ICH updates on upcoming guidelines, adds new participants

Regulatory NewsRegulatory News | 03 June 2020 |  By 

The International Council for Harmonisation (ICH) on Wednesday announced the addition of a new member and observer to its ranks and updated on the progress of guidelines in development following a virtual meeting of the ICH Assembly last week held in lieu of its previously scheduled meeting in Vancouver, Canada.
At the meeting, ICH welcomed Turkey’s Medicines and Medical Devices Agency (TITCK) as a regulatory member, after having joined ICH as an observer in 2018, and Lebanon’s Ministry of Public Health (MOPH) as a new observer. The new additions bring the total for ICH members to 17 and the number of observers to 32.
ICH updated on the progress of four of its guidelines, three that reached Step 4 of the ICH process in recent months and one that reached Step 2.
The guidelines that reached Step 4 include an update to the questions and answers document for ICH’s M8 electronic Common Technical Document (eCTD) v4.0 guideline; ICH’s new S11 Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals guideline; and its S5(R3) Guideline on Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals. ICH’s Q3C(R8) guideline on residual solvents, which is being updated to include permitted daily exposures for three new inpurities, reached Step 2 of the ICH process in March.
(RELATED: ICH cancels Vancouver meeting, opens consultation on residual solvents guideline, Regulatory Focus 26 March 2020; ICH adopts S11 guideline on nonclinical safety testing for pediatric drugs, Regulatory Focus 14 April 2020).
The Assembly also said it supported work on two new topics, structured product quality submissions and a revision of the M4Q(R1) Common Technical Document (CTD) guideline.
“Work on M4Q(R1) CTD is foreseen to get underway with the establishment of an informal Working Group towards the end of 2020, with a plan to be drawn-up regarding the initiation of Structured Product Quality Submissions since this topic will be informed by work on M4Q(R1) CTD, and vice versa,” ICH said.
Additionally, the Assembly said it supports the establishment of discussion groups to flesh out the scope and approach for harmonization for two other topics: general considerations for model-informed drug development to support drug registration and ICH E4: Dose Response Information to Support Drug Registration.


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