The SC is pleased to announce the decision that Heath Canada (HC) and Swissmedic are now Steering Committee members.

The Steering Committee will meet in Minneapolis, MN, USA from May 31 to June 5 to discuss ongoing harmonisation activities.

In March 2014, the ICH E2C(R2) Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports [...]

In March 2014, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Concentration-Response Relationships, Combination Products, Large Targeted Proteins and Monoclonal Antibodies and Special Cases.

A comprehensive report of the last ICH meeting that was held in Osaka, Japan on 9-14 November 2013 is now available on the ICH website under the SC Reports page.

PAR Scientific discussion (February 2014)

On 28 March 2014, DIA and EFPIA (one of the funding member of ICH) are organising an “Information Day on ICH” to provide an update on the status of active topics and potential new topics to be harmonised.

Geneva, February 10, 2014 – The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is considering a Call for Tender in 2014 for the contract for the MedDRA Maintenance and Support Services Organization (MSSO).

Metoprolol succinate End of procedure: 13/07/2013 Date of publication: 26/09/2013 Update: 04/02/2014

Member: Teodor Nikolov Alternate: Ivelina Terzieva Bulgarian Drug Agency 8 Damyan Gruev Str. BG-1303 SOFIA