Guideline revisions support the EU’s ongoing transition away from using animals for in vivo testing of parenteral medicines.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has removed references to the rabbit pyrogen test (RPT) in twenty newly published guidelines revisions, set to be enforced on 1 July.
This move aligns with the European Pharmacopoeia (Ph. Eur.) Commission’s broader strategy to phase out the RPT across regulatory testing frameworks.
The revised documents are 19 revised EU Official Control Authority Batch Release (OCABR) guidelines and Article 58 EU Official Control Authority Batch Compliance Testing of GSK’s Mosquirix, the first vaccine approved for malaria globally.
Adopted by the EU OCABR Network, the guidelines reinforce a harmonised and transparent approach to batch release, supporting the safety and efficacy of immunological medicinal products in the EU.
Consistent with Ph. Eur. general chapter 5.1.13 (Pyrogenicity), the revised guidelines adopt the term ‘pyrogenicity’ to describe testing for both endotoxin and non-endotoxin pyrogens.
From 1 July, OMCLs and manufacturers will be required to apply appropriate pyrogen test(s) in accordance with the principles established in that general chapter, rather than defaulting to the RPT as a standard approach.
The update reflects the pharmaceutical sector’s ongoing commitment to the 3Rs principles relating to animal use in scientific procedures: Replacement, Reduction and Refinement.
Removal of the RPT from OCABR testing requirements, illustrates EDQM’s progress in accelerating the transition towards alternative, non-animal pyrogen testing methodologies.
Last month, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published a new guideline relevant to mRNA vaccines produced with LNPs and two revised guidelines for vaccines to treat infectious diseases, following its adoption on 1 May. The recommendations offer a harmonised framework for the co-ordinated, independent control of COVID-19 (mRNA) vaccines, COVID-19 and seasonal influenza combined (mRNA) vaccines and respiratory syncytial virus (mRNA) vaccines.
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