Health Sciences Authority (HSA) has released the updated SG-eCTD Version 1.1 package, introducing revised specifications for electronic regulatory submissions of therapeutic products in Singapore.

The updated package provides technical documentation outlining the changes from the previous Version 1.0 and is now available for download from the HSA website. The update is part of Singapore’s ongoing efforts to strengthen regulatory infrastructure and improve the efficiency of electronic dossier submissions.

Implementation Timeline

According to the announcement from the Health Sciences Authority, the updated SG-eCTD Version 1.1 format will become the official standard for electronic Common Technical Document submissions beginning 1 April 2026.

Key transition milestones include:

• SG-eCTD Version 1.1 becomes the official submission format on 1 April 2026
  • SG-eCTD Version 1.0 will remain available temporarily during the testing phase
  • Version 1.0 will be removed after the testing period ends on 27 March 2026

Pharmaceutical companies submitting regulatory applications in Singapore after this date must ensure their submission systems comply with the updated technical package.

Impact on Regulatory Submissions

The updated SG-eCTD package includes revised technical specifications designed to improve submission validation and enhance compatibility with regulatory submission systems.

Electronic submission formats such as eCTD are widely used by regulatory authorities worldwide to standardize regulatory dossiers and streamline regulatory review processes. Updates to national specifications typically require pharmaceutical companies to review their regulatory publishing systems, validation tools, and internal submission workflows.

Regulatory affairs teams responsible for preparing electronic submissions may need to coordinate with submission software providers to ensure compatibility with the updated specifications before the implementation deadline.

Organizations managing multiple international submissions often integrate regulatory publishing processes with broader regulatory compliance and pharmacovigilance frameworks. Additional information on structured pharmacovigilance systems and regulatory safety monitoring can be found here:

https://baupharma.com/pharmacovigilance-services

Digital Regulatory Infrastructure

Singapore continues to strengthen its digital regulatory infrastructure to support efficient regulatory oversight of medicines and therapeutic products. Electronic submission platforms play an important role in enabling regulators to manage product information, evaluate applications, and maintain structured regulatory data throughout the product lifecycle.

The Health Sciences Authority has also indicated that additional digital tools are being developed to improve submission validation and provide enhanced access to regulatory technical files in the future.

These initiatives are expected to further streamline regulatory submission processes and improve communication between pharmaceutical companies and regulatory authorities.

Download the package as a zip file:  eCTD package v1.1

For more information: Update of SG-eCTD version 1.1 package