Meeting between PEI and the German Federal Association of the Pharmaceutical Industry focussed on development and marketing authorisation of biomedicines

In Europe, innovative biomedicines are usually authorised under the centralised authorisation procedure for all member states of the European Economic Area (EEA). These procedures are co-ordinated by the European Medicines Agency (EMA), the risk/benefit assessment being performed by experts of national medicines agencies. Professor Klaus Cichutek, president of the PEI, presented an overview of the centralised authorisation procedures for medicines in the PEI's remit from 2015 to 2018. "I am delighted that our experts were appointed rapporteur or co-rapporteur for 37 centralised procedures, i.e. most of the procedures in the field of biomedicines in Europe," said Professor Cichutek.

The PEI offers a helpful service for the development of modern biomedicines by providing bespoke scientific advice. Medicines developers are thus given the opportunity to take into account at an early stage important requirements in the marketing authorisation procedure, speeding up processes while maintaining the quality, safety and efficacy standards of new medicines. PEI's Innovation Office has recently taken over Scientific Advice co-ordination, reducing waiting times for applicants.

Other topics of the meeting included supply shortages of influenza vaccines during the 2018/2019 flu season, and how such situations can be prevented in the future. A needs-oriented advance order system of influenza vaccines is to be established pursuant to the "Timely Service and Supply Act" (Terminservice- und Versorgungs­gesetz, TSVG) and is intended to make an important contribution to solving this problem.

Meeting PEI and BPI Source: PEI