In-Vitro Pyrogen Testing - Soon Part of the European Pharmacopoeia?

GMP News No. 664

GMP News
20 January 2006

In-Vitro Pyrogen Testing – Soon Part of the European Pharmacopoeia?

On November 7, 2005 the "EUROPE GOES ALTERNATIVE" CONFERENCE ON ALTERNATIVE APPROACHES TO ANIMAL TESTING which had been organised by the European Commission took place in Brussels. During this event the 3 Rs Declaration "European Partnership to Promote Alternative Approaches to Animal Testing" was signed by e.g. the European Chemical Industry Council (CEFIC), the European Association for Bioindustries (EuropaBio) as well as the European Federation on Pharmaceutical Industries and Associations (EFPIA).

The Declaration is a framework for cooperation which establishes a voluntary European Partnership aiming at Replacing, Reducing or Refining animal use and to apply advanced methodology from biosciences and medicine to develop novel, non-animal, approaches to assessing safety.

Concerning the pharmaceutical industry an emphasis was put on the importance of international collaboration in this field. The ICCVAM-ECVAM Alliance was mentioned as a very good example. Both organisations, the US Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the European Centre for the Validation of Alternative Methods (ECVAM), cooperate on test method evaluation and validation efforts. FDA's Leonard M. Schechtman and NIH's William S. Stokes gave an outlook on joint US-EU activities.

Slide taken from "Framework for Alternative Test Methods in the US", Leonard Schechtman, FDA/ Chairman of ICCVAM, CONFERENCE ON ALTERNATIVE APPROACHES TO ANIMAL TESTING, Brussels, 7 November 2005

It has been proven that both organisations take these statements seriously by the recently published Federal Register Notice from December 16, 2005, Vol. 70, No. 241, p. 74833-84. The notice informed about current ICCVAM-ECVAM activities on In-Vitro Pyrogenicity Testing Methods. It states that in June 2005, ECVAM submitted background review documents to ICCVAM on five In-Vitro pyrogenicity testing methods as a replacement for the currently required tests (i.e. rabbit pyrogen tests and bacterial endotoxin test). For the evaluation of these methods the NICEATM (Interagency Centre for the Evaluation of Alternative Toxicological Methods), in collaboration with ICCVAM, requests public comments, the nomination of expert scientists and the submission of data from the rabbit pyrogenicity test, the bacterial endotoxin test and the submission of data from In-Vitro pyrogenicity testing until January 17, 2006.

It seems that the acceptance of In-Vitro Pyrogen Testing Methods has been pushed further in Europe. During an interview for Technology Review No.1, 2006 Thomas Hartung, Head of ECVAM, stated that In-Vitro Pyrogen Testing will be included in the European Pharmacopoeia in the near future. Against the background of the recently adopted declaration this will be one contribution of the European pharmaceutical industries and regulatory bodies to the reduction of animal testing.

Join the Alternative Pyrogen Testing Conference in Bacharach/Frankfurt from 23-24 March 2006.

The German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institut and the European Compliance Academy, have invited the leading experts representing all interest groups to this jointly organised conference. The speakers will discuss the impact of the latest progressions in In-vitro Pyrogen Testing (IVPT) on pharmaceutical and biopharmaceutical quality control and assurance. You will learn about the latest Pharmacopoeial developments in the replacement of rabbit pyrogen tests and bacterial endotoxin test.

This unique event will bring together the pharmaceutical industry (e.g. Novartis, Merck, Baxter) and European authorities (e.g. NIBSC, PEI, ECVAM, EDQM).

Dr Ulrich Herber
On behalf of the European Compliance Academy


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