Key takeaways
The HSA regularly updates its regulatory requirements and processes to ensure that they are efficient and clear for its stakeholders. Such 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.
In more detail
On 31 July 2024, the HSA released key regulatory updates for the registration of therapeutic products:
- Implementation of GMP requirements for chemical DS manufacturers
The requirement for Evidence of Good Manufacturing Practice (GMP) Compliance for manufacturers of chemical drug substances (DS) will be fully implemented on 1 October 2024.
The GMPE Requirements state that New or Generic Drug Applications (NDA or GDA) and Minor Variation Applications (MIV-1) for addition of a new DS manufacturer are to be supported by the required GMP Compliance Evidence for DS manufacturers.
The implementation of the GMPE Requirements is meant to align the requirements for both chemical and biological DS manufacturers. This forms part of the HSA's continual regulatory enhancements to assure the quality of therapeutic products supplied in Singapore. Its full implementation will enable companies to better assure the quality of therapeutic products supplied in Singapore for patients.
- New tool for estimating key evaluation milestones for NDA, GDA and MAV-1 full and abridged application
The HSA has introduced a webtool for applicants to estimate the key application milestone timelines for NDAs, GDAs and Major Variation Applications (MAV-1s). This is based off specific timepoints that the HSA has issued, e.g., applicants can expect to receive the first evaluation Input Request (IR) in:
- 160 working days for NDA/MAV-1 applications under the full evaluation route
- 120 working days for NDA/MAV-1 applications under the abridged evaluation route
- 150 working days for GDA applications under the abridged evaluation route
- New cloud-based platform for submission of application dossier and DMF "EasiShare"
Companies now have a new option of submitting their dossiers via a cloud-based file exchange software (EasiShare) in addition to the existing submission modes via electronic media (CDs/DVDs) or PRISM.
- Guidelines on post-approval changes that do not require notification to the HSA
A list of post-approval changes that do not require notification to the HSA has been published in Section 4 of Appendix 13: Guideline on MIV Applications for Chemical Therapeutic Products and Appendix 14: Guideline on MIV Applications for Biological Therapeutic Products.
For example, the notification of product labelling changes related to machine-readable codes (e.g., QR codes) for e-labelling is no longer required.
- Streamlining of risk management plan requirements for biosimilar applications
As of April 2024, the submission of risk management plan (RMP) documents, including the Singapore-Specific Annex (SSA), is no longer mandatory for biosimilar (NDA-2) applications, unless requested by HSA. The submission of RMP documents is still required for NDA-1 applications.
- Introduction of Swissmedic as HSA's reference agency
Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland, has been added as one of HSA's reference agencies, along with the European Medicines Agency (EMA), US Food and Drug Administration (FDA), Health Canada, UK Medicines and Healthcare Products Regulatory Agency (MHRA), and Australia Therapeutic Goods Administration (TGA).
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