ICH Transparency: New Info on Funding, Expert Working Groups
Posted 17 October 2017 | By
The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.
"While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play," ICH said.
According to the new funding information, ICH’s budget for 2017 totaled about $1.7 million, with the bulk of that funding going to staff, operating costs and the biannual meetings. Membership fees ranged from about $20,000 for industry and regulatory members to about $238,000 for founding regulatory and industry members.
In addition, ICH announced that its draft ICH E9(R1) Addendum on defining appropriate estimands for a clinical trial/sensitivity analyses has been published for consultation.
"The proposed addendum to the 1998 guideline on Statistical Principles for Clinical Trials seeks to promote harmonised standards on the choice of estimand in clinical trials and define an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data," ICH said.
Another draft guideline published for consultation is ICH S5(R3) on the detection of toxicity to reproduction for human pharmaceuticals.
"The revision proposes efficiencies in the conduct of reproductive toxicity studies, including novel models to complement traditional methods when warranted," ICH said. "The proposal seeks to enhance human risk assessment, while also reducing potentially animal use. The revision uses experience gained since the last revision in 2000 with the testing of pharmaceuticals as well as developments in scientific, technological and regulatory knowledge."
In addition, ICH says it adopted ICH E11(R1) on pediatric drug development, a new harmonized E18 guideline on collecting genomic information and the ICH Q11 Q&A document on additional clarity and to promote the convergence for selecting and justifying starting materials and what should be provided in marketing authorization applications and master files.