Celebrating a Refreshed and Revitalised New Visual Identity for MedDRA

Furthering the discussions on structural changes and increased engagement of regulators globally that took place in San Diego in November 2012, the ICH SC agreed measures aimed at increased transparency – a step forward in fostering openness as ICH continues its pursuit of greater harmonisation.

The MedDRA Management Board met in La Hulpe, Belgium on 1 - 2 June 2013.

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).