Últimas noticias
Request for Proposal for Technical/Regulatory Writing Services
ICH is launching a request for proposal for technical/regulatory writing services to support the drafting activities associated with ICH guideline development in support of ICH EWG Member and Observer representatives.
Montelukast Date of…
Montelukast Date of publication: 22/11/2023
Press Release: ICH Assembly Meeting, Prague, Czech Republic, October/November 2023
The Assembly of the International Council for Harmonisation (ICH) met in-person on 31 October & 1 November 2023, in Prague, Czech Republic in parallel of meetings of 16 Working Groups, and preceded by meetings of [...]
Added in November 6 November …
Added in November 6 November NEW - 7-8 November 2023 CMDh agenda
Vancomycin hydrochloride Date…
Vancomycin hydrochloride Date of publication: 18/10/2023
Paricalcitol Date of…
Paricalcitol Date of publication: 18/10/2023
Ipratropium bromide Date of…
Ipratropium bromide Date of publication: 18/10/2023
Itopride Date of publication:…
Itopride Date of publication: 18/10/2023
Lamotrigine Date of…
Lamotrigine Date of publication: 18/10/2023
Metoclopramide Date of…
Metoclopramide Date of publication: 18/10/2023
ICH Q9(R1) Quality Risk Management Training Materials now available on the ICH Website
The ICH Secretariat is pleased to announce the publication of Q9(R1) Quality Risk Management Training Materials.
The marketing authorisation holder…
The marketing authorisation holder (MAH) is responsible to keep its product information updated in line with current scientific knowledge or recommendations. The MAH is responsible for regularly monitoring relevant sources of new information and recommendations [...]
Member: Heili Tikk Alternate:…
Member: Heili Tikk Alternate: Kairi Laius State Agency of Medicines 1 Nooruse Street EE-50411 TARTU
Added in October 4 October …
Added in October 4 October UPDATE - CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and PL in order to provide information about the medicinal product
Oxycodone …
Oxycodone End of Procedure: 24/03/2021 Date of Publication: 27/09/2023
Member: Vacant Alternate: Mathilde…
Member: Vacant Alternate: Mathilde Geynet-Kovacs Agence nationale de sécurité du médicament et des produits de santé (ANSM) 143-147 Bvd Anatole France FR-93285 SAINT-DENIS CEDEX
Issue with eSubmission Gateway and its infrastructure
New version 1.24.0.1 of all four eAFs is now available to allow the users a short transitional period before the start of the mandatory use of the form. The changes in this version of the [...]
eAF v1.24.0.0 release milestone plan and updated release schedule for eAF now available
An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available. Version 1.24.0.0 of all the 4 electronic Application Forms (eAFs) is planned for release in September 2020 with [...]
Weekend Maintenance
Users should be aware that due to essential maintenance work on EMA's infrastructure, most of EMA's computer applications, including most eSubmission systems will experience downtime between the hours of 18:00 on Friday, 17th July and [...]
Computer application maintenance
Essential maintenance work will be carried out to all eSubmission applications as part of EMA's computer application maintenance work this weekend. As a result, eSubmission systems will be intermittently unavailable between 10:00hrs and 13:00hrs of [...]