
www.ema.europa.eu/en/news/emer... #medsky #health
www.ema.europa.eu/en/news/emer... #medsky #health
📢 EMA recommends: 7 new medicines 💊 for approval, including 1 medicine to treat #BladderCancer and an extension of indication of a #GLP1 medicine to treat adolescents and children with type II diabetes
#PublicHealth #medsky 👇
www.ema.europa.eu/en/news/meet...
#PublicHealth #medsky 👇
www.ema.europa.eu/en/news/meet...
December 12, 2025 at 1:55 PM
📢 EMA recommends: 7 new medicines 💊 for approval, including 1 medicine to treat #BladderCancer and an extension of indication of a #GLP1 medicine to treat adolescents and children with type II diabetes
#PublicHealth #medsky 👇
www.ema.europa.eu/en/news/meet...
#PublicHealth #medsky 👇
www.ema.europa.eu/en/news/meet...
📣 New data on antimicrobials sales and their use in animals in the EU
We just published the second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet).
Check out the report and the new interactive dashboard 👇 www.ema.europa.eu/en/news/new-...
We just published the second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet).
Check out the report and the new interactive dashboard 👇 www.ema.europa.eu/en/news/new-...
December 9, 2025 at 12:48 PM
📣 New data on antimicrobials sales and their use in animals in the EU
We just published the second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet).
Check out the report and the new interactive dashboard 👇 www.ema.europa.eu/en/news/new-...
We just published the second European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet).
Check out the report and the new interactive dashboard 👇 www.ema.europa.eu/en/news/new-...
Live on 15 Dec, 9:00 CET, multistakeholder workshop on Alzheimer’s patient registries.
For registry holders, patients, regulators, pharma, clinicians, researchers, HTAs & payers to shape stronger evidence on medicine safety & effectiveness.
Watch the livestream 👇 www.ema.europa.eu/en/events/jo...
For registry holders, patients, regulators, pharma, clinicians, researchers, HTAs & payers to shape stronger evidence on medicine safety & effectiveness.
Watch the livestream 👇 www.ema.europa.eu/en/events/jo...
December 8, 2025 at 3:14 PM
Live on 15 Dec, 9:00 CET, multistakeholder workshop on Alzheimer’s patient registries.
For registry holders, patients, regulators, pharma, clinicians, researchers, HTAs & payers to shape stronger evidence on medicine safety & effectiveness.
Watch the livestream 👇 www.ema.europa.eu/en/events/jo...
For registry holders, patients, regulators, pharma, clinicians, researchers, HTAs & payers to shape stronger evidence on medicine safety & effectiveness.
Watch the livestream 👇 www.ema.europa.eu/en/events/jo...
Our safety committee, the #PRAC, has just concluded its November meeting.
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
November 28, 2025 at 11:13 AM
Our safety committee, the #PRAC, has just concluded its November meeting.
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
In 2022, there were 1 million fewer animal uses in medicines testing compared with 2015.
EMA’s 2023–24 3R Working Party report shows how science and animal welfare can go hand in hand.
Find out more: www.ema.europa.eu/en/human-reg...
EMA’s 2023–24 3R Working Party report shows how science and animal welfare can go hand in hand.
Find out more: www.ema.europa.eu/en/human-reg...
November 27, 2025 at 3:31 PM
In 2022, there were 1 million fewer animal uses in medicines testing compared with 2015.
EMA’s 2023–24 3R Working Party report shows how science and animal welfare can go hand in hand.
Find out more: www.ema.europa.eu/en/human-reg...
EMA’s 2023–24 3R Working Party report shows how science and animal welfare can go hand in hand.
Find out more: www.ema.europa.eu/en/human-reg...
Join us at the HMA/EMA Annual Data Forum 2025 to shape the future of data-driven medicines regulation in the EU!
📅 9 Dec 2025
📍 Amsterdam & Virtual
Shape the next chapter. Register now: www.ema.europa.eu/en/events/em...
