ICH is inviting public review and comment on a reflection paper on Good Clinical Practice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct.
This version delivers new functionality to create delivery files for MRL and veterinary PSUR submissions as well as functionality to create delivery files for human PASS 107o submissions, PASS 107n, PASS 107o and PASS 107q submissions for Nationally Authorised Products and submissions for Ancillary Medicinal Products in medical devices.
The ICH Q3C(R6) Guideline reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5).
The Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice (GCP) reached Step 4 of the ICH Process in November 2016.
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period.
Information on how to submit electronic applications within MRP, DCP and National procedures via the CESP portal is found on the CESP (hma.eu) website.
The ICH MedDRA Management Board met in Osaka, Japan on November 5-6, 2016 and announces reductions in Subscription Rates for MSSO Subscribers....
The International Council for Harmonisation (ICH) met in Osaka, Japan on 5-10 November 2016.
The ICH E11(R1) draft Addendum Guideline on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 2b of the ICH Process in October 2016 and now enters the consultation period (Step 3).
In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers.