Changes in electronic submissions of regulatory documents to the Paul-Ehrlich-Institut
Important changes apply to submissions of regulatory documents. The so-called requirement of "written form" which means that paper copies of submissions must be supplied bearing the signature of the applicant in ink no longer applies to many documents. A new introduction is PEI-C Rebuild, a portal for electronic submissions of applications for batch releases. These changes and a few additional ones are summarised in this section.
Xenotransplantation – no replication of porcine endogenous retroviruses in human cell culture
Transplantations of animal cells, tissues, or organs to humans (xenotransplantion) could in future solve the problem of short organ supply. It must, however, be guaranteed that no pathogenic agents from animals are transmitted to the human body. Researchers at the Paul-Ehrlich-Institut have now been able to prove that although porcine endogenous retroviruses (PERV) can penetrate human blood cells under certain circumstances, they cannot replicate at these sites.
Active for safe medicinal products for children - Dr Dirk Mentzer becomes chair of the EU Paediatric Committee
Dr Dirk Mentzer, paediatrician and head of the Unit Pharmacovigilance I at the Paul-Ehrlich-Institut, was elected chair of the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) this year (2013). A central role has been assigned to this committee when the so-called Paediatric Regulation came into force in 2007 to change the fact that many medicinal products are not authorised for children, even though they are required and used in children.