Singapore: Health Sciences Authority updated guidance

in short

In October 2024, the Health Sciences Authority (HSA) updated its guidance on evidence of implementation of good manufacturing practice (GMP) by manufacturers of drug substances (DS) (“guide“).

This is a timely revision to the guidance, as the requirement for chemical DS manufacturers to provide evidence of GMP compliance becomes mandatory from 1 October 2024, after a one-year grace period.

Effective October 1, 2024, all new or generic drug applications (NDA or GDA) and minor change applications (“IV-1“) Adding a new DS manufacturer must be supported by evidence of GMP compliance by the DS manufacturer. Applications that do not meet these requirements will not be accepted.

The guidance clarifies that this mandatory requirement does not apply to existing registered products unless a MIV-1 application is submitted to add or change drug substance manufacturers/sites.

Only GMP certificates issued by Drug Inspection Cooperation Program agencies are accepted; HSA does not accept certificates issued by third-party certification agencies.

The GMP compliance evidence requirements are intended to harmonize the requirements for chemical and biological DS manufacturers, and HSA has clarified that the GMP evidence requirements for chemical and biological DS manufacturers are similar.

HSA regularly updates its regulatory requirements and