New Advice Format from February 2020 - Bi-national Scientific Advice
For the first time, the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, will offer bi-national scientific advice meetings together with 10 other European drug authorities from February 2020. In the future, drug developers will be able to receive scientific advice on clinical trials or change notifications involving two different national authorities in just one appointment. The binational advisory service aims to facilitate and expand pharmaceutical developers' access to regulatory advice. Upon request, the Paul-Ehrlich-Institut takes over the central coordination of appointments as well as the content-related coordination for the in-house consultations and connects the other authorities by telephone conference. Conversely, the Paul-Ehrlich-Institut takes part in attendance appointments by phone with other European pharmaceutical authorities.
The binational advisory format starts as a pilot project. Participating countries are Austria (AGES), Belgium (FAHMP), Czech Republic (SUKL), Finland (FIMEA), Hungary (OGYEI), Italy (AIFA), Norway (NOMA), Poland (URPL), Spain (AEMPS) and Germany (PEI).