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PEI

The Paul-Ehrlich-Institute (PEI) of the Federal Republic of Germany

Background

  • To establish a cooperative relationship between the two organizations, contribute to international standardization of biologics and reinforce the regulatory review, approval and research competence of both organizations

Introduction

  • The PEI located in Langen, Germany was established in 1896 as a regulatory and research organization under the Federal Ministry of Health. It is responsible for regulatory review and post-approval control of biologics, testing and research of biologics (including national lot release) and international cooperation with WHO and others.

Cooperation areas

  • Sharing of information on regulatory review of biologics
  • Training of regulatory reviewers to reinforce their competence
  • Joint research

Key activities

  • Teleconferences to discuss detailed action plans and share information on regulatory review of biologics (January and April 2014)
  • Holding of international workshop on regulatory review of biosimilars (August 28-29, 2014)
  • Invitation of PEI expert to training of regulatory reviewers in charge of review of advanced therapies (September 2-3, 2014)
  • Training of regulatory reviewers to reinforce their competence (2014, 2015)
  • Joint research (Ongoing)
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