title: [Licensing of Pharmaceuticals and Medical Devices in Germany: Weaknesses and Opportunities].
abstract: The purpose of this study is to describe and compare the licensing of pharmaceuticals and medical devices in Germany. Weaknesses and opportunities of the respective processes are identified.Methods:To describe and compare the two approaches, a systematic literature review was conducted, followed by an archival analysis, guided by experts. Unstructured interviews were conducted with experts (users, financers, surveillants and producers) personally or by telephone to identify weaknesses and opportunities. The data were evaluated by content analysis according to Mayring and MAXQDA 11. The results were critically assessed by comparing them with the current academic literature.Results:A central market authorization for medical devices was mentioned often, but seems politically not viable. However, quality, methodology and depth of the analyses necessary for the licensing of medical devices, especially for high-risk devices, can and should strive for higher standards, comparable to those of pharmaceuticals. With regard to post-market surveillance, the systems for both pharmaceuticals and medical devices should be improved. Innovativeness and competitiveness of European medical device manufacturers should not be promoted by reduced evidence standards and patient safety. Subsidies or easier licensing procedures for small product lines with particular importance for public health, similar to orphan drug regulations, are more desirable.Conclusion:This study helps to identify areas of improvement for licensing of pharmaceuticals and medical devices. Concrete recommendations were developed. Higher evidence standards should be mandatory especially for high-risk devices, comparable to those of pharmaceuticals. Post-marketing surveillance should be improved for pharmaceuticals and medical devices.
authors.affiliation: GKV-Spitzenverband, Stabsbereich Politik, Berlin.
authors.forename: D
authors.initials: D
authors.lastname: Reinhardt
authors.affiliation: Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Oberschleißheim und Ludwig-Maximilians-Universität München.
authors.forename: M
authors.initials: M
authors.lastname: Wildner
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004864:Equipment and Supplies; D005858:Germany; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence*; D008004:Licensure / Q000331:legislation & jurisprudence*; D017146:Models, Organizational