Pharmaceutical Regulatory Affairs: Open Access

Enzmann H

Publications

• Case Report
  Development of Innovative Medicines for European Patients and Impact of Brexit
  Author(s): Enzmann H and Norta MEnzmann H and Norta M
  
  European patients may benefit from innovative medicines only at the end of a complex process with a sequence of positive decisions on different levels by different stakeholders. The decision of the industry to invest in a usually global clinical development must be followed by a European marketing authorization decision and a mostly national decision on price and reimbursement until finally patients and their physicians can make an individual treatment decision. Development strategies must consider the evolution of scientific and procedural requirements. Current trends are characterized by an enhanced cooperation of regulators and health technology assessment-bodies. The increasing availability of innovative personalized or precision medicines is reflected in the new procedural tools like European Medicines Agency’s priority medicines scheme and adaptive pathways concept. The UK.. Read More»
  DOI: 10.4172/2167-7689.1000171

  Abstract PDF