eCTD NEWS
RECENT NEWS
Loading...
ICH: ICH electronic Common Technical Document – eCTD v4.0 CMDh: National recommendations for request to act as RMS (June 2022) MHRA: Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending –...
EMA: Regulatory and procedural guideline: Compilation of quality review of documents (QRD) on stylistic matters in product information (updated) - https://bit.ly/3xNMerv Submitting annual reports on medicine development (updated) - https://bit.ly/3MU0GSR Changing the name or address of a...
CMDh Update: Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP: Clean version: https://bit.ly/3mniGu8 Tracked version: https://bit.ly/3GZF85W Update: Practical guidance on the implementation of the Protocol on Ireland/Northern Ireland for...
eSubmissions (eCTD) DADI Project Update Human variations forms updated timeline & revised go-live scope Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details...
End of content
No more pages to load
Loading...
CMDh New - Template for Applicants to Prepare Similarity Report Update - Applicant's response document in Mutual Recognition and Decentralised Procedures for Marketing Authorisation Applications (Clean / Tracked Version) Update - RMS validation checklist for human medicinal products in DCP Update - Request for MRP/RUP / Update assessment report Update - CMDh Best...
EMA DADI PDF electronic application forms (eAF) training webinar, Online, 11:00 - 12:30 Amsterdam time (CEST), from 02/09/2022 to 02/09/2022 (updated) Organisation Management System (OMS) Trouble Shooting Session for CTIS users - September 2022, from 22/09/2022 to 22/09/2022 (updated) Clinical Trials Information System...
EMA EMA Account Management training webinar Quarterly system demo - Q3 2022 Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated)
End of content
No more pages to load
BLOGS
Loading...
GET IN TOUCH WITH ONIX TODAY!
Contact us using the form below.
If you would prefer to call or email us: +44(0) 1753 257 904 or info@onixls.com
"*" indicates required fields
SUBSCRIBE TO OUR NEWSLETTER
Join our mailing list to receive the latest news and updates from our team: