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

RifabutinEnd of procedure: 20/08/2025Date of publication: 17/12/2025

Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025

Levothyroxine / LiothyronineEnd of procedure: 30/07/2025Date 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.

The Cell and Gene Therapy Discussion Group, which was established in May 2023, has just published its recommendations paper, Recommendations with Regard to Future Advanced Therapy Medicinal Products-related Guidelines.

RELATED DOCUMENTS EMA has issued guidance documents aligned with the revised Variations framework, which also apply to MRP/DCP procedures:  EMA Post-authorisation guidance on classification of changesQ&A regarding medicines used in combination with medical devices and consultation procedures by notified bodiesQ&A on novel or complex manufacturing in Q.II.b.1 and Q.II.b.4Q&A on skip or periodic testingGuidance on [...]

Botox (botulinum toxin type A)End of procedure: 04/11/2023Date of publication: 27/11/2025