The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for late-stage pre-approval or post-approval studies when the safety of a drug is well-understood.
In a separate development, ICH announced that its draft Q5A(R2) guideline on analytical testing of biotechnological products to ensure product safety has been released for consultation.
ICH E19 describes conditions for reduced data collection
The ICH E19 guideline provides internationally harmonized guidance on when it is appropriate to reduce the collection of safety data in pre-approval and post-approval clinical trials, with agreement from regulatory authorities…
