FDA and EMA Finalize Guidances to Help in Postapproval Change Management

FDA and EMA have issued final guidances intended to help industry better understand and manage the regulatory expectations for postapproval CMC changes.

In both cases, the final versions were impacted by a plethora of comments that came in on the drafts – reflective of the level of industry concern with the global filing burdens when making CMC changes.

The two guidances and the changes incorporated based on the comments, in turn, bear witness to the effort the two agencies are making to reduce those burdens and bring the CMC review paradigm into closer alignment with the continuous improvement orientation on the GMP/quality systems side.

[Editor’s Note: An in-depth review of the problems that global manufacturers face in making postapproval changes and the current industry/regulator dialogue around what can be done to address them is provided in IPQ’s February 2014 Monthly Update.]

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