EMA, in close collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request scientific advice…
From today, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD),…
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its January 2025 meeting.The CHMP recommended…, Positive recommendations on new medicines , Capvaxive Common…
For the first time, the five EU health and environment agencies – EFSA (European Food Safety Authority), ECDC (European Centre for Disease Prevention and Control), ECHA (European…, This joint work carries great benefits for public health…
The European Shortages Monitoring Platform (ESMP) is now live with the full scope of functionalities. This will enable marketing authorisation holders (MAHs) and national…
EMA is celebrating 30 years of operations marking its evolving role at the centre of the European Union (EU) assessing and authorising safe, high-quality medicines for 450 million…, This is a European story to be proud of and to celebrate.…
EMA has published an overview of its key recommendations of 2024 regarding the authorisation and safety monitoring of veterinary medicines. In 2024, EMA recommended 25…
EMA has recommended the approval of the vaccines Bluevac-3 and Syvazul BTV 3 to protect sheep against bluetongue disease. Bluevac-3 is also approved for use in cattle. The disease…
CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation in exceptional circumstances for Bluevac-3 (…
Medicines containing semaglutide: PRAC investigating risk of rare eye conditionPRAC will assess risk of non-arteritic anterior ischemic optic neuropathy (NAION)EMA’s safety…, Agenda Agenda of the PRAC meeting 13-16 January…
In 2024, EMA recommended 114 medicines for marketing authorisation. Of these, 46 had a new active substance which had never been authorised in the European Union (EU) before.…
EMA has published the revised version of its policies on the handling of competing interests of scientific committee members and experts (‘Policy 0044’) and of the EMA Management…
EMA is ready to support the implementation of the new regulation on health technology assessment (HTAR) (Regulation (EU) 2021/2282) when it becomes applicable on 12 January 2025.…, "EMA welcomes the new HTA regulation and is ready to do…
EMA and HMA (Heads of Medicines Agencies) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and…
We are getting closer to the end of another year - usually this time gets very busy for everyone, as we still have goals, deadlines, and ambitious plans for what we want to…, This is good news for patients, but also a very encouraging…
EMA's office is closed from 18:00 on Thursday 19 December 2024 to 08:30 on Monday 6 January 2025.Outside of working hours and on public holidays, it is possible to call the…
The report of a pilot exploring the creation and testing of ePIs (electronic product information) in real regulatory procedures was published today. The pilot found that the EU…
Work programme for 2025The Management Board adopted EMA’s work programme for 2025, which outlines how the Agency will adapt to the rapidly evolving medicines landscape and prepare…
EMA has recommended granting a marketing authorisation in the European Union (EU) for Emcitate (tiratricol), an oral treatment for peripheral thyrotoxicosis (inappropriately high…
Seventeen new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended seventeen medicines for approval at its December 2024 meeting. This brings the…, Positive recommendations on new medicines , Andembry…
EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents…
CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation application for Icthiovac ERM from …
Doxycycline: currently available evidence not supporting link with risk of suicidalityEMA’s safety committee (PRAC) has concluded that the currently available evidence is not…, Agenda Agenda of the PRAC meeting 25-28 November…
The European Shortages Monitoring Platform (ESMP) has gone live with a core set of functionalities. Using this first version of the ESMP, marketing authorisation holders (MAHs)…,
EMA is advising marketing authorisation holders to submit type IA and type IAINvariations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the…
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its November 2024 meeting.The committee recommended…, Positive recommendations on new medicines , Augtyro…
After re-examining its initial opinion, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation to Leqembi (lecanemab) for treating mild…
EMA's Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate for a vaccine platform technology master file (vPTMF) which will support and accelerate…
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines:…, Agenda Agenda of the PRAC meeting 28-31 October…
Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number and should…