The International Council for Harmonisation (ICH) met in Lisbon, Portugal, 11-16 June 2016...

Variation eAF: Due to an unexpected technical issue the publication of the updated version of the form is postponed to early next week. The hotfix version will be made available as soon as possible during the week commencing 27th June 2016.

CMDh SOP on the processing of PSUR single assessment for nationally authorised products (May 2016) [Track version]

A Question and Answer (Q&A) document on Membership and Observership can now be found on the ICH website. The Q&A document aims to address questions of potential applicants interested in ICH Membership and Observership.

The Questions and Answers Document of the ICH S3A Guideline on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure reached Step 2b of the ICH Process in May 2016 and now enters the consultation period (Step 3).

All EMA IT systems temporarily unavailable from 06:00 on Saturday 16 April to 06:00 on Sunday 17 April 2016 (UK time) due to essential maintenance. The Annex 1 - A guide to the filenaming convention for eSubmission document describing the detailed filenaming conventions for submissions via eSubmission Gateway has been updated with new, additional filenaming [...]

In April 2016, further to the update of the Regulatory Notice Document (RND) in January 2016, the S1 Expert Working Group has completed a Prospective Evaluation Period Status Report.

The Q3D Training Modules 0-7 (Module 0: Overview; Modules 1-7 on key safety and quality topics) can now be found on the ICH website.

Version 1.20 of the eAFs will become available on 15 April 2016. To support the release of this next version of the forms: New versions of the eAF Data Exchange Standards (DES) and schemas have been released and can be found here. We are organising User Acceptance Testing (UAT) of version 1.20 of the eAFs. [...]

The EMA is extending the use of XML delivery files for all submissions excluding the Veterinary PSURs and Maximum Residue Limit (MRL) from 23 May 2016. A Statement of Intent on the extended use of XML delivery files for all submissions via the eSubmission Gateway/Web Client is now availa