PSUR webinars
PSUR recorded webinar training sessions and updated presentation slides for Marketing Authorisation Holders and National Competent Authorities users are available here.
ICH M4E(R2) Guideline reaches Step 2b of the ICH Process
The ICH M4E(R2) Guideline reaches Step 2b of the ICH Process in August 2015 and now enters the consultation period (Step 3).
Version 01.03 of the PSUR Repository
• Version 01.03 of the PSUR Repository is now available for both MAHs and NCAs. This new release provides change requests further enhancing the system and fixes defects identified during the pilot phase. The updated system release notes and MAH and NCA user guides on the PSUR respository page.
CMDh guidance for Declaration form submission DDPS already approved by a competent authority (June 2011) [Track version]
CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System (May 2023) [Track version]
ICH E6(R2) Integrated Addendum reaches Step 2b of the ICH Process
The Integrated Addendum of the ICH E6 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3). The E6 Integrated Addendum has been developed to complement the harmonised ICH E6 Guideline which was finalised in May 1996.
ICH Q3C(R6) Revised PDE for Methyl isobutyl ketone and New PDE for Triethylamine
The ICH Expert Working Group (EWG) responsible for the maintenance of the Q3C Guideline has revised the Permitted Daily Exposure (PDE) for Methyl isobutyl ketone (MIBK) which was listed in ICH Q3C(R5) as a Class 3 solvent (“solvents with low toxic potential”).
eCTD EU Module 1 v3.0
The eCTD EU Module 1 v3.0 has been released for public consultation until 14.9.2015 and the updated version can be found here. The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) invites all pharmaceutical companies, vendors of eCTD building and reviewing tools, and competent authorities to send comments. Please complete the relevant [...]
Follow in details the main decisions taken by the ICH SC in June 2015
A comprehensive report of the last ICH meeting that was held in Fukuoka, Japan on 10-11 June 2015 is now available on the ICH website under the SC Reports page.
ICH M7(R1) Addendum reaches Step 2b of the ICH Process
The Addendum of the ICH M7 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3).
eAF v 01.18
• New versions of all electronic Application Forms (eAF v. 01.18) are now available and can be found here. These versions provide usability improvements to the existing forms. The new versions of the forms replace the current version of eAF v. 01.17 after a transitional period of 1 month on 3 August 2015 and should [...]