The European Commission (EC) has released the outcome of the proposed changes to its variations rules in early February. The proposed changes as described “were not considered sufficiently clear and clarification has been requested” by the 40 stakeholders, the EC summarized.
The commission notes that the contributions received were “extensive and detailed,” adding that the summary document focuses only on “comments related to new variations or new wording in the classification of variations that were common to a significant number of contributors.”
Commenting were 14 individual companies and the same number of industry associations, as well as the national authorities from Germany, Spain, Denmark, France and Norway. The full comments are available on the EC website (link provided below).
The “public consultation paper” on the EC review of its 2008 variations regulation (1234/2008) was issued by the Commission in September, 2011 (IPQ “The News in Depth” October 19, 2011).
At a CASSS Europe CMC Strategy Forum the following April in Berlin, Germany, EMA Biological Section Head Peter Richardson discussed the consultation results in the context of other EU quality-related initiatives (IPQ “The News in Depth” June 1, 2012).
He explained that as a result of the stakeholder input, discussions were taking place at the EMA regarding:
● changes to stability protocols
● frequent questions to competent authorities on how to classify novel
● inconsistencies between the active ingredient and the product, and areas where that consistency was missing in the quality-by-design fields, including design spac
● what is critical and non-critical, and
● submission of variations for updating viral safety data in the file.