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Supporting development of medicines for childrenPaediatric |Report
Supporting development of medicines for children
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Supporting development of medicines for childrenPaediatric |Report
Supporting development of medicines for children
An EMA and European Commission report highlights improvements, such a pilot on ‘stepwise’ paediatric investigation plans for certain medicines, brought by their 2018 action plan
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Multi-stakeholder platform to improve clinical trialsClinical trials |Regulatory
Multi-stakeholder platform to improve clinical trials
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Multi-stakeholder platform to improve clinical trialsClinical trials |Regulatory
Multi-stakeholder platform to improve clinical trials
EMA, the Heads of Medicines Agencies and the European Commission are launching a public consultation on a multi-stakeholder platform aimed to improve clinical trials in the EU
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New role for EMA during public health emergenciesExtended mandate |Regulatory
New role for EMA during public health emergencies
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New role for EMA during public health emergenciesExtended mandate |Regulatory
New role for EMA during public health emergencies
Additional responsibilities for monitoring and mitigation shortages of critical medical devices during public health emergencies now apply
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CTIS now mandatory for new trial applicationsClinical trials |Regulatory
CTIS now mandatory for new trial applications
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CTIS now mandatory for new trial applicationsClinical trials |Regulatory
CTIS now mandatory for new trial applications
From 31 January 2023, all initial clinical trial applications in the European Union must be submitted via the Clinical Trials Information System (CTIS)
Latest news
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List item06/02/2023
Actions to support the development of medicines for children
Regulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children. These achievements are highlighted in the...
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List item03/02/2023
Public consultation on a multi-stakeholder platform to improve clinical trials in the EU
On 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi...
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List item03/02/2023
EMA Committee on Herbal Medicinal Products re-elects Emiel van Galen as Chair
At its January 2023 meeting, EMA’s Committee on Herbal Medicinal Products (HMPC) re-elected Emiel Van Galen from the Botanicals and Novel Foods at the Medicines Evaluation Board (CBG-MEB) as its Chair for another three-year mandate. “The work of the...
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List item31/01/2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU
From 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the...
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List item27/01/2023
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2023
Four new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults, a skin disease...
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List item26/01/2023
EMA Committee for Advanced Therapies elects Ilona Reischl as its new Chair
At its January 2023 meeting, EMA’s Committee for Advanced Therapies (CAT) elected Ilona Reischl from the Austrian Medicines and Medical Devices Agency (AGES MEA) as its new Chair for a three-year mandate. Before becoming Chair, Dr Reischl served as...
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