In more detail
With effect from 1 October 2024, all new or generic drug applications (NDA or GDA) and minor variation applications ("MIV-1") for adding a new DS manufacturer must be supported by GMP compliance evidence for DS manufacturers. Applications that fail to meet these requirements will not be accepted.
The Guidance clarifies that this mandatory requirement does not apply to existing registered products, except when an MIV-1 application is submitted for addition or replacement of manufacturer/site of drug substance.
Only GMP certificates issued by a Pharmaceutical Inspection Co-operation Scheme authority will be accepted; the HSA will not accept certificates issued by third-party certification schemes.
The requirement for evidence of GMP compliance is intended to align the requirements for both chemical and biological DS manufacturers, and the HSA has clarified that the GMP evidence requirements for chemical and biologic DS manufacturers are similar.
Key takeaways
The HSA regularly updates and provides guidance on its regulatory requirements and processes to maintain clarity for its stakeholders.
You may refer to our previous update here for other initiatives made by the HSA to enhance its processes and systems and better assure the quality of therapeutic products supplied in Singapore for patients.
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