The minutes of the ICH Management Committee and ICH Assembly meetings held in Singapore at ICH51 have been published. These documents summarise the decisions taken and topics discussed during the face-to-face biannual meetings, which took place in November 2025.
Meeting 27-29 January 2026: Agenda
Three ICH Expert Working Groups have issued an updated document package, a mapping document and training materials, respectively, associated with three technical Guidelines: E2B(R3) - Individual Case Safety Report Specification; M4Q(R2) - The Common Technical Document; and E6(R3) - Good Clinical Practice.
As a follow-up to the November 2025 endorsement and publication of the ICH E22 draft Guideline on General Considerations for Patient Preference Studies, the E22 Expert Working Group has issued an informational presentation and training materials.
Marta Marcelino INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA
Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025
Levothyroxine / LiothyronineEnd of procedure: 30/07/2025Date of publication: 17/12/2025
RifabutinEnd of procedure: 20/08/2025Date of publication: 17/12/2025
CGTDG - Recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines The Cell and Gene Therapy Discussion Group (CGTDG), which was established in May 2023, has provided as an output of its 2-year remit, Recommendations with regard to future Advanced Therapy Medicinal Products (ATMPs) Related Guidelines.