The Electronic Common Technical Document (eCTD) v4.0 is currently being outlined by regulatory authorities for its implementation. Different authorities have published their own guidelines, while voluntary and mandatory use of eCTD 4.0 varies from authority to authority. But what is eCTD 4.0, and where are its differences from the current eCTD standard?
eCTD is an electronic format used for submitting applications, amendments, supplements, and reports to drug-related authorities. It provides detailed information on medicinal products to these authorities for the purpose of obtaining approval to market the product.
eCTD 4.0 is the latest format to be introduced to the life sciences and pharmaceutical industry. It will take over from the current version (v3.2.2) and offer users access to new capabilities. Some of these capabilities include:
Document and meta-data reuse
Automation of administrative processing
Submission of content relevant to more than one dossier
Implementation of the latest legal requirements (no modification of dossier structure required)
The ability to correct or edit information easily
Group documents per CTD section
Identify submission content quickly for additional processing
Transition content from v3.2.2 to v4.0
eCTD v4.0 is based on the HL7 (Health Level 7) v3 RPS (Regulated Product Submission) messaging standard. Since the support for HL7 v3 may end before eCTD v4.0 is fully implemented, companies may question the long-term viability of the HL7 v3 (RPS) messaging standard in favor of changing to FHIR (Fast Healthcare Interoperability Resources).
The FHIR implementation has rapidly expanded in the healthcare domain in the past 1-2 years. However, this standard misses some regulatory concepts. It would need much substantial work to remodel towards eCTD v4.0 requirements if FHIR was implemented. At the ICH-M8 Teleconference in April 2019, the ICH recommended moving forward with eCTD v4.0 implementation based on the HL7 v3 RPS standard. ICH will continue with RPS as only minimal support from HL7 v3 is anticipated by ICH as necessary.