-
Achievements of the Regulatory Science StrategyRegulatory Science |Report
Achievements of the Regulatory Science Strategy
-
Achievements of the Regulatory Science StrategyRegulatory Science |Report
Achievements of the Regulatory Science Strategy
EMA published a report summarising the mid-term achievements of the Regulatory Science Strategy to 2025
-
Management Board: Highlights of March 2023 meetingManagement Board |Highlights
Management Board: Highlights of March 2023 meeting
-
Management Board: Highlights of March 2023 meetingManagement Board |Highlights
Management Board: Highlights of March 2023 meeting
The Board received updates on the Agency’s extended mandate and the recent operational experience with the clinical trials information system
-
Human medicines: highlights of 2022Medicines |Highlights
Human medicines: highlights of 2022
-
Human medicines: highlights of 2022Medicines |Highlights
Human medicines: highlights of 2022
EMA recommended 89 human medicines for marketing authorisation in 2022. Check out our overview of key recommendations on the authorisation and safety monitoring of human medicines
-
Veterinary medicines: highlights of 2022Medicines |Highlights
Veterinary medicines: highlights of 2022
-
Veterinary medicines: highlights of 2022Medicines |Highlights
Veterinary medicines: highlights of 2022
EMA recommended 10 veterinary medicines for marketing authorisation in 2022. Check out our overview of key recommendations on the authorisation and safety monitoring of veterinary medicines
-
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...
-
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...
-
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...
-
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...
-
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...
-
List item26/01/2023
EMA update on shortages of antibiotics in the EU
EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing...
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