Great Demand for Regulatory Life Cycle Management in Biomedicine

A national and European regulatory drug authority such as the PEI is an important location factor for pharmaceutical and biotechnology companies wishing to place medicines on the market is. The safety of patients has to be kept in mind as well as the smooth supply and constant development of new vaccines and biomedical drugs with a favourable benefit-risk profile. The PEI, the Federal Institute for Vaccines and Biomedicines, is developing its know-how with a view to the future through its own research and is taking over procedures for complex biomedical drugs. On the occasion of the meeting with representatives of the vfa as well as pharmaceutical and biotech companies, it presented important administrative and content innovations.

The meeting with the vfa has a long tradition and took place for the tenth time this year. A dialogue with drug manufacturers is an important prerequisite for providing regulatory support for innovative biomedical drugs on their way to the marketing authorisation. "From our point of view, a regular exchange in which all questions relating to the development and regulation of drugs can be addressed is an important contribution to medical progress," said Professor Klaus Cichutek, President of the PEI, emphasising the importance of the meeting.

Other topics included an overview of planned and ongoing centralised procedures in PEI. As in previous years, biomedicine is booming - the number of applications for clinical trials of predominantly very complex biomedical drugs continues to rise. The PEI's continuing leading position in the field of biomedicine in the committees of the European Union, the extensive range of scientific advice from drug development to application and thereafter were further topics of discussion. A new simultaneous national scientific advisory procedure proposed by the PEI is in the pilot phase.