Other content tagged: Europe
A pressing need for research to reduce nutritional uncertainties in preterm infant care: Findings from a European roundtable discussion with parent representatives
Clinical uncertainties regarding best practices on preterm nutrition will be addressed in a future randomised control trial. However, researchers first sought the views and experiences of parents of preterm babies and adults born preterm to consider them during the study design. The results of two roundtable discussions showed strong support for further research but also revealed variation in participants' knowledge about research trials and in information provided to parents during a baby's hospital stay. Researchers…
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The legislative framework of donor human milk and human milk banking in Europe
When mothers own milk is not available, donor human milk (DHM) is the best alternative to nourish preterm or sick babies. Nevertheless, human milk banks (HMB) within Europe are rarely and heterogeneously regulated. A study reviews these differences in regulations and their implications for the use of DHM. Results confirm the importance of establishing a national and international regulatory framework for HMB.…
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Expert Roundtable on Human Milk Regulation in the EU
On 3 June, a group of interdisciplinary and international high-level experts in the field of human milk joined our digital roundtable on “Human Milk Regulation”. The aim of the meeting was to explore and discuss the need for a harmonised regulatory approach of human milk in the European Union. Silke Mader (Chairwoman EFCNI) and Professor Enrico Bertino (President EMBA) welcomed the group and thanked for the engagement to join the project, followed by an introduction to the work of EFCNI.…
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Expert feedback wanted: new EMA guideline drafted for public consultation
The European Medicines Agency (EMA) released a draft guideline for public consultation on the quality requirements for medical devices in human medicines that include a medical device, known as drug-device combinations. The guideline covers devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but obtained separately. It is intended that this guideline will increase transparency and consistency of information in regulatory…
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European Commission launches new version of the Union Register on May 3, 2019
The European Commission launched a new version of its Union Register of medicinal products, listing all medicinal products authorised by the Commission, in total over 1,300 medicines. The Union Register was first established in 1995 and, besides medicinal products for human and veterinary use, includes also orphan drugs. The register also informs about refused authorisations or withdrawn requests, and medicines that are authorised only on a national level. In this new version, there are…
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