Cooperations

Shareholders

1.) Cooperation with the competent authorities of the shareholders:

InphA cooperates intensively with the competent authorities of its shareholding member states. The core business is the receipt of samples taken due to surveillance of pharmaceutical companies, and the transmission of the results obtained from testing the samples. Additionally, at the request of the authorities, InphA’s scientific staff participates as analytical experts during inspections of pharmaceutical companies.

Regular meetings take place with the heads of the inspectorates of the shareholding member states which, among other things, serve to promote coordination between the states and InphA with regard to an efficient and appropriate testing.

Germany

2.) Cooperation at a national level:

  • InphA is represented in the expert group 8 (EFG 8), in which the heads of the German OMCLs meet regularly for discussions of topics of common interest under the direction of the Central Authority of the Länder for Health Protection with regards to Medicinal Products and Medical Devices (ZLG)
  • For projects, there are also contacts to the German licensing authority, the Federal Institute for Drugs and Medical Devices (BfArM). InphA is in collaboration with BfArM for example involved in the elaboration of monographs for the European Pharmacopoeia

Europe

3.) Cooperation on European level:

InphA is an active participant in the network of European OMCLs, coordinated by the European Directorate for the Quality of Medicines & Healthcare (EDQM) in Strasbourg. This includes, among other things:

  • participation in quality assuring interlaboratory tests (PTS = proficiency testing studies)
  • testing of preparations that have been centrally authorized by the European Medicines Agency (EMA) in London
  • performing of European market survey studies, and
  • inspections by the OMCL network for the assurance of uniform quality standards in the European OMCLs

International

4.) International cooperation

There is cooperation on individual projects with the World Health Organisation (WHO) in the following areas:

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