Di­vi­sion Ma­jor Pol­i­cy Is­sues, Co­or­di­na­tion

From the coordination of internal processes at the Paul-Ehrlich-Institut (PEI) to the implementation of international projects for the regulation of medicinal products – the division is active at the interfaces between many disciplines. The division’s experts represent the PEI in relevant committees of the European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA). Furthermore, the division coordinates the PEI's cooperation with the World Health Organization (WHO), including the two WHO Collaborating Centres, and other international actors. A recent additional task is to position the PEI as a European reference laboratory (EU-RL) for in vitro diagnostic devices (IVDs) in accordance with the new European IVD Regulation and to foster the respective application of the PEI.

Medicinal Major Policy Issues Unit

The unit combines a number of overarching interdisciplinary duties. As the head of the unit is a member of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA), committee work is one of the unit’s major areas of focus. The CHMP paves the way for decisions on the marketing authorisation of innovative medicinal products for the European market by issuing its expert opinion. The PEI’s Innovation Office, which is also based in the unit, arranges regulatory consultations for academic institutions and start-up companies in Germany with the appropriate PEI experts at an early stage of product development. Another pillar of the unit’s activities is the coordination of research at the PEI, which includes key elements such as the postgraduate education programme PEP-BIOMED and dealing with external funding programmes.

EU Co-operation Biomedicinal Products Unit

The unit coordinates cooperation at the European level. This includes not only communicating with the European Medicines Agency (EMA) and other medicines agencies in Europe, but also aligning the PEI with European procedures and guidelines and providing support for the PEI’s representatives on the various European committees. The unit organises internal peer reviews to ensure the quality of the assessments of new medicinal products and adherence to the “dual control” principle by multiple participants. The unit is also responsible for representing the PEI on the European CMDh committee, which clarifies issues relating to decentralised marketing authorisation procedures between the representatives of the European member states’ medicines agencies.

International Coordination, Regulatory Service Unit

The unit supports agencies in sub-Saharan Africa in the establishment of regulatory expertise for blood products and vaccines, organized in two projects under the umbrella of the Global Health Protection Programme (GHPP). The management of the WHO Collaborating Center (WHO-CC) for the Standardization and Evaluation of Vaccines is also based within the unit. The unit also includes a group of assessors with wide-ranging expertise in various product groups. If required, they can be deployed in a variety of ways to respond flexibly to new challenges – for example, possible new procedures gained as a result of Brexit.

Updated: 21.11.2019