The ICH M9 draft Guideline on Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and has entered the public consultation period.
The ICH E9(R1) Step 2 Training Material was produced by the ICH E9(R1) Expert Working Group to accompany the Draft ICH E9(R1)
Reminder concerning the Common Repository: applicants are reminded that for procedures involving only Centrally Authorised products, submission should be done only once, via the EMA eSubmission Gateway. No additional submission should be done via CESP, CD or DVD, as National Competent Authorities have now access to the Common repository. For further details, please consult the [...]
The ICH Q3D(R1) Revision to the Q3D Cadmium Inhalation PDE reached Step 2b of the ICH Process in May 2018
In June 2018, the ICH Assembly and Management Committee met in Kobe, Japan for their bi-annual meeting.
At its meeting in Kobe, Japan in June 2018, the ICH Assembly approved the 2017 Annual Report of the ICH Association.
Infanrix (Adsorbed Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed Pertussis antigens (Pertussis toxoid, Filamentous Haemagglutinin, Pertactin)) End of Procedure: 07/06/2018 Date of Publication: 03/08/2018
The ICH S9 Questions and Answers (Q&As) on the Nonclinical Evaluation for Anticancer Pharmaceuticals, reached Step 4 of the ICH Process in April 2018.
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), are intended to provide additional clarification
This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of [...]