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Management Board: Highlights of October 2023 meeting
Management Board |HighlightsManagement Board: Highlights of October 2023 meeting
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Management Board: Highlights of October 2023 meeting
Management Board |HighlightsManagement Board: Highlights of October 2023 meeting
The Board adopted revised transparency rules for the Clinical Trials Information System and was updated on EMA’s activities in the first half of 2023
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Revision of transparency rules for clinical trials
Clinical Trials |RegulatoryRevision of transparency rules for clinical trials
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Revision of transparency rules for clinical trials
Clinical Trials |RegulatoryRevision of transparency rules for clinical trials
EMA revised rules to give faster access to information in the EU Clinical Trials Information System
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Highlights of the safety committee: October 2023
MEDICINES |COMMITTEESHighlights of the safety committee: October 2023
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Highlights of the safety committee: October 2023
MEDICINES |COMMITTEESHighlights 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 released
Clinical Trials |RegulatoryNew ACT EU video released
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New ACT EU video released
Clinical Trials |RegulatoryNew 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
Latest news
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List item06/10/2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 October 2023
The Committee adopted by consensus a positive opinion for a marketing authorisation Nobivac LoVo L4 (a duplicate of Nobivac L4), from Intervet International B.V., a vaccine for the active immunisation of of dogs against Leptospira interrogans...
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List item06/10/2023
EMA Management Board: highlights of October 2023 meeting
EMA’s Management Board met on 5 October in Amsterdam. Clinical trials in the EU The Board adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The...
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List item06/10/2023
Revised transparency rules for the EU Clinical Trials Information System (CTIS)
EMA has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System . The simplifications introduced will give access to clinical trial information to stakeholders...
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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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