4 December 2012

In November 2012, the SC endorsed the revision of both the S1 Concept Paper and Business Plan to provide clarification concerning how the prospective data gathering period should be integrated in the normal ICH Step process. The revised S1 Concept Paper and Business Plan now describe the S1 strategy which consists of first preparing a draft "Regulatory Notice for Public Input" to be issued by each ICH regulatory health authority to solicit comments from the public to the proposal, the procedure, and the specific weight-of-evidence criteria. A final “Regulatory Notice" is planned to be published in June 2014 and will mark the beginning of the prospective data collection period. After collecting and incorporating results from the prospective analyses, a Step 2 document is planned to be published in November 2016, and a Step 4 document finalised in November 2017.

The ”Regulatory Notice for Public Input” document バンズ スニーカー ナイキ レブロンwas finalised in November 2012 and will be published by regulators in the three ICH regions for 90-days public comment.

The document is also made available on the ICH website for public awareness.

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