#MedicinesRegulation #DataScience
📅 9 Dec 2025
📍 Amsterdam & Virtual
Shape the next chapter. Register now: www.ema.europa.eu/en/events/em...
#MedicinesRegulation #DataScience
November 25, 2025 at 1:01 PM
Join us at the HMA/EMA Annual Data Forum 2025 to shape the future of data-driven medicines regulation in the EU!
📅 9 Dec 2025
📍 Amsterdam & Virtual
Shape the next chapter. Register now: www.ema.europa.eu/en/events/em...
#MedicinesRegulation #DataScience
📅 9 Dec 2025
📍 Amsterdam & Virtual
Shape the next chapter. Register now: www.ema.europa.eu/en/events/em...
#MedicinesRegulation #DataScience
It’s World Antimicrobial Awareness Week!
AMR could cause over 8.2M deaths yearly by 2050. It threatens health systems, economies, food safety & global security.
Medicines regulators worldwide are united in tackling AMR. Now is the time to act—protect today, secure tomorrow.
AMR could cause over 8.2M deaths yearly by 2050. It threatens health systems, economies, food safety & global security.
Medicines regulators worldwide are united in tackling AMR. Now is the time to act—protect today, secure tomorrow.
November 21, 2025 at 10:51 AM
It’s World Antimicrobial Awareness Week!
AMR could cause over 8.2M deaths yearly by 2050. It threatens health systems, economies, food safety & global security.
Medicines regulators worldwide are united in tackling AMR. Now is the time to act—protect today, secure tomorrow.
AMR could cause over 8.2M deaths yearly by 2050. It threatens health systems, economies, food safety & global security.
Medicines regulators worldwide are united in tackling AMR. Now is the time to act—protect today, secure tomorrow.
New approach to accelerate the development of medicines and vaccines for public health threats like #AMR
Improved scientific advice will speed up approvals and strengthen Europe’s preparedness.
Learn more 👉 www.ema.europa.eu/en/news/impr...
Improved scientific advice will speed up approvals and strengthen Europe’s preparedness.
Learn more 👉 www.ema.europa.eu/en/news/impr...
November 17, 2025 at 1:24 PM
New approach to accelerate the development of medicines and vaccines for public health threats like #AMR
Improved scientific advice will speed up approvals and strengthen Europe’s preparedness.
Learn more 👉 www.ema.europa.eu/en/news/impr...
Improved scientific advice will speed up approvals and strengthen Europe’s preparedness.
Learn more 👉 www.ema.europa.eu/en/news/impr...
📢 EMA recommends 10 new medicines 💊 for approval, including a first-in-class treatment to delay onset of type1 #diabetes and 2 medicines to treat #cancer. Read more 👉 www.ema.europa.eu/en/news/meet... #PublicHealth #MedSky
November 14, 2025 at 11:48 AM
📢 EMA recommends 10 new medicines 💊 for approval, including a first-in-class treatment to delay onset of type1 #diabetes and 2 medicines to treat #cancer. Read more 👉 www.ema.europa.eu/en/news/meet... #PublicHealth #MedSky
🌍💊 It’s #MedSafetyWeek 2025!
EMA and partners worldwide are promoting medicine safety and encouraging everyone to report suspected side effects.
🔍 Find out how the EU system works to keep medicines safe.: www.ema.europa.eu/en/about-us/...
#MedSky
EMA and partners worldwide are promoting medicine safety and encouraging everyone to report suspected side effects.
🔍 Find out how the EU system works to keep medicines safe.: www.ema.europa.eu/en/about-us/...
#MedSky
November 7, 2025 at 11:23 AM
🌍💊 It’s #MedSafetyWeek 2025!
EMA and partners worldwide are promoting medicine safety and encouraging everyone to report suspected side effects.
🔍 Find out how the EU system works to keep medicines safe.: www.ema.europa.eu/en/about-us/...
#MedSky
EMA and partners worldwide are promoting medicine safety and encouraging everyone to report suspected side effects.
