The CMDh has introduced a Request Form for an MRP/RUP procedure available for the National Competent Authorities (NCA). Due to the different organisations and thereby also different working procedures for the approved medicinal products in member states, the Request form may need to be adapted at national level and is not mandatory for the NCAs to use. The Request Form is published [...]
Template Assessment Report MRP Overview (October 2020, correction February 2024)
Further to the ICH Q3D(R2) draft document reaching Step 2b of the ICH Process, the Step 2 Informational Presentation developed by the ICH Q3D(R2) Maintenance EWG has been finalised.
Procedural Advice on Repeat Use (January 2025) [Track version]
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.