Responsibilities for IgG Fc fusion proteins
2024.08.28
Information for Pharmaceutical Companies
Specifications regarding responsibilities for IgG Fc fusion proteins
In order to simplify the situation for pharmaceutical companies (PU) and developers, the Paul-Ehrlich-Institut, the Federal Institute for Vaccines and Biomedicines (PEI), and the Federal Institute for Drugs and Medical Devices (BfArM) have agreed to transfer primary responsibilities regarding IgG Fc fusion proteins to the BfArM.
The practical implementation of the provisions of the Medicinal Products Act (Arzneimittelgesetz, AMG) regarding the responsibilities of the Paul-Ehrlich-Institut or the Federal Institute for Drugs and Medical Devices (BfArM) for IgG Fc fusion proteins (usually identifiable by the suffix "-cept" in the International Nonproprietary Name [INN] system) has led in the past to overlapping activities between the institutes.
The transfer of responsibility applies to all regulatory procedures, both before authorisation (e.g. consultation, approval of the clinical trial) and after authorisation.
With the fundamental transfer of these products to the BfArM's remit, applications for batch release or applications for exemption from the batch testing obligation are no longer necessary.
Exceptions required in individual cases
Exceptions to this rule are necessary in individual cases. One example is that of recombinant coagulation factors with Fc component and complex Fc fusion proteins, which also contain the Fab (antigen-binding) component of an antibody.
All recombinant constructs containing a Fab component and all antibody conjugates, such as antibodies covalently linked to chemotherapeutic agents, toxins, radionuclides or oligonucleotides, remain the responsibility of the Paul-Ehrlich-Institut.
What's next?
Any currently ongoing procedures (e.g. for clinical trials) will be completed by the respective institutes.
New submissions after 28 August, 2024, will follow the new conditions.