Current eCTD Implementation Status

World-wide Health Authorities continuously updating requirements and standards for electronic submission, so it much necessary to keep updated your self with current specifications to make eCTD submission 100% error free and compliant.

Current eCTD Module 1 Specification, DTD, and Validation Criteria Version with Update

Sr# Country M1 Spec DTD Validation Criteria Current Update
1. USA

(USFDA)

v1.3 / v2.3

(both are acceptable)

v2.01 / v3.3

(both are acceptable)

v3.8 All type of application and submission must be eCTD format only except.

  • All submissions to noncommercial INDs
  • All submissions DMF Type III (Packaging Material)
  • Certain Positron Emission Tomography (PET) Drugs and Type II DMF Submissions (supporting PET and noncommercial INDs submission)
  • All above submission must submit in alternative electronic format (e.g., PDF files following the CTD structure).
2. Europe

(EU-EMA)

v3.0.3 v3.0.1 v7.1 From January 1, 2020, eCTD has become mandatory for all CEP applications (initial, notifications, revisions, and renewal applications exceptional)

  • For TSE only submissions PDF will continue to be the accepted.
3.  

Canada

(HC)

v2.2 v2.2 v.4.4 Effective January 1, 2020 all DMF must be eCTD format.

  • New Type I Master Files – Drug Substance
  • New Type II Master Files – Container Closure Systems and Components
  • New Type III Master Files – Excipients
  • New Type IV Master Files – Drug Product
4. GCC v1.5 v1.1 v1.4
  • Saudi Arabia, Oman, UAE, and Bahrain are accepting submissions in eCTD format only and Qatar, Kuwait accepting in NeeS Format also and Yemen still country specific.
5. Jordan

(JFDA)

 

v1.0.2 / v1.1

 

v1.0 / v1.1

 

v1.0 / v1.1

  • On May 01, 2020, Jordan FDA has updated the JORDAN Module 1 eCTD Specification version as 1.1 and Validation Criteria version as 1.1 and DTD V1.1, and that will come into force from January 01, 2021.
6. Australia

(TGA)

v3.1 v3.1 v3.1
  • January 2018, v3.1 eCTD specification was valid, and it has been mandated from 1 July 2018. The eCTD v3.0 versions are no more valid.
  • From July 01, 2020, TGA Sets Mandatory Deadline for Stage 3 Implementation of eCTD Format for Prescription Drug Dossier Submissions.
7. Switzerland

(SwissMedic)

v1.4 / v1.5 v1.4 / v1.5 v1.4 / v1.5
  • On 01 April 2020, the new Swiss Module 1 Specification for eCTD v1.5 has implemented. Both versions (v1.4 and v.15) will be valid from 01 April 2020 to 30 September 2020.
  • As from 01 October 2020, the Swiss Module 1 Specification for eCTD v1.5 must be used for all eCTD submissions.
  • On July 02, 2020, SwissMedic released draft implementation package for eCTD v4.0 and Swissmedic is inviting authorisation holders, software manufacturers, service providers in the regulatory affairs field, other authorities and interested parties to examine the current Implementation Package and feedback by 30 September 2020.
8. South Africa

(SAHPRA)

v3.0 v2.1 v2.1
  • The version v3.0 of the Module 1 specification is implemented on 01 May 2019. This is latest version does not update after this.
9. THAILAND (TFDA) v1.0 v1.0 v1.0
  • The Thai FDA started accepting eCTD submission in May 2015 and announced to make eCTD submissions mandatory from 2017, but till date there is no update on mandatory date.
10. Singapore

(HAS)

__ __ __
  • HAS plans to commence the development phase in 2019 to allow eCTD submissions by the end of 2020.
11. Japan

(PMDA)

v1.0 v1.0 v1.0
  • No recent update, accepting submission in Japanese languages only.
12. China

(CFDA)

Draftv1.0 Draftv1.0 Draftv1.0
  • The CDE, conducted an eCTD pilot from Nov 25 through Dec 4, 2019.  A selected number of industry companies were nominated to submit electronic submissions in eCTD format (CN v1.0 DRAFT).
13. EUEA

(Eurasian Economic Union)

__ __ __
  • From December 31, 2020, it is mandatory for New Marketing Authorizations (new MAA) to comply with the new electronic submission requirements.
  • Additionally, any follow-up submissions should align with the new format from December 31, 2025.
  • From December 31, 2020, new applicants will no longer be able to file applications as National Procedure (NP). The applications can only be submitted by Decentralized Procedure (DCP) or Mutual Recognition Procedure (MRP).
14. ICH __ v4.0 __
  • The standard – developed by the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) – is an upgraded version of the currently valid standard eCTD v3.2.2. The new standard will be introduced over the next few years; the exact timeframe has not yet been defined.
  • USA, Europe, Canada, Japan and Switzerland health authorities released their draft implementation package.

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