POST-INDUSTRY CONSULTATION UPDATES ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE

No.

Issue

Solution

1.

Need for companies to generate UUID and construct application folder name using PRISM application number which is prone to error

HSA will issue a unique e-identifier via the portal to be used as the application folder name.

Companies no longer need to generate UUID.

2.

Lack of clarity on the submission procedures:

a)Need for companies to use PRISM for application filing and eCTD portal for transmitting the dossier

b)Requirements for baseline submissions

HSA will update the specification document to clarify the order of submission in PRISM and eCTD portal.

HSA will include illustrations of business workflow for baseline and transfer submissions.

3.

Need for guidance on the procedures for submitting multiple dosage forms/presentations in one eCTD application

HSA will enable options for industry to include multiple dosage forms/presentations/strengths in a single application or submit as separate applications.

Guidance for industry on the submission procedures and module organisation to enable a single application will be provided in the updated package.

4.

Lack of SG regional stylesheet to facilitate viewing of envelope information

HSA will include a regional stylesheet in the specification components package.

5.

Electronic signatures on PDF documents are not allowed due to the security settings specified in validation criteria

HSA will fine-tune the validation criteria to allow electronic signatures in PDF documents.