Vaxigrip Tetra (quadrivalent influenza virus vaccine (inactivated, split))DE/W/0074/pdWS/003End of procedure: 10/07/2020Date of publication: 29/09/2020DE/W/0074/pdWS/004End of procedure: 04/07/2024Date of publication: 25/09/2024
The ICH Q3D(R2) draft Guideline on Elemental Impurities reached Step 2 of the ICH process on 25 September 2020.
The ICH E14/S7B draft Q&A document on “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential” reached Step 2b of the ICH Process on 27 August 2020.
The ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals reached Step 4 of the ICH Process in April 2020.
Member: Mylene FerrierAlternate: Antoine Treff Health AgencyAllée MarconiVilla LouvignyL-2120 LuxembourgLUXEMBOURG
The E2B(R3) User Guide v1.1 is available for download in the Implementation Package version 1.08 on the ESTRI webpage.
The ICH biannual meeting, scheduled to be held in Athens in November 2020 is cancelled.
D70 Preliminary AR D70 Overview AR Template (empty) (May 2022) Overview AR Template (including instructions) (January 2024) Quality (January 2017) Non-clinical (October 2016) Clinical (January 2017) D100 CMS Comments (April 2023) D105 clock stop (March 2012) Applicant's response template (September 2023) D120 Draft AR Non-clinical (October 2016) Clinical (October [...]
In May 2020, the ICH Management Committee and the ICH Assembly both held virtual meetings for their bi-annual meetings.
The ICH M7 Q&A draft document reached Step 2b of the ICH Process in June 2020 and now enters the consultation period. Additionally, a Step 2 Informational Presentation has also been developed by the M7(R2) Maintenance EWG/IWG.