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Highlights of the safety committee: October 2023MEDICINES |COMMITTEES
Highlights of the safety committee: October 2023
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Highlights of the safety committee: October 2023MEDICINES |COMMITTEES
Highlights of the safety committee: October 2023
At its monthly meeting, EMA's safety committee, the PRAC, discussed new safety information for medicines containing omega-3-acid ethyl esters
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New ACT EU video releasedClinical Trials |Regulatory
New ACT EU video released
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New ACT EU video releasedClinical Trials |Regulatory
New ACT EU video released
Watch a video to learn about how the Accelerating Clinical Trials in the EU (ACT EU) initiative is transforming the way clinical trials are initiated, designed, and run
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CHMP highlights: September 2023MEDICINES |COMMITTEES
CHMP highlights: September 2023
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CHMP highlights: September 2023MEDICINES |COMMITTEES
CHMP highlights: September 2023
EMA's human medicines committee (CHMP) recommended nine new medicines for approval in the EU at its September 2023 meeting.
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EMA cooperation with HTA bodies in the EUHTA Regulation |EUnetHTA
EMA cooperation with HTA bodies in the EU
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EMA cooperation with HTA bodies in the EUHTA Regulation |EUnetHTA
EMA cooperation with HTA bodies in the EU
The EMA-EUnetHTA cooperation is coming to an end, but preparations are continuing for the implementation of the regulation on health technology assessment.
Latest news
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List item29/09/2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 September 2023
New safety information for Omega-3-acid ethyl esters The PRAC agreed to add atrial fibrillation (irregular, rapid contraction of the heart) as a common side effect to the product information for medicines containing omega-3-acid ethyl esters. These...
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List item15/09/2023
Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies
Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology...
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List item15/09/2023
EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
On 21 September, the company that markets Blenrep asked for re-examination of the CHMP opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its recommendation and issue a final recommendation. Once the re-examination has...
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List item15/09/2023 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023
Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting. The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for the...
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List item15/09/2023
EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a...
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List item14/09/2023 COVID-19
Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax vaccine targeting the Omicron XBB.1.5 subvariant. The vaccine — known as Spikevax XBB.1.5 — is to be used for preventing COVID-19 in adults and children from 6...
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