🔍 Find out how the EU system works to keep medicines safe.: www.ema.europa.eu/en/about-us/...
#MedSky
💊 New booklet: “From laboratory to patients - How the safety of medicines is ensured in the European Union”
Published for #MedicineSafetyWeek — explore how EMA & EU countries work together to keep medicines safe and safeguard the health of patients.
👉 www.ema.europa.eu/en/about-us/...
Published for #MedicineSafetyWeek — explore how EMA & EU countries work together to keep medicines safe and safeguard the health of patients.
👉 www.ema.europa.eu/en/about-us/...
November 6, 2025 at 11:16 AM
💊 New booklet: “From laboratory to patients - How the safety of medicines is ensured in the European Union”
Published for #MedicineSafetyWeek — explore how EMA & EU countries work together to keep medicines safe and safeguard the health of patients.
👉 www.ema.europa.eu/en/about-us/...
Published for #MedicineSafetyWeek — explore how EMA & EU countries work together to keep medicines safe and safeguard the health of patients.
👉 www.ema.europa.eu/en/about-us/...
The HMA/EMA multi-stakeholder workshop on AI is coming up on 20–21 Nov! Join us for updates on AI regulation, HMA/EMA activities, and real-world AI use cases across the medicines lifecycle. Learn more about the livestream info & agenda: www.ema.europa.eu/en/events/hm...
November 5, 2025 at 2:12 PM
The HMA/EMA multi-stakeholder workshop on AI is coming up on 20–21 Nov! Join us for updates on AI regulation, HMA/EMA activities, and real-world AI use cases across the medicines lifecycle. Learn more about the livestream info & agenda: www.ema.europa.eu/en/events/hm...
Our safety committee, the PRAC, has just agreed on a communication for healthcare professionals concerning the use of injectable tranexamic acid. Read more: www.ema.europa.eu/en/news/meet...
October 31, 2025 at 1:03 PM
Our safety committee, the PRAC, has just agreed on a communication for healthcare professionals concerning the use of injectable tranexamic acid. Read more: www.ema.europa.eu/en/news/meet...
One big highlight from today’s ACT EU annual meeting: the launch of the first EU-wide clinical trials map 🌍
Now available in all EU/EEA languages, making trials easier to find and join.
Explore the map 👉 euclinicaltrials.eu/search-for-c...
Now available in all EU/EEA languages, making trials easier to find and join.
Explore the map 👉 euclinicaltrials.eu/search-for-c...
October 29, 2025 at 4:36 PM
One big highlight from today’s ACT EU annual meeting: the launch of the first EU-wide clinical trials map 🌍
Now available in all EU/EEA languages, making trials easier to find and join.
Explore the map 👉 euclinicaltrials.eu/search-for-c...
Now available in all EU/EEA languages, making trials easier to find and join.
Explore the map 👉 euclinicaltrials.eu/search-for-c...
📢 New reflection paper on using non-human primates (NHPs) in medicine safety testing now open for consultation. A key step toward major reduction in NHP use.
Have your say until 31 January 2026: www.ema.europa.eu/en/non-human...
Have your say until 31 January 2026: www.ema.europa.eu/en/non-human...
October 23, 2025 at 1:57 PM
📢 New reflection paper on using non-human primates (NHPs) in medicine safety testing now open for consultation. A key step toward major reduction in NHP use.
Have your say until 31 January 2026: www.ema.europa.eu/en/non-human...
Have your say until 31 January 2026: www.ema.europa.eu/en/non-human...
📢 EMA recommends 2 new medicines 💊 for approval:
☑️ The first treatment for non-cystic fibrosis #bronchiectasis
☑️ 1 medicine to treat persistent or chronic immune
#thrombocytopenia
Check out the highlights 👇
www.ema.europa.eu/en/news/meet...
More on bronchiectasis 👇
www.ema.europa.eu/en/news/firs...
☑️ The first treatment for non-cystic fibrosis #bronchiectasis
☑️ 1 medicine to treat persistent or chronic immune
#thrombocytopenia
Check out the highlights 👇
www.ema.europa.eu/en/news/meet...
