Últimas noticias
ICH Training Library Sees Addition of New Materials Covering 11 Harmonised Guidelines
ICH has recently published newly developed training materials for four ICH harmonised guidelines, a two-guideline Q&A, and the principles and concepts governing a group of five ICH Quality Guidelines.
Pyridoxine hydrochloride/lysozyme…
Pyridoxine hydrochloride/lysozyme hydrochlorideDate of publication: 23/09/2026
Iberogast Select / Iberogast…
Iberogast Select / Iberogast BalanceDate of publication: 23/09/2026
Revised Q&As for ICH E14 and ICH S7B provide updated implementation support
ICH has published the updated ICH E14/S7B Questions & Answers (R1) to provide clarifications related to the clinical and nonclinical assessment of QT/QTc prolongation and proarrhythmic risk.
Alternate: Sandra…
Alternate: Sandra SchmidtPaul-Ehrlich-Institut (PEI)Paul-Ehrlich-Straße 51-59D-63225 LANGEN
ICH and ISoP Sign MOU to Advance Global Awareness and Adoption of Harmonised Pharmacovigilance Requirements
ICH and ISoP have signed a Memorandum of Understanding to formalise their strategic collaboration to strengthen global awareness, recognition and adoption of ICH Guidelines, with a focus on pharmacovigilance, medication safety and MedDRA, a standardised [...]
MedDRA Version 29.1 released in English
MedDRA Version 29.1 was released today in English. All 26 language translations will be available on 15 September 2026.
Updated support package published for ICH M8: Electronic Common Technical Document (eCTD)
The ICH M8: Electronic Common Technical Document (eCTD) Implementation Working Group has issued updates to multiple support materials for eCTD v4.0 which are available for download: the Implementation Guide Package, the Controlled Vocabulary Package and [...]
2026 (Jan-Jun) – Statistics for…
2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
ICH E6(R3): Good Clinical Practice Annex 2 Adopted and Published
The International Council for Harmonisation (ICH) recently adopted Annex 2 of ICH E6(R3): Good Clinical Practice, concluding the revision of this essential ICH Guideline.
Updated eCTD v4.0 Timeline and Ongoing Pilots
EMA updated the eCTD v4.0 implementation roadmap, announcing strongly recommended use for new CAP MAAs from Q1 2027, mandatory use from Q1 2028, and continued pilot activities.
PLM Portal eAF Version 1.2.1.14 Release Notes Published
Release notes for version 1.2.1.14 are now available, covering bug fixes, the Annual Update checkbox functionality and support for FHIR XML version 2.2.6.
Doxazosin mesilate, finasteride…
Doxazosin mesilate, finasteride (MIP Pharma) / Doxazosin mesilate, finasteride (Viatris)Date of publication: 03/07/2026
Implementation Timeline for Human and Veterinary MAA eAF v1.28.0.0
EMA published mandatory use timelines for Human and Veterinary MAA eAF version 1.28.0.0, including CAP submissions from July 2026 and wider NCA adoption through 2027.
PLM Portal FHIR XML Upgrade to Version 2.2.6
EMA announced a FHIR XML upgrade introducing support for the Annual Update notification while maintaining compatibility with the existing FHIR package.
Veterinary MAA eAF v1.28.0.0 Available for Testing
EMA released Veterinary MAA eAF version 1.28.0.0 for broader user testing, introducing VMP Regulation alignment, SRP support and improvements based on the ISO IDMP data model.
Human MAA eAF v1.28.0.0 Mandatory Use Update
EMA confirmed that Human MAA eAF version 1.28.0.0 must be used for new CAP MAA submissions from 28 July 2026 and announced a future wider rollout for other submission types.
Key Outcomes of Biannual ICH Assembly Meeting
The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in person on 2–3 June 2026 in Rio de Janeiro, Brazil for its biannual meeting. The ICH [...]
Human MAA eAF v1.28.0.0 Available for Testing
EMA released Human MAA eAF version 1.28.0.0 for user testing, introducing structural enhancements aligned with the ISO IDMP data model and improved representation of medicinal product information.
Vaccin rabique Pasteur / Verorab…
Vaccin rabique Pasteur / Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))End of procedure: 10/04/2026Date of publication: 27/05/2026