Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model.

Regulatory science underpins the objective evaluation of medicinal products. It is therefore imperative that regulatory science and expertise remain at the cutting edge so that innovations of ever-increasing complexity are translated safely and swiftly into effective, high-quality therapies. We undertook a comprehensive examination of the evolution of science and technology impacting on medicinal product evaluation over the next 5-10 years and this horizon-scanning activity was complemented by extensive stakeholder interviews, resulting in a number of significant recommendations.

Scanning the horizon: a systematic literature review of methodologies.

Objectives: Society is confronted with the rapid emergence of innovation in science and technology. To manage this, horizon scanning is being adopted globally to identify, assess and prioritise innovations and trends at an early stage of their development. This enables decision-makers to be better informed and to prepare for change.

Pharmacogenomic information in drug labels: European Medicines Agency perspective.

Pharmacogenomics (PGx) has a growing impact on healthcare and constitutes one of the major pillars of personalised medicine. For the purpose of improved individualised drug treatment, there is an increasing effort to develop drugs suitable for specific subpopulations and to incorporate pharmacogenomic drug labels in existing and novel medicines. Here, we review the pharmacogenomic drug labels of all 517 medicinal products centrally approved in the European Union (EU) since the establishment of the European Medicines Agency in 1995.