New ICH Guideline Could Hold The Key To Better Global Management Of Product Variations

The growing complexity of procedures for making post-approval changes to product dossiers at global level is proving problematic for regulators and companies alike. Andrew Deavin, director of global regulatory affairs at GSK Vaccines, spoke to the Pink Sheet’s Ian Schofield about ongoing efforts to achieve greater regulatory convergence in life cycle management processes, including a new ICH guideline that could prove a “paradigm shift” in the handling of variations.

Efforts are underway to tackle the complexities of post-approval changes at global level