International – ICH Adds Four New Regulatory Observers

Regulators from Argentina, Israel, Jordan and Saudi Arabia were recently approved by the International Council for Harmonisation (ICH) Assembly as Regulatory Observers. The approvals came at a meeting from 1-6 June in Amsterdam.

ICH said the meeting was its largest biannual meeting ever and that progress was made on existing guidelines, training materials to support guideline implementation, the details of an ICH meeting in Silver Spring, MD, on 31 October on the revision of the guideline ICH E8 on clinical trials, and the council decided to work on four new topics.

The four new topics for ICH harmonization include:

  • Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin, which is proposed as an update and to expand the scope of the guideline to include new biotech products, such as viral-like particles and viral-vectored particles.
  • E6(R3) Guideline for Good Clinical Practice, which is a revision to address the increasing diversity of study types and data sources used to support regulatory and health policy decisions, in line with the ICH reflection paper on Good Clinical Practice (GCP) renovation…