ICH: Press Release ICH-Assembly Meeting

The ICH published a press release on June 20, regarding a face-to-face meeting on June 12 and 13, 2023, in Vancouver, Canada. Meetings of 14 working groups, the ICH Management Committee and the MedDRA Management Committee were also held during that time.

New Areas of ICH Harmonisation

Three new areas of harmonisation were defined at the meeting:

• “General Considerations for Patient Preference Studies” – Efficacy guideline with considerations for a systematic approach to planning, conducting, analyzing, and processing patient preference studies when they contain important advanced information for evaluating products or inform drug development and related decisions.
• “Nonclinical Safety Studies for Oligonucleotide-based Therapeutics” – Safety Guideline that communicates regulatory requirements for non-clinical safety evaluations of various oligonucleotide-based treatment options through general understanding.
• “Bioequivalence for Modified-Release Products” – Multidisciplinary Guideline that represents an important step towards the harmonisation of bioequivalence standards for more complex dosage forms. The harmonised elements of the M13 Guideline series are transferable.

In a later step, the starting timeframe will be defined.

Additional results of the meeting are:

• The formation of a new ICH “Cell and Gene Therapies” Discussion Group (CGTDG), providing a technical communication forum for issues related to ICH harmonisation efforts in the area of CGT products.
• A new ICH Reflection Paper for the “International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines”.
• They noted significant milestones since the last ICH meeting, for example the adoptation of the revised ICH Q9 (R1) Guideline on “Quality Risk Management” in January 2023.

The press release also states that the African Authority EDA (Egypt) has joined ICH as a Member and NAFDAC (Nigeria) as an ICH Observer.

Source

ICH: Press Release