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EMA

 •  February 13

18 medicines recommended for marketing authorisation, including ten vaccinesThe European Medicines Agency (EMA) has published an overview of its key recommendations of 2017, including for marketing authorisations of new veterinary medicines.In 2017, EMA recommended 18 medicines for marketing authorisation, an increase of more than 60% compared to...

EMA

 •  February 9

PRAC gives recommendations for valproate, flupirtine, retinoids and interim advice for EsmyaPRAC recommends new measures to avoid valproate exposure in pregnancyThe Pharmacovigilance Risk Assessment Committee (PRAC) has recommended new measures to avoid exposure of babies to valproate medicines in the womb, due to risks of malformations and...

EMA

 •  February 9

New restrictions on use; pregnancy prevention programme to be put in placeThe European Medicines Agency’s experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC) are recommending new measures to avoid exposure of babies to valproate medicines in the womb. Babies exposed are at risk of malformations and developmental...

EMA

 •  February 9

No new patients should start treatment for the time beingEuropean Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) is currently reviewing the benefits and risks with Esmya, following reports of serious liver injury, including liver failure leading to transplantation.As a temporary measure while the review is ongoing, the...

EMA

 •  February 6

Three rulings clarify the scope of commercial confidentiality with regard to authorised medicinesThe General Court delivered today three landmark rulings for the European Medicines Agency (EMA), upholding EMA’s decisions to release documents requested in accordance with Regulation (EC) No 1049/2001, the so-called “Transparency Regulation”.This is...

EMA

 •  February 1

Guideline to streamline procedures and better address the specific requirements of ATMP developers published for consultationThe European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs) for a three-month public consultation. The...

EMA

 •  February 1

Updated procedural advice clarifies regulatory process for advanced therapy medicinal products The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and...

EMA

 •  February 1

The objective of this workshops is to facilitate the long-term follow up of CAR-T cell products in a real world setting and enable the generation of meaningful efficacy and safety data using haemato-oncological registries. It will aim to agree on implementable recommendations on core data elements to collect and other matters including patient...

EMA

 •  January 31

EMA and European Commission invite stakeholders to register for joint workshop and support development of an action planThe European Medicines Agency (EMA) is inviting expressions of interest in a workshop organised together with the European Commission on 20 March 2018 to identify and discuss potential improvements to the implementation of the...

EMA

 •  January 29

EMA relocation project – press conference with Dutch authorities**Check against deliveryGood afternoon. I would like to thank the Dutch authorities for welcoming us here today and Minister Bruins for his opening remarks.As you know, the UK announced its intention to withdraw from the EU on 29 March 2019. Therefore, last November the EU27 took the...