Miconazole nitrate End of procedure: 14/12/2012 Date of publication: 06/03/2013

The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH Process in February 2013 and now enters the consultation period (Step 3).

The ICH E2C(R2) Guideline on Periodic Benefit-Risk Evaluation Report reached Step 4 of the ICH Process in November 2012 and now enters the implementation period (Step 5).

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 International Conference on Harmonisation (ICH) Steering Committee (SC) and its Expert Working Groups (EWGs) met in San Diego, California, USA on November 10-15, 2012.

The MedDRA Management Board met in San Diego, CA, USA on 10-11 November 2012.

In October 2012, the Draft eCTD Implementation Guide (v0.1) was released under Step 2 for Testing to give an opportunity to stakeholders to conduct testing to confirm its technical feasibility.

The final meeting report of the last Global Cooperation Group (GCG) meeting that was held in Fukuoka, Japan on June 5, 2012 is now available on the ICH website under the GCG Reports page.

The ICH M1 "Points to Consider" Working Group updated the “MedDRA Term Selection” and the “Data Retrieval and Presentation” documents to provide best practice approaches for data entry (coding) and data retrieval/analysis for MedDRA version release 15.1.