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Other content tagged: Europe

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 The register also informs about refused authorisations or withdrawn requests, and medicines that are authorised only on a national level.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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