ICH collaborates with Standards Development Organisations to enforce globalisation of its standards

GMP News No. 838

GMP News
16 November 2006

ICH collaborates with StandardsDevelopment Organisations to enforce globalisation of its standards

As announced in a press release end of October, theInternational Conference on Harmonisation (ICH) will "collaborate withaccredited Standards Development Organisations (SDOs) to leverage thedevelopment of technical standards for ICH e-Initiatives."

By collaborating the organisation expects that more non-ICH countries willimplement its standards, making them global standards. This would resultin more efficient processes and worldwide more uniform drug developmentrequirements.

With the goal of harmonising submissions globally, the ICH also reportsthat chemical and biotech quality experts met to identify areas inpharmaceutical quality which need to be addressed across all products atthe ICH level. Further discussions are planned for the next ICH meeting,scheduled for May 2007.

The ICH quality standard is also the centre of the ECA"ICHQ9 Training Course" and "ICHQ10 and FDA Quality System Training Course"from 20-22 June 2007 in Berlin, Germany.
Wolfgang Heimes
On behalf of ECA


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