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
Cleviprex (clevidipine)End of procedure: 30/07/2025Date of publication: 27/11/2025
The International Council for Harmonisation (ICH) confirmed two new Members and two new Observers at the 51st ICH Assembly in Singapore.
The Assembly of the International Council for Harmonisation (ICH) met in person on 18-19 November 2025 in Singapore, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
Riamet (artemether / lumefantrine)UK/W/0096/pdWS/001End of procedure: 06/02/2017Date of publication: 03/04/2017SE/W/0032/pdWS/001End of procedure: 21/07/2021Date of publication: 03/05/2023SE/W/0032/pdWS/002End of procedure: 06/02/2024Date of publication: 02/05/2024SE/W/0032/pdWS/003End of procedure: 29/07/2025Date of publication: 23/10/2023SE/W/0032/pdWS/004End of procedure: 29/07/2025Date of publication: 23/10/2023
Xalatan / Latanoprost Viatris (latanoprost)End of procedure: 18/09/2024Date of publication: 23/10/2025
Post-Brexit (October 2025)
Following the launch of optional use in February 2025 and the start of the recommended use in May 2025, it is now strongly recommended to use of the PLM Portal web-based eAF for all MRP/DCP and purely national variations, where possible. This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations. Please note that [...]