-
Highlights of the Safety Committee: January 2023
MEDICINES |COMMITTEESHighlights of the Safety Committee: January 2023
-
Highlights of the Safety Committee: January 2023
MEDICINES |COMMITTEESHighlights of the Safety Committee: January 2023
PRAC recommends aligning the dosing of Janus kinase (JAK) inhibitors in patients with certain risk factors
-
Implementation of the Clinical Trials Regulation
Clinical trials |RegulatoryImplementation of the Clinical Trials Regulation
-
Implementation of the Clinical Trials Regulation
Clinical trials |RegulatoryImplementation of the Clinical Trials Regulation
On 31 January 2023, the Clinical Trials Information System (CTIS) will become mandatory for all authorisation applications for a clinical trial in the EU
-
End-of-year message from EMA’s Executive Director
Statement |Executive DirectorEnd-of-year message from EMA’s Executive Director
-
End-of-year message from EMA’s Executive Director
Statement |Executive DirectorEnd-of-year message from EMA’s Executive Director
In this statement, Executive Director Emer Cooke looks back at 2022 and gives insights into the year ahead
-
Facilitating EU Decentralised Clinical Trials
Clinical Trials |RegulatoryFacilitating EU Decentralised Clinical Trials
-
Facilitating EU Decentralised Clinical Trials
Clinical Trials |RegulatoryFacilitating EU Decentralised Clinical Trials
As part of ACT EU, EMA, the European Commission and the Heads of Medicines Agencies published recommendations to facilitate the conduct of decentralised clinical trials in the EU
Latest news
-
List item13/01/2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 - 12 January 2023
Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious side effects associated with Janus kinase (JAK)...
-
List item21/12/2022
End-of-year message from EMA’s Executive Director
We are rapidly approaching the end of 2022 and the festive season, which for many of us is one of the most wonderful times of the year – mainly because we reunite with family and friends from near and far to celebrate, to embrace. This has become...
-
List item20/12/2022 COVID-19
EMA business hours over holiday period
The European Medicines Agency's (EMA) office is closed from 18:30 on Thursday 22 December 2022 to 07:30 on Wednesday 4 January 2023. Essential work related to the COVID -19 pandemic and crisis response will continue during this period. Outside of...
-
List item19/12/2022
Facilitating Decentralised Clinical Trials in the EU
The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and...
-
List item16/12/2022
EMA Management Board: highlights of December 2022 meeting
At its meeting of 14-15 December 2022 in Amsterdam, the European Medicines Agency (EMA) Management Board heard an update on the recent activities related to the response to COVID-19. Since the start of the pandemic, a total of seven vaccines, four...
-
List item16/12/2022 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2022
Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2022 meeting. The CHMP recommended granting a conditional marketing authorisation for the advanced therapy...
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