EMA'S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
By Karl-Heinz Loebel, Director & Principal Consultant Of Regulatory Operations, Cencora PharmaLex
The European Medicines Agency (EMA) is getting ready to implement the eCTD 4.0 standard in the pharmaceutical industry. In this article, we will explore the key developments, including the recently released draft EU eCTD 4.0 Implementation Guide and the upcoming pilot programs.
The new guide, together with the ICH eCTD 4.0 V1.5 Implementation Guide, explains the structure and functionalities of eCTD 4.0. The guide primarily focuses on Centralized Procedure (CP) submissions to EMA, with a plan to roll it out for national agencies later. To ensure a smooth transition, EMA conducted a workshop in March to address potential gaps and gather industry feedback. A key theme that emerged is the need for clarity on document replacement, reuse, and the use of dedicated eCTD 4.0 review tools.
This article outlines the planned eCTD 4.0 implementation timeline, including voluntary technical and business pilot programs that are expected to begin this year. Industry participants are encouraged to familiarize themselves with the new standard and consider participating in the pilot programs.
Get unlimited access to:
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.
Cencora PharmaLex
MORE FROM Cencora PharmaLex
-
Exploring The Journey To eCTD 4.0
eCTD 4.0 promises to streamline regulatory submissions and enhance global collaboration. However, implementation challenges and evolving regulatory landscapes pose significant hurdles. -
Rebuttal: eCTD 4.0: More, Sooner!
Examine the complexities of targeted medicines and the recent discussion in the industry surrounding eCTD 4.0. -
eCTD Brief: The Deep Dive Into Electronic Submissions
The ICH Common Technical Document (CTD) provides a common format for marketing authorization submissions in all ICH markets, and use of this format is now mandatory. Read in this blog about the... -
The Crucial Role Of Scientific Regulatory Writing For Drug Approval
Scientific regulatory writing is a cornerstone of drug approval. Learn how crafting clear, accurate, and compliant documentation helps ensure timely and efficient submissions. -
Health Canada Revises Validation Rules For eCTD Format
This blog explains Health Canada revised validation rules for regulatory transactions in the electronic Common technical Document (eCTD) format, which are applicable since March 30th, 2019.