At the Osaka 2016 meeting, the ICH Management Committee endorsed a Pilot Programme for 2017 in which the ICH Training Subcommittee would partner with a small group of training providers to organise and deliver high quality programmes based upon the scientific and regulatory principles outlined in ICH Guidelines.
In May/June 2017, the ICH Assembly and Management Committee met in Montreal, Canada, for their biannual meeting.
An updated version of the eSubmission Gateway Web Client will become available on Saturday 23rd of September 2017. The eSubmission Gateway Web Client update will introduce an updated user interface with some updated functionality. The user guide 'How to send submissions via the Web Client' has been updated and is available. Romania is now using [...]
Essential maintenance to EMA computer applications affecting PSUR Repository/eSUB UI/eSubmission Gateway on Saturday, 23 September PSUR/eSubmissions Web User Interface (to create the delivery file) will be intermittently unavailable between 09:00 and 14:30 on Saturday, 23 September due to essential maintenance. The eSubmission Gateway will be also unavailable between 09:00 and 17:00 (UK time) due to [...]
The Common Repository has been extended to include all human Referral submissions from 1st September 2017. The use of the Common Repository for human Referral submissions will become mandatory for all NCAs on 1st of December 2017. There should be no referral submissions directly to any NCAs from 1st of December 2017 as these will [...]
Please note that the all support calls relating to eSubmissions systems, such as eAF, must be sent via the EMA service portal. The email addresses 'eAF@ema' and 'eCTD@ema' are no longer in use and queries sent to these email addresses will not be processed.
The ICH E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5).
The ICH E18 Guideline on Genomic Sampling and Management of Data reached Step 4 of the ICH Process in September 2017 and now enters into the implementation period (Step 5).
The ICH Q11 Q&A reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5).
The ICH S5(R3) on Detection of Toxicity to Reproduction for Human Pharmaceuticals reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.