Últimas noticias
Botox (botulinum toxin type A)End…
Botox (botulinum toxin type A)End of procedure: 04/11/2023Date of publication: 27/11/2025
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)
ICH Q3E Step 2 Presentation Now Available on the ICH Website
In follow up to the publication of the ICH Q3E draft “Guideline for Extractables and Leachables” in August 2025, the Q3E EWG has also prepared a Step 2 informational presentation.
ICH E11A EWG Training Material Now Available on the ICH Website
The ICH Secretariat is pleased to announce the release of E11A Pediatric Extrapolation Training Module 1 - Case Example: Development of a hypothetical TNF-alpha inhibitor "Drug X" for the treatment of polyarticular juvenile idiopathic arthritis [...]
HavrixEnd of procedure:…
HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025
Pheniramine maleate, naphazoline…
Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date of publication: 25/09/2025
2025, Q1-Q2 – Statistics for New…
2025, Q1-Q2 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
The ICH M14 Guideline reaches Step 4 of the ICH Process
The ICH M14 Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines” has reached Step 4 of the ICH Process on 04 September [...]
Member: Helen VellaAlternate:…
Member: Helen VellaAlternate: Paula Cardona Xuereb Awtorità dwar il-MediċiniSir Temi Zammit BuildingsMalta Life Sciences ParkMT-SGN 3000 San Gwann
Member: Andrzej…
Member: Andrzej CzeslawskiAlternate: Pawel Pawlowski Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsAl. Jerozolimskie 181CPL-02-222 Warszawa
Member: Marta…
Member: Marta Marcelino Alternate: Rui Pedro da Costa Vilar INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA
Member: Christin…
Member: Christin OlofssonAlternate: Adam Andersson Medical Products AgencyDag Hammarskjölds väg 42SE-751237 UPPSALA
Member: Vlasta Zavadova Office of…
Member: Vlasta Zavadova Office of HealthÄulestrasse 51LI-9490 Vaduz