As a follow up to measures taken by the SC in June 2013 towards increased transparency in the ICH Process, the ICH Procedure document is now published on the ICH website.

A comprehensive report of the last ICH meeting that was held in La Hulpe (Brussels), Belgium on 1-6 June 2013 is now available on the ICH website under the SC Reports page.

The ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in July 2013 and now enters the consultation period (Step 3).

Template of letter of intent for the submission of a worksharing procedure (June 2019) Link to EMA website for Template cover letter for worksharing including CAPs and MRPs

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)