The ICH E18 Guideline reaches Step 4 of the ICH Process
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 reaches Step 4 of the ICH Process
The ICH Q11 Q&A reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5).
ICH S5(R3) revised Guideline reaches Step 2b of the ICH Process
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.
ICH E9(R1) Addendum reaches Step 2b of the ICH Process
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.
Essential maintenance to computer applications on Wednesday morning
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.
ICH Training Pilot Programmes Available
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…
Impact of EU-USA Mutual Recognition Agreement on marketing authorisation applications and relevant variations
New ICH E19 Guideline in development on Optimisation of Safety Data Collection
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.
A defect in section 1.4 of the MAA veterinary eAF, affecting the MRL substances
A defect in section 1.4 of the MAA veterinary eAF, affecting the MRL substances has been detected and subsequently fixed. New version v.1.21.0.1 of the MAA veterinary form and the updated release notes are now available. Defects in section 1 and 3 of the Renewal eAF, affecting the MA Numbers fields and the overages field [...]
Symbicort pMDI (budesonide and…
Symbicort pMDI (budesonide and formoterol fumarate dihydrate) End of procedure: 28/03/2017 Date of publication: 05/07/2017