More on bronchiectasis 👇
www.ema.europa.eu/en/news/firs...
October 17, 2025 at 11:15 AM
📢 EMA recommends 2 new medicines 💊 for approval:
☑️ The first treatment for non-cystic fibrosis #bronchiectasis
☑️ 1 medicine to treat persistent or chronic immune
#thrombocytopenia
Check out the highlights 👇
www.ema.europa.eu/en/news/meet...
More on bronchiectasis 👇
www.ema.europa.eu/en/news/firs...
☑️ The first treatment for non-cystic fibrosis #bronchiectasis
☑️ 1 medicine to treat persistent or chronic immune
#thrombocytopenia
Check out the highlights 👇
www.ema.europa.eu/en/news/meet...
More on bronchiectasis 👇
www.ema.europa.eu/en/news/firs...
EMA's October 2025 Management Board highlights are now available. The Board noted EMA's mid-year report and endorsed the first data strategy for the European medicines regulatory network. Read more here 👉https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2025-meeting
October 3, 2025 at 1:38 PM
EMA's October 2025 Management Board highlights are now available. The Board noted EMA's mid-year report and endorsed the first data strategy for the European medicines regulatory network. Read more here 👉https://www.ema.europa.eu/en/news/ema-management-board-highlights-october-2025-meeting
Our safety committee, the #PRAC, has just concluded its October meeting.
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
October 3, 2025 at 11:50 AM
Our safety committee, the #PRAC, has just concluded its October meeting.
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
PRAC responsibilities cover all aspects of the risk management of the use of medicines.
Find out more in the PRAC highlights: www.ema.europa.eu/en/news/meet...
EDQM joins an EU initiative with EMA to strengthen medicines regulation across Sub-Saharan Africa 🌍.
This means boosting lab networks and supporting the African Medicines Agency. A big step for access to safe, quality medicines.
www.ema.europa.eu/en/partners-...
#TeamEurope #GlobalHealth
This means boosting lab networks and supporting the African Medicines Agency. A big step for access to safe, quality medicines.
www.ema.europa.eu/en/partners-...
#TeamEurope #GlobalHealth
September 26, 2025 at 9:04 AM
EDQM joins an EU initiative with EMA to strengthen medicines regulation across Sub-Saharan Africa 🌍.
This means boosting lab networks and supporting the African Medicines Agency. A big step for access to safe, quality medicines.
www.ema.europa.eu/en/partners-...
#TeamEurope #GlobalHealth
This means boosting lab networks and supporting the African Medicines Agency. A big step for access to safe, quality medicines.
www.ema.europa.eu/en/partners-...
#TeamEurope #GlobalHealth
📢 EMA recommends 14 new medicines 💊 for approval, including:
☑️ 1 medicine for respiratory syncytial virus #RSV
☑️ 1 medicine to treat vasomotor symptoms associated with #Menopause
☑️ 1 medicine to treat #Diabetestype2
www.ema.europa.eu/en/news/meet...
#PublicHealth
☑️ 1 medicine for respiratory syncytial virus #RSV
☑️ 1 medicine to treat vasomotor symptoms associated with #Menopause
☑️ 1 medicine to treat #Diabetestype2
www.ema.europa.eu/en/news/meet...
#PublicHealth
September 19, 2025 at 10:22 AM
📢 EMA recommends 14 new medicines 💊 for approval, including:
☑️ 1 medicine for respiratory syncytial virus #RSV
☑️ 1 medicine to treat vasomotor symptoms associated with #Menopause
☑️ 1 medicine to treat #Diabetestype2
www.ema.europa.eu/en/news/meet...
#PublicHealth
☑️ 1 medicine for respiratory syncytial virus #RSV
☑️ 1 medicine to treat vasomotor symptoms associated with #Menopause
☑️ 1 medicine to treat #Diabetestype2
www.ema.europa.eu/en/news/meet...
#PublicHealth