Singapore: Health Sciences Authority holds industry consultation on electronic common technical document implementation

avatar
by Jacob Solomon May 29, 2023 News
Singapore: Health Sciences Authority holds industry consultation on electronic common technical document implementation

Singapore May 29 2023

It's in brief.

The Therapeutic Products Branch of the Health Sciences Authority is planning to use eCTD in Singapore.

Adoption of the eCTD will be voluntary during the initial roll-out. The industry will be given advance notice on the next phases.

Stakeholders are invited to take part in the industry consultation on eCTD submissions.

More about that.

There is a background.

The eCTD is a standard format for the transfer of regulatory information.

The eCTD implementation was brought to the attention of the industry. On 2 May, the eCTD specification package was published. The package included several documents, including a draft eCTD specifications. Stakeholders were invited to give comments on the eCTD specification package to make it easier to implement it in Singapore.

The industry was briefed on the implementation of the eCTD in Singapore by theHSA. The HSA gave an overview of the eCTD during the briefings.

There are advantages of eCTD submissions.

Allowing for better product life-cycle management is one of the benefits of introducing eCTD.

Several advantages of submitting regulatory information through the eCTD system have been consolidated by theHSA. These advantages can be used.

  • Submitting eCTD through the portal is an entirely paperless submission with the advantage of system validation to ensure successful receipt of the package by the HSA;
  • Unlike how documents are attached in PRISM, eCTD would allow companies to submit common dossiers for multiple strengths in a single application and by uploading a single ZIP file; and
  • eCTD enables content reuse without the need to re-submit documents.

The eCTD needs to be implemented.

Adoption of the eCTD will be voluntary during the initial roll-out.

The Q&A document was published to address issues that industry stakeholders have regarding the eCTD, portal registration, content of the eCTD submissions, document navigation, technical presentation, validation and post marketing information.

The implementation date for eCTD submissions in Singapore is in the fourth quarter of the century. Guidance on eCTD submissions will be published closer to the implementation date.

The content is for educational purposes only and should not be used as legal advice. This could be considered "Attorney Advertising" requiring notice in some places. Similar outcomes are not guaranteed. You can find more information at: www.bakermckenzie.com/en/client-resource-disclaimer.