AGES Experts as Rapporteurs for EMA Reflection Paper
AGES MEA experts took the rapporteur role for the development of the new EMA document: "Reflection Paper on statistical methodology for the comparative assessment of quality attributes in drug development" (EMA/CHMP/138502/2017).
Over the past 2.5 years, experts from AGES Medical Market Surveillance have been involved in the development of a new document as part of their committee work for the Biostatistics Working Party of the EMA (European Medicines Agency), which summarizes important questions on the topic of 'Comparative data analysis in the field of drug quality' from a regulatory-scientific perspective.
This 'Reflection Paper' was published on the EMA homepage in March 2017, and is currently available for public comment. It is expected that the representations in the Reflection Paper and subsequent further discussions and actions will have significant impact on the development programs of some important groups of medicines - such as biosimilars. On the one hand, the main responsibility for the development of this document illustrates the high level of competence that AGES Medizinmarktaufsicht (MEA) has been able to establish in the international arena in the expert field of biostatistics in recent years. On the other hand, this project should serve as an example that both resources and expertise of national authorities are essential for the development of international and multidisciplinary regulatory guidelines.
In May 2018, a one-and-a-half-day workshop will be held at EMA to review comments from the public comment period. The program design for this event, as well as any resulting follow-up (revision of the Reflection Paper, initiation of follow-up documents) will be the responsibility of the MEA Rapporteur. Thus, the MEA's commitment to this area of international cooperation with the involvement of the pharmaceutical industry will remain clearly visible in the future.
