The Therapeutic Products Branch of the Health Sciences Authority (HSA) is intending to implement electronic common technical document (eCTD) submissions in Singapore. eCTD is a standard structured format for companies to transfer regulatory information related to therapeutic products to facilitate dossier submissions.
The eCTD will be implemented in phases, and adoption by industry will be on a voluntary basis during the initial roll-out. The HSA will provide advance notice to the industry on subsequent phases.
The HSA has invited industry stakeholders to participate in the industry consultation on eCTD submissions up until 12 June 2023.
In more detail
The eCTD is the internationally recognised standard format for the electronic transfer of regulatory information to health authorities.
On 17 April 2023, the HSA issued a notice regarding the eCTD implementation to the industry. The HSA then published the eCTD specification package on 2 May. This package contains several documents, including draft eCTD specifications, validation component documents, and a Q&A document. Industry stakeholders were invited to provide comments on the eCTD specification package to facilitate the smooth implementation of eCTD in Singapore.
On 9 May 2023, the HSA held an industry briefing session on the implementation of the eCTD in Singapore where it provided an overview of the eCTD, including preparation, validation and submission through the eCTD portal.
Advantages of eCTD submissions
Introducing eCTD to enable full e-submissions minimises the need to use storage media (e.g., CD/DVD ROMs) and allows for better product life-cycle management for companies and the HSA.
The HSA has also consolidated a list of advantages of submitting regulatory information through the eCTD system instead of via the HSA’s present pharmaceutical regulatory information system (PRISM). These advantages include the following:
- eCTD submissions through the portal are entirely paperless and have the advantage of system validation that ensures 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 upload a single ZIP file.
- eCTD enables content reuse without the need to re-submit documents.
Implementation of the eCTD
The eCTD will be implemented in phases, and adoption by industry will be on a voluntary basis during the initial roll-out.
Presently, the HSA has published a Q&A document that addresses industry stakeholders’ issues regarding the eCTD, portal registration, content of eCTD submissions, document navigation, technical presentation, validation and post-marketing information.
The target implementation date for eCTD submissions in Singapore is Q4 2024. Further guidance on eCTD submissions will be published closer to the target implementation date.
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For further information and to discuss what this development might mean for you, please get in touch with your usual Baker McKenzie contact.
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