Twelve new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended twelve medicines for approval at its July 2026 meeting.The committee…, CHMP statistics Key figures from the July 2026 CHMP meeting are…
CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Bexatil for the reduction of hyperglycaemia in cats…
EMA and the European Innovation Council and SMEs Executive Agency (EISMEA) have strengthened their cooperation in support of health innovation in the European Union (EU). Today…, Enabling innovation is central to our public health mission…
Brussels, 14 July 2026Check against deliveryDear Ms Jerkovic, dear honourable members, thank you for the invitation today and for this opportunity to report on EMA’s…
PRAC agrees new safety information on desogestrel- and etonogestrel-containing contraceptives and Litfulo, a medicine to treat alopecia areata Desogestrel- and etonogestrel-…, Agenda Agenda of the PRAC meeting 6-9 July 2026Draft Reference…
EMA’s human medicines committee (CHMP) has started a phased review of data on daraxonrasib, a medicine intended for the treatment of metastatic pancreatic cancer. A phased…
EMA is launching initiatives to better embed women’s health considerations in medicines development and regulation. Women live longer than men on average but spend more of their…, Advancing developments in women’s health is one of my…
Six new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended six medicines for approval at its June 2026 meeting.The committee recommended…, CHMP statistics Key figures from the June 2026 CHMP meeting are…
CVMP opinions on veterinary medicinal productsThe Committee adopted a negative opinion for a marketing authorisation for Scovella (velagliflozin), a product classified as…
Crisis preparedness and responseThe Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and…
PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent Committee recommends updating product…, Agenda Agenda of the PRAC meeting 8-11 June 2026Draft…
Today, EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important…
EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO…
June is PRIDE month and EMA starts a two-month celebration of diversity and inclusion in science and healthcare, leading up to its participation in the world-famous Amsterdam…, Our strength in the EU comes from our unity in diversity.…
EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant XFG for the 2026/2027 vaccination campaign.XFG is part of the…
This news announcement was updated on two occasions. On 7 May 2026, it was updated to include additional recommendations for strains for seasonal egg-derived and live-attenuated…
CVMP opinions on veterinary medicinal productsThe Committee adopted a positive opinion for a marketing authorisation for Nobivac NXT HC, for the active immunisation of …
Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2026 meeting.Jascayd (nerandomilast)…, CHMP statistics Key figures from the May 2026 CHMP meeting are…
EMA has recommended granting a marketing authorisation in the European Union (EU) for Jascayd (nerandomilast) to treat adults with idiopathic pulmonary fibrosis (IPF) or…
EMA’s office is closed on 25 May, to mark Whit Monday. The office reopens 08:30 on Tuesday, 26 May.The product emergency hotline is available outside working hours and on…
The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published their first report tracking progress against the EU’s new clinical trial targets.…
EMA is actively monitoring the ongoing hantavirus outbreak linked to a cruise ship, in coordination with other EU bodies.The virus has been identified as Andes hantavirus, the…
EMA's office is closed from 18:00 on 13 May 2026 until 08:30 on 18 May 2026.The product emergency hotline is available outside working hours and on public holidays. To reach…
EMA welcomes the provisional agreement reached by the European Parliament and the Council of the European Union on the proposed Critical Medicines Act (CMA), which represents an…, “At a time of increasing global disruptions, resilient and…
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 4-7 May 2026Draft Reference…
EMA has set up a new advisory group on vaccine confidence, which will advise the Agency on issues related to vaccine hesitancy and help guide its actions to increase science…, "Vaccine hesitancy is a growing global threat to public health.…
EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory…
Update as of 18 May 2026'CHMP statistics' graphic - updated figures for total negative opinions on new medicines and for positive opinions on extensions of therapeutic…, CHMP statistics Key figures from the April 2026 CHMP meeting are…
EMA has recommended granting a marketing authorisation in the European Union (EU) for Redemplo (plozasiran) to treat adults with familial chylomicronaemia syndrome (FCS).FCS is…
EMA's office is closed for King's Day in the Netherlands on 27 April and for Labour Day on 1 May 2026.Outside of working hours and on public holidays, it is…