Últimas noticias
Updated Technical Documents Issued by ICH Expert Working Groups for Three Guidelines
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 [...]
Presentation and Training Materials Now Available for Draft Guideline on Patient Preference Studies
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 [...]
Marta Marcelino INFARMEDParque de…
Marta Marcelino INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA
Nebivolol hydrochloride /…
Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025
RifabutinEnd of procedure:…
RifabutinEnd of procedure: 20/08/2025Date of publication: 17/12/2025
Levothyroxine / LiothyronineEnd of…
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
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 [...]
Recommendations for Future Guidelines Related to Advanced Therapy Medicinal Products
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…
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 [...]
Botox (botulinum toxin type A)End…
Botox (botulinum toxin type A)End of procedure: 04/11/2023Date of publication: 27/11/2025
Cleviprex (clevidipine)End of…
Cleviprex (clevidipine)End of procedure: 30/07/2025Date of publication: 27/11/2025
ICH Assembly Welcomes New Members and Observers
The International Council for Harmonisation (ICH) confirmed two new Members and two new Observers at the 51st ICH Assembly in Singapore.
Press Release: ICH Assembly Meeting, Singapore, 2025
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 [...]
Riamet (artemether /…
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
Following the launch…
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 [...]
Xalatan / Latanoprost Viatris…
Xalatan / Latanoprost Viatris (latanoprost)End of procedure: 18/09/2024Date of publication: 23/10/2025
Post-Brexit (October 2025) …
Post-Brexit (October 2025)
ICH E6(R3) Module 1 Training Now Available on the ICH Website
The ICH Secretariat is pleased to announce the publication of the following training module, now available in the ICH Training Library: Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline - Module 1: Introduction [...]
The ICH E2D(R1) Guideline reaches Step 4 of the ICH Process
The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now [...]
PAR update (December 2009)
PAR update (January 2016)