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ICH Adds Four New Regulatory Observers

Posted 14 June 2019 | By Zachary Brennan 

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.
  • E2D(R1) Post Approval Safety Data Management: Definition and Standards for Expedited Reporting, which is proposing to incorporate “pragmatic potentially risk-based approaches of the management of information from existing and any new data sources, to enable a greater focus on the data sources that will optimize signal detection activities and public health.”
  • A new Guideline on Non-clinical Biodistribution Studies for Gene Therapy Products, which will “recommend types of the nonclinical studies with which collection of biodistribution data is considered informative and/or necessary to support dosing in early clinical trials, and which will provide guidance on the design of the studies. This will result in streamlined development of the gene therapy products with higher scientific rigor while minimising the unnecessary use of animals.”
The Assembly also endorsed a forthcoming strategic reflection paper on real world data entitled, “Strategic Approach to International Harmonization of Technical Scientific Requirements for Pharmacoepidemiological Studies Submitted to Regulatory Agencies to Advance More Effective Utilization of Real-World Data.” A discussion group on the paper will be established, too.

ICH also said it plans to publish on its website the results of a survey conducted this year on monitoring the adequacy of implementation and adherence to ICH guidelines. In addition, ICH is holding a public stakeholder meeting in Tokyo on 25 July 2019.

ICH Meeting

MedDRA Management Committee


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