Regulatory Highlights

In this edition we look at two specific areas. First, we consider the revision of ICH Q2(R1) and the development of ICH Q14 as they have reached the key ICH milestone of Step 2 publication for public consultation. Second, we discuss the evolving and critical area of the environmental impact of the pharmaceutical industry, highlighting in particular the impact of solvent use and the need to reduce barriers to allow recycling and reuse, which in turn will reduce the burden imposed by the need for "virgin" solvents. We examine how guidance relating to quality can impact this and discuss the need for a far more holistic approach to the use of recycling.