30 August 2013

Further to the publication of the consensus Regulatory Notice Document and draft Appendix of Weight-of-Evidence approach for Public input by the regulatory authority in each ICH region, comments were collected from the public on the proposal.

The S1 EWG reviewed all comments received during 2013 and recently finalised the “Regulatory Notice" that specifies the agreed upon details of the prospective trial data collection period.

The final “Regulatory Notice" is now made available on the ICH website and its publication marks the beginning of the prospective data collection period.

For more details, see the revised S1 Concept Paper and Business Plan and the “Final Regulatory Notice” document on the Safety Guideline page.