eCTD Industry Update (1st August 2023)
EMA 27/07/2023 PRIME: priority medicines(updated) 26/07/2023 Clinical Trials Information System (CTIS) bitesize talk: Part I-only applications and Part II requirements in CTIS, Online, 15:30 – 17:00 Amsterdam time (CEST), from 30/08/2023 to 30/08/2023 19/07/2023 Big data(updated) 19/07/2023 The use of Artificial Intelligence (AI) in the medicinal product lifecycle 19/07/2023 Multidisciplinary: artificial intelligence (AI) 19/07/2023 News […]
eCTD Industry Update (17th July 2023)
EMA 13/07/2023 Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 (updated) 12/07/2023 Other: Guide to information on human medicines evaluated by European Medicines Agency: what the Agency publishes and when (updated) 12/07/2023 Other: Annex I – Guidance document on how to approach the protection of […]
eCTD Industry Update (13th July 2023)
EMA PRIME: priority medicines (updated) Other: European Medicines Agency guidance for applicants seeking access to PRIME scheme (updated) Referrals document: Nitrosamines EMEA-H-A5(3)-1490 – Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (updated) Regulatory and procedural guideline: European Medicines Agency […]
eCTD Industry Update (19th June 2023)
EMA Clinical Trials Information System (CTIS): Information day , Online, 13:30- 17:30 Amsterdam time (CET), from 17/10/2023 to 17/10/2023 EudraVigilance and Signal Management information day , European Medicines Agency, Amsterdam, the Netherlands, 09:30-17:00 CET, from 21/11/2023 to 21/11/2023 European Medicines Agency practical guidance on the application form for centralised type IA and IB variations (updated) eSubmissions (eCTD) Updated […]
eCTD Industry Update (5th June 2023)
EMA Regulatory and procedural guideline: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 (updated) Human variations electronic Application Form (eAF) & Product Management Service (PMS) Q&A clinics – Session 1 , Online, 15:00 – 15:30 Amsterdam time (CET), from 15/06/2023 to 15/06/2023 Human […]
eCTD Industry Update (2nd May 2023)
EMA Template or form: CHMP protocol assistance scientific advice briefing document template (updated) Newsletter: News bulletin for small and medium-sized enterprises – Issue 58 Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes / Clean Version (updated) Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised […]
eCTD Industry Update (25th April 2023)
EMA Regulatory and procedural guideline: IRIS guide to registration and RPIs (updated) Template or form: Template for sections A to E for the scientific part of the application for orphan designation (updated) eSubmissions (eCTD) Updated PLM Portal eAF timeline now available Please find an updated version of the PLM Portal eAF Human Variations Forms timeline. […]
eCTD Industry Update (20th March 2023)
EMA: Newsletter: CTIS newsflash – 17 March 2023 eSubmissions (eCTD): 17-03-2023 Common Repository Go-Live on 20th of March 2023 (relevant for NCAs only) We are pleased to inform you that the next version of the Common Repository introducing the ‘Basic Authentication’ is going live on the 20th of March 2023 (originally planned for the 14th […]
How to fix common eCTD validation issues
As this revision history proves, the FDA updates its specifications for eCTD validation criteria continually, a fact that makes it extremely difficult to keep up with the changes and so easy to miss an update. Whilst eCTD submission specialists like us are here to bridge the gap between organisations preparing eCTD documents and the authorities receiving them, […]
Are eCTDs mandatory?
eCTDs are no new thing. This would-be global standard was launched in 2003 within the regulatory health industry to ensure both technical and regulatory requirements were met with the effectiveness and efficiency that technology allowed. Since then, the use of electronic common technical documents (eCTDs) has snowballed to unlock several advantages, including financial benefits, for organisations looking to […]
