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

The ICH S10 Guideline on Photosafety Evaluation reached Step 4 of the ICH Process in November 2013 and now enters the implementation period (Step 5).

Latanoprost/Timolol End of procedure: 09/09/2013 Date of publication: 02/12/2013

The ICH SC furthered discussions on governance and increased engagement of regulators globally that had taken place in La Hulpe (Brussels) in June 2013.

ICH is pleased to announce the publication of a new brochure entitled “Understanding MedDRA”.

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