The International Council for Harmonisation (ICH) met in Charlotte, NC, USA on 10-15 November 2018.

The MedDRA Management Committee noted that 1 March 2019 will mark the 20 year anniversary of the first release of MedDRA.

The use of the Formatted Letter Template will become obsolete as of 1st January 2019. This will concern all EMA Human and Veterinary submission (including PSUSA procedures) and companies should no longer use the Formatted Template as a part of the Cover Letter in Module 1 of eCTD sequences or Part 1 of VNeeS dossier. [...]

Seretide Evohaler and related names (fluticasone propionate/salmeterol xinafoate End of procedure: 09/07/2018 Date of publication: 25/10/2018

The ICH Q3C(R7) Guideline, which is the result of an error correction of the Permitted Daily Exposure (PDE) for ethyleneglycol in the ICH Q3C(R6) Guideline, and the Q3C Support Documents 1, 2 and 3, which contain the summaries of the toxicity data from which the PDEs were derived for the original ICH Q3C Guideline, are [...]

The ICH S11 draft Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Medicines

Typhim Vi (Salmonella Typhimurium) End of procedure:13/07/2018 Date of publication: 02/10/2018

Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council came into force on 27 January 2017. With VNeeS version 2.6 now in force, [...]

The ICH M9 draft Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and has entered the public consultation period.

The ICH E9(R1) Step 2 Training Material was produced by the ICH E9(R1) Expert Working Group to accompany the Draft ICH E9(R1)