-
Supporting development of medicines for children
Supporting development of medicines for children
-
Supporting development of medicines for children
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
-
Multi-stakeholder platform to improve clinical trials
Multi-stakeholder platform to improve clinical trials
-
Multi-stakeholder platform to improve clinical trials
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
-
New role for EMA during public health emergencies
New role for EMA during public health emergencies
-
New role for EMA during public health emergencies
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
-
CTIS now mandatory for new trial applications
CTIS now mandatory for new trial applications
-
CTIS now mandatory for new trial applications
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)
Information for you
Key content
Services & databases
-
List item
Clinical Trials website
-
List item
Account Management portal
-
List item
eSubmission
-
List item
EudraVigilance (human)
-
List item
EudraVigilance Veterinary
-
List item
Veterinary Medicines information website
-
List item
Suspected adverse drug reactions database
-
List item
Clinical data
-
List item
SPOR data management services
-
List item
Service Desk
-
List item
IRIS platform
-
List item
Public register of parallel distribution notices
-
List item
European Vaccination Information Portal