Release of SG-HSA Specification Package v1.0 for Electronic Common Technical Document (eCTD) Implementation in Singapore

1.

eCTD ID to be issued by eCTD portal 

Company can obtain a unique e-identifier (SG eCTD ID) by submitting a request through the eCTD portal for an eCTD Application. The same ID will serve as the application folder name and will be used for all sequences of this eCTD application throughout the product life cycle.

2

Introduction of a SG regional stylesheet and optional HTML file 

A regional stylesheet has been included in the specification components package. An HTML rendition of the ICH and/or Regional backbone can be provided in the eCTD folder.

3

Envelope changes

Envelope elements have been amended to include  SG-eCTD-ID with UEN and UUID removed.

4

Module 1 Heading elements

The DMF submission form has been removed as this is no longer a documentary requirement.

5

Submission type changes (14, 19)

i) Submission type 14 has been renamed as PV-EDU/RMP Materials (formerly PV-EDU/RMP Materials-N). Refer to the updated Questions and Answers on submission of post-authorisation educational/RMP materials.

ii) Submission type 19 (Submission to withdraw eCTD application) has been removed from the list of submission types. Cancellation or withdrawal of applications are activities that reside in the PRISM system. HSA will update the status of the withdrawn eCTD applications.  

6

Document matrix changes

i) Change of criteria for Baseline submission type from ‘Excluded: Error’ (XE) to ‘Not validated’ (NV) for specified sections.

ii) Change of criteria of 1.8.3.3 Finalised artwork-Educational/RMP materials from E to P for the submission type PV-EDU/RMP Materials.

iii) Change of criteria for 1.3 Product information.

Proposed product information for new applications should be placed in the Clean proposed section instead of the Approved section. When there are proposed changes in subsequent submissions to the Product Information, the clean amended file(s) should be submitted in the Clean Proposed section and an annotated copy of the proposals should be placed in the Annotated section.

1.

Files (2.2)

Validation severity for file types (file extensions) check amended from Warning to Error.

2

Nested Node Extension (4.5)

New validation criteria for Node Extensions.

3

File existence (4.6)

Removed 4.6.9 “No Module 3 content allowed for submission type MIV1-PI or MIV-PI-V.

4

Envelope (4.7)

Update of terminology for SG-ECTD-ID, removal of 4.7.2 UUID 4.7.4 UEN and 4.7.11d for submission withdrawal submission. Introduced 4.7.2b, check on application-number and submission-number.

5

STF (5)

New validation criteria (Error severity) for cumulative STF files.

6

Bookmarks (6.2)

Bookmarks should exist in documents with more than 10 instead of 5 pages.

7

Hyperlinks (6.3)

Validation severity for hyperlinks in response document is reduced from Warning to Information.

8

PDF properties (6.4)

The validation criteria for PDF security settings have been fine-tuned to allow electronic signatures in PDF documents. 

9

Specification document

i) 4.5.1 Specific Life Cycle Operations for Singapore: Validation severity for Table of changes (Warning instead of Error).

 ii) 4.6.3 Amendment to Table 24 Source File Requirements: Inclusion of Annotated PI and PIL.

1.

Baseline submissions 

Companies who wish to submit baseline for currently registered products in a non-eCTD format are only required to submit a Cover Letter without including Module 3 CMC data. If previously submitted and approved content are provided in a baseline submission, a declaration stating that there is no change to content currently registered with HSA as part of the Cover Letter must be provided.

2

Justifications for missing documents marked as ‘P’ 

Companies do not need to provide justifications for sections marked as ‘Possible’ (P) in the Cover Letter based on their eCTD validation results.

3

Multiple strengths, presentations and dosage forms in a single application

HSA will enable options for industry to include multiple dosage forms/presentations/strengths in a single application or submit as separate applications. Applicants should carefully weigh the pros and cons of combining or separating the strengths based on the product life cycle management of the product strengths.

4

Other administrative changes 

i) Appendix A Best Leaf Title Practices: Amendment of section numbering under 1.8.1.

 ii) Section 3.5 Transport Files: Clarification provided on transport files (XPT with extension.xpt and SAS program files with extension.sas).