News and press releases
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US, , 16/08/2019
Fri, 16 Aug 2019 14:30 +0200
EMA and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of...
EMA closed 15 August 2019 , , 13/08/2019
Tue, 13 Aug 2019 17:45 +0200
EMA is closed from 18:30 on Wednesday 14 August until 7:30 on Friday 16 August 2019.Outside of working hours and on public holidays, it is possible to...
Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published , , 31/07/2019
Wed, 31 Jul 2019 14:00 +0200
EMA and the US Food and Drug Administration (FDA) have published today a  report  on their joint workshop with stakeholders held on 26 November...
Names of liposomal medicines to be changed to avoid medication errors, , 31/07/2019
Wed, 31 Jul 2019 12:15 +0200
All marketing authorisation holders of medicines containing liposomal drug delivery systems are requested to submit to EU regulators a variation to...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019, CHMP, 26/07/2019
Fri, 26 Jul 2019 12:10 +0200
Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its July 2019 meeting.The...
First ‘histology-independent’ treatment for solid tumours with a specific gene mutation, CHMP, 26/07/2019
Fri, 26 Jul 2019 12:00 +0200
EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Vitrakvi (larotrectinib) for the...
Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy, , 26/07/2019
Fri, 26 Jul 2019 12:00 +0200
EMA has recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who...
Paediatric Committee elects Koenraad Norga as its new chair, PDCO, 24/07/2019
Wed, 24 Jul 2019 16:52 +0200
At its July 2019 meeting, EMA’s paediatric committee (PDCO) elected Koenraad Norga from Belgium as its new chair, for a three-year mandate starting in...
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 16-18 July 2019, CVMP, 19/07/2019
Fri, 19 Jul 2019 15:31 +0200
CVMP concludes referral procedure and recommends suspension of veterinary medicines containing paromomycin to be administered parenterally to pigsCVMP...
EMA takes note of the European Ombudsman’s decision on pre-submission activities, , 19/07/2019
Fri, 19 Jul 2019 10:12 +0200
EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing...

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