The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders. These include entities involved in the development ...

In order to harmonize the European procedure under the HTA Regulation with the procedure in Germany, the Federal Ministry of Health submitted a draft for the first amendment of the Medicinal ...

Proposal for a regulation amending regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and ...

Key takeaway #3As regards orphan medicinal products, the EU Pharma Package introduces a global orphan marketing authorization ...

The system and its functionalities were mandated by European law under the Falsified Medicines Directive (FMD) and are managed by consortia of stakeholders. The European Medicines Verification ...

In the European Union (EU), OMPD is granted by the EC following a recommendation from the European Medicines Agency (EMA) via its Committee for Orphan Medicinal Products (COMP).

--BioArctic AB's partner Eisai today announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has reaffirmed its positive opinion for the anti-Aβ ...

Biobusiness Briefs Published: 30 November 2018 Regulatory watch European regulatory experience with advanced therapy medicinal products Lisbeth Barkholt, Caroline Voltz-Girolt, June Raine, Tomas ...

A panel of the European medicines regulator has recommended approving an eco-friendly version of AstraZeneca's inhaler for ...

Prime Minister Robert Abela's recent appeal at the European Union summit in Brussels brings to the forefront a pressing issue faced by peripheral countries like Malta in the European Union single ...

Veterinary medicines: new EU rules to enhance availability and fight against antimicrobial resistance (press release, 13/06/2018) Proposal veterinary medicinal products compromise text The regulation ...

The Committee for Medicinal Products for Human Use (CHMP) reaffirms positive opinion for Lecanemab in early Alzheimer's disease in the EU Provided by PR Newswire Feb 28, 2025 5:11am ...