RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
  • Feature ArticlesFeature Articles

    Implementation of IVDR and MDR Into National Legislation

    This article discusses current revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in the European Union (EU). The authors use an example from Germany’s experience and efforts to examine revisions from an implementation perspective. The impact of this new regulatory environment and associated challenges for medical device and in vitro diagnostic device manufacturers are discussed as well as hurdles and “bottlenecks” that could m...