Germany Regulatory Issues
Germany Regulatory Issues
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Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.
Publisher: Datamonitor Healthcare
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Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.
Germany brought in new regulations in 2010 allowing pharmaceutical firms to take part in “compassionate use” programs, which allow treatments that have yet to be approved to be used for patients with potential fatal diseases or severe disability. Besides improving transparency, the measure was also meant to improve R&D and the clinical trials environment in Germany, although the industry remains skeptical with regards to its impact.
Table of Contents
4 EXECUTIVE SUMMARY
5 DRUG APPROVAL PROCESSES IN GERMANY
5 The Federal Institute for Drugs and Medical Products is the national drugs regulatory body in
Germany
6 The EU centralized procedure is convenient but expensive
6 Decentralized procedure introduced to address disputes in mutual recognition procedure
7 Legislation on compassionate use of unapproved drugs
7 References
9 INTELLECTUAL PROPERTY
9 Patents are valid for 20 years from date of application
9 Supplementary protection certificates give extra protection
9 Pediatric SPC extension provides additional market exclusivity period
9 Data exclusivity issues in Germany: the 8+2+1 rule
10 Germany is the largest parallel import market in Europe
10 References
List of Figures
5 Figure 1: Germany – routes to obtaining market authorization
10 Figure 2: Germany – the 8+2+1 market exclusivity rule
Figure 1: Germany – routes to obtaining market authorization
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