Últimas noticias
eCTD published validation criteria
An error had been detected in the eCTD published validation criteria. The updated version with the correc md5 checksums is available here.
User Acceptance Testing (UAT)
From 23 May 2016 it will be possible to use XML delivery files instead of the existing filenaming conventions for number submission types via eSubmission Gateway/Web Client. We would like to involve industry representatives in [...]
System maintenance work
MAHs are advised that due to system maintenance work the product refresh for the PSUR Repository will be stopped during the following planned dates, which are currently: 11th March to 18th March 2016 22nd March [...]
Version 01.19.0.2 of the eAFs
Version 01.19.0.2 of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms. If you [...]
The ICH M7(R2) Introductory Training Presentations are now available on the ICH website
The ICH M7(R2) Guideline on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has reached Step 4 of the ICH Process in April 2023.
electronic Application Forms
New versions of the electronic Application Forms (eAF v. 01.19) are now available and can be found here. These versions provide usability improvements to the existing forms and reflect the changes in the NtA application [...]
Fluarix Tetra (Influenza virus…
Fluarix Tetra (Influenza virus (inactivated, split) of each of 4 strains (two A subtypes and two B lineages)) End of procedure: 31/03/2023 Date of publication: 02/16/2023
Prazosin End of procedure:…
Prazosin End of procedure: 02/04/2023 Date of publication: 02/16/2023
Meeting with Interested Parties -…
Meeting with Interested Parties - 31 May 2023 Agenda Presentations CMDh - Multilingual Labelling in MRP/DCP CMDh - Renewal improvements CMDh - Availability of updated PI following safety reviews Medicines for Europe Europharm SMC
Added in June 2023 1 June NEW…
Added in June 2023 1 June NEW - April 24-25 minutes
PSUR bulletin
The PSUR bulletin for the week commencing 29 June 2015 is now available.
ICH E6(R3) draft Guideline reaches Step 2 of the ICH process
The ICH E6(R3) draft Guideline on “Good Clinical Practice (GCP)” has reached Step 2 of the ICH process on 19 May 2023.
Added in May 2023 22 May NEW -…
Added in May 2023 22 May NEW - 23-25 May agenda 3 May UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected” UPDATE - CMDh practical guidance [...]
The ICH M7(R2) Guideline reaches Step 4 of the ICH Process
The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline [...]
The ICH Q9(R1) Introductory Training Presentation is now available on the ICH website
The ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process in January 2023.
The ICH S12 Guideline reaches Step 4 of the ICH Process
The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023.
CMDh letter to MAHs of…
CMDh letter to MAHs of tenofovir disoproxil-containing medicinal products (February 2023)
CMDH PRESS RELEASES 2023
Report from the meeting held on 23-25 May 2023 Report from the meeting held on 24-25 April 2023 Report from the meeting held on 28-30 March 2023 Report from the meeting held on 21-22 February [...]
The ICH M13A draft Guideline presentation available now on the ICH website
A Step 2 Informational Presentation has been developed by the M13 Expert Working Group, in follow up to the ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of [...]
The ICH Q13 Introductory Training Presentation is now available on the ICH website
The ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process on 16 November 2022.