EMA Takes Flexible Approach In Setting Exposure Limits for Drugs Produced In Shared Facilities

07 May 2018

• By Joanne S. Eglovitch

The European Medicines Agency on April 30 issued an updated question and answer guidance that accords manufacturers more flexibility in meeting health-based exposure limits for drugs produced in shared facilities.

bended scientist works with manufacture machine

The European Medicines Agency on April 30 issued an updated question and answer guidance that allows manufacturers more flexibility in meeting health-based exposure limits for drugs produced in shared facilities.

In this revision, EMA acceded to industry and regulator demands that two controversial provisions be scrapped – a “highly hazardous”...