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ema.europa.eu

Tuesday, Jun 18

12

Faster access to clinical trial information in Europe

www.ema.europa.eu

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European…

Friday, Jun 14

17

Review of painkiller metamizole started

www.ema.europa.eu

EMA has started a review of medicines containing the painkiller metamizole following concerns that the measures in place to minimise the known risk of agranulocytosis may not be…

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2024

www.ema.europa.eu

Review of painkiller metamizole startedReview will look into risk of agranulocytosis, a sudden drop in white blood cells that can lead to serious infections, and measures to…, Agenda Agenda of the PRAC meeting 13-16 May 2024DraftReference…

16

EMA Management Board: highlights of June 2024 meeting

www.ema.europa.eu

Positive assessment of EMA’s activities in 2023The Management Board assessed and adopted the Executive Director’s annual activity report for 2023. The report describes the…

Monday, Jun 10

13

Two new advice pilots to improve clinical trials in Europe

www.ema.europa.eu

The Accelerating Clinical Trials in the EU (ACT EU) initiative is today launching two advice pilots aimed at improving the quality of applications for clinical trials, the…

Monday, Jun 3

17

EU recommendations for 2024/2025 seasonal flu vaccine composition

www.ema.europa.eu

The news announcement was updated on 3 June 2024 to include a recommendation for seasonal live attenuated influenza vaccine strains and updated information for a strain for cell-…, EMA has issued recommendations for the influenza virus…

Friday, May 31

13

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024

www.ema.europa.eu

14 new medicines recommended for approval; another seven medicines are recommended for extension of their therapeutic indicationsEMA’s human medicines committee (CHMP) recommended…, Positive recommendations on new medicines , Adzynma…

First vaccine to protect adults from Chikungunya

www.ema.europa.eu

EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya…

12

New gene therapy treatment for haemophilia B

www.ema.europa.eu

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe…

Thursday, May 30

Annual report highlights progress in science, medicines and health in 2023

www.ema.europa.eu

EMA’s annual report 2023 published today details the Agency’s contributions to public and animal health in the European Union (EU). With a fresh layout and new interactive…

Friday, May 24

13

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 May 2024

www.ema.europa.eu

CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation for Nobilis Multriva RT+IBm+ND+EDS, from…

Tuesday, May 21

15

EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

www.ema.europa.eu

Update as of 21 May 2024The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now…

Medical devices: new guidance for industry and notified bodies

www.ema.europa.eu

A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer…

10

Have your say and help shape EMA’s future communications

www.ema.europa.eu

EMA has launched its biennial communication perception survey. The purpose of the survey is to collect feedback on EMA’s external communications from patients, consumers,…

Monday, May 20

15

European medicines network designated as WHO listed authority

www.ema.europa.eu

This means that the network, composed of the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, are recognised as meeting…

Friday, May 17

17

Hydroxyprogesterone caproate medicines to be suspended from the EU market

www.ema.europa.eu

EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European…

13

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2024

www.ema.europa.eu

Hydroxyprogesterone caproate medicines to be suspended from the EU marketEMA’s safety committee (PRAC) has recommended the suspension of the marketing authorisations for medicines…, Agenda Agenda of the PRAC meeting 13-16 May…

Thursday, May 16

15

EMA closed on Whit Monday, 20 May

www.ema.europa.eu

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…

Tuesday, May 7

EMA closed 9-10 May

www.ema.europa.eu

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…

13

One Health: a joint framework for action published by five EU agencies

www.ema.europa.eu

One Health recognises the complex interplay between human, animal and plant health, food safety, the climate crisis and environmental sustainability. Implementing this approach…

Tuesday, Apr 30

12

ETF recommends updating COVID-19 vaccines to target new JN.1 variant

www.ema.europa.eu

EMA’s Emergency Task Force (ETF) has recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign.JN.1 differs from the…

Monday, Apr 29

14

EMA closed 1 May

www.ema.europa.eu

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…

Friday, Apr 26

15

Confidentiality arrangement between the EU and the Republic of Korea

www.ema.europa.eu

This new partnership between the two regulatory authorities is an important step towards mutual recognition and regulatory harmonisation to improve human and animal…

14

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024

www.ema.europa.eu

Eight new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.The CHMP recommended granting…, Positive recommendations on new medicines ,…

Tuesday, Apr 23

New recommendations to strengthen supply chains of critical medicines

www.ema.europa.eu

These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which…

Friday, Apr 19

16

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-18 April 2024

www.ema.europa.eu

CVMP opinions on veterinary medicinal products The Committee adopted by consensus a positive opinion for a marketing authorisation application for a vaccine that is effective…

Wednesday, Apr 17

10

COVID-19 vaccine strain updates: Global regulators agree on timing and data requirements

www.ema.europa.eu

International regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine strain updates that was organised by the International Coalition…

Friday, Apr 12

13

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2024

www.ema.europa.eu

The PRAC has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 receptor agonists (GLP-1) – dulaglutide, exenatide,…, Agenda Agenda of the PRAC meeting 8-11 April…

Monday, Apr 8

12

EMA systems disruption expected from 11 to 17 April

www.ema.europa.eu

During this time, EMA will load nationally and centrally authorised product data to its Product Management Service (PMS) database. This is a crucial step in making structured and…

Wednesday, Mar 27

15

Regulatory information – adjusted fees for applications to EMA from 1 April 2024

www.ema.europa.eu

The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will…