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.
The ICH E9(R1) Addendum to Defining the Appropriate Estimand for a Clinical Trial/Sensitivity Analyses reached Step 2b of the ICH Process in August 2017 and now enters the consultation period.
Common Repository will be unavailable between 07:00 and 09:00 on Wednesday, 30 August 2017 due to essential maintenance. If you have any questions, please contact the IT Service Desk.
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.
Impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations
In November 2016, the ICH endorsed a new topic on Optimisation of safety data collection. This guideline will provide a harmonised guidance on when it would be appropriate to use a targeted approach to safety data collection in some late-stage pre-marketing or post-marketing studies, and how such an approach would be implemented.