In brief
On 1 April 2026, the Health Sciences Authority (HSA) released updates relating to the registration of therapeutic products, as part of its continued efforts to improve regulatory efficiency and enhance clarity in the regulatory requirements and processes.
Key takeaways
The HSA regularly updates its regulatory requirements and processes to ensure that they are efficient and clear for its stakeholders. These updates also reflect the HSA’s continued collaboration efforts with key industry stakeholders, taking in the relevant feedback to further enhance its processes and systems.
These updates will be relevant to those making or intending to make applications for therapeutic products in Singapore. If you require advice on the detailed requirements, please contact us.
In more detail
On 1 April 2026, the HSA announced two regulatory updates in relation to the registration of therapeutic products.
1. Electronic Common Technical Document (eCTD) format officially accepted for regulatory dossier submission
With effect from 1 April 2026, companies may submit eCTD packages for actual dossiers through the eCTD portal using SG-HSA eCTD version 1.1, which serves as the official standard for all eCTD submissions.
eCTD is the standard structured format for the electronic transfer of regulatory information related to therapeutic products from industry to health authorities. eCTD submissions minimise the need for using storage media such as CD/DVD ROMs for dossier submissions. It also allows better product life cycle management for both industry and HSA.
The technical files for defined lists, document matrix, and submission type matrix are available online for real-time access and validation, along with an updated sg-regional stylesheet.
Additionally, HSA has updated several guidance documents to include eCTD as a dossier submission option, and has also prepared several guidance resources for users to navigate the new system.
Companies are strongly encouraged to transition to eCTD, although current non-eCTD submission modes will still be accepted.
HSA will provide advance notice before any subsequent phases of the roll-out.
2. Declaration of quality defects to ensure Chemistry, Manufacturing & Controls (CMC) dossier remains valid at the point of submission
With effect from 1 June 2026, applicants are required to provide an official letter declaring that there are no currently known quality defects or critical issues that would require amendment or updates to the submitted CMC package.
This enhancement aims to promote Good Submission Practice and improve regulatory efficiency. By ensuring that the CMC dossier remains valid at the point of submission, applicants can be better supported as the inadvertent submission of superseded technical data is minimized.
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