Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory assessment time for purely national variation and renewal applications in the Nordic Countries - a retrospective data analysis

Dr. Tom Deutschle (Abschlußjahr: 2011)

Language: English

Introduction: The vast majority of authorisations granted in the European Union are purely national marketing authorisations. Since the year1995 a European variation system was evolved in order to harmonise the handling of variation applications and to reduce the regulatory burden both for industry and authorities. The present study examines the regulatory assessment time for purely national variation and renewal applications in the Nordic Countries submitted under the Regulations 541/95/EC, 1084/2003/EC and 1234/2008/EC.

Method of analysis: The regulatory data base of a medium-sized generic company was used as basis for analysis which was performed by calculating the differences (delta days) between the submission and approval/refusal date of purely national variation and renewal applications.

Results: The key observations were the increased median time for national TypeIA variation applications assessed under Regulation 1234/2008/EC in comparison to Regulation 1084/2003/EC in Denmark, Finland and Sweden. However, the assessment of national TypeIB variation applications was accelerated under Regulation 1234/2008/EC in the Nordic Countries except of Finland. Few data is available for national TypeII variation applications assessed under Regulation 1234/2008/EC in the Nordic Countries, but in Denmark the median assessment time decreased. The median assessment time for purely national renewal applications in the Nordic Countries was calculated to 262days which exceeds the official timeline of 90days by a factor of 3.

Conclusion: The regulatory assessment times for purely national TypeIA variation and renewal applications in the Nordic Countries do not yet fully comply with the assessment times fixed in the national legislation. The Norwegian system of handling TypeIA variation applications under Regulation 1234/2008/EC makes regulatory work easier both for the agency and the applicant since the Norwegian agency considered TypeIA variation applications accepted after 30days unless the agency does have any objections. Currently, Regulation 1234/2008/EC is under review to enlarge its scope on the handling of variation applications for purely national marketing authorisations. The benefit of this review remains to be seen.

Pages: 48