EUCOPE, in partnership with the Swedish Industry Association for Small and Medium-Sized Life Sciences Companies (IML), hosted a roundtable on the Revision of the European Orphan & Paediatric Regulation with Nordic stakeholders on 7 September. Over the last 20 years, the orphan and paediatric legislation… read more
The European legislation on paediatric medicines (EC 1901/2006) and Orphan Medicinal Products (OMPs) (EC 141/2000), which regulates the procedure for designation of OMPs and defined incentives for their research and development (R&D), is currently under review. Over the last two decades, this legislation has changed… read more
The European Commission is consulting stakeholders as part of its revision process of two major pieces of legislation, on medicines for rare diseases and paediatric patients. Central to the development of innovative treatments for these specific categories of patients, this revision process represents an important… read more
The European Commission has launched an evaluation of the Orphan Medicinal Product (OMP) and Paediatric Regulations. EUCOPE seizes the opportunity to outline ways to strengthen the EU environment for the development of rare and paediatric disease treatments, of which the Regulation (EC) No 1901/2006 on… read more
The European Commission launched an evaluation of the legislation on medicines for rare diseases and children. EUCOPE seizes the opportunity to outline ways to strengthen the whole EU environment for the development of rare diseases treatments, of which the Regulation (EC) No 141/2000 on orphan… read more
EUCOPE, in partnership with FranceBiotech, hosted a roundtable on the revision of the orphan medicine and paediatric regulations with French stakeholders on 30 June. The orphan and paediatric legislation has considerably accelerated research efforts over the last two decades and has contributed to the development… read more
As proven by the fight against COVID-19, data and digital health have the potential to drive change and improve efficiency and accessibility in healthcare. To make the most of this enormous potential, the European Commission opened a public consultation on the European Health Data Space,… read more
The complexities related to delivering some Advanced Therapy Medicinal Products (ATMPs) most likely will require highly specialized clinical expertise and infrastructures, which currently do not exist in all EU counties. Therefore, relocating or crossing borders often represent the only solution for many patients. A well-developed… read more
The multidisciplinary European Expert Group on Orphan Drug Incentives (OD Expert Group) has developed fourteen innovative proposals along the entire lifecycle of orphan drug development to address the unmet needs in rare diseases. With over ninety percent of patients without a centrally approved treatment option,… read more
The COVID-19 pandemic has again made the vital importance of the European pharmaceutical sector apparent, and while regulatory simplification is welcomed, broader business incentives should also be considered to address the EU’s competitiveness. In its response to the EU roadmap/IIA on the “Evaluation and revision of… read more
