European Union comparability testing

The major difference between application of the ICH S6 guideline in the European Union, compared to the United States and Japan, is the rather more complex interaction with the regulatory agencies in relation to agreeing on the preclinical testing strategy for biopharmaceuticals. While sponsor compa-... 

In a farsighted move in 1989, the European Union laboratory IRMM started a series of interlaboratory comparisons to provide objective evidence for the degree of equivalence and the quality of chemical measurements by comparing a participant s measurement results with external certified reference values (IRMM 2006). At the time most proficiency testing schemes used consensus results for the mean and standard deviation to derive z scores. With the IMEP-1 analysis of lithium in serum, the world was alerted to the problem of lack of accuracy in analytical measurements. The data of the first IMEP-1 trial are replotted in figure 5.6 notice that the apparent outlier was the only laboratory to come close to the assigned value. 

In recent years major developments in risk assessments of biocidal products have taken place within the European Union (EU) as a result of the implementation of the Biocidal Products Directive (BPD) 98/8/EC. This legislation will result in the highest level of testing substances and products of antimicrobial activity and will set the standard for product registration for all suppliers of biocides. Therefore, the risk assessment procedures described within the BPD technical notes for guidance will be discussed in the following sections and compared to other risk assessment procedures worldwide. 

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