The PSUR Work Sharing and Synchronisation Project was initiated in 2002 under the auspices of the HMA and the European Risk Management Strategy Facilitation Group (ERMS FG). The concept of the project was that substances would have harmonised birthdates allowing MAHs to submit PSURs for products containing the same substance to NCAs at the same [...]
When Directive 2010/84/EC introduced the principle of EU PSURs single assessment (PSUSA procedure) for substances authorised in more than one member state, a step-wise approach was taken to the full implementation of new PSUR procedures; the EMA Management Board decided that the implementation of the new procedure for substances only included in NAPs should have [...]
Referral to CMDh (RMS) (March 2013) D90/210 referral request (CMS) (July 2011)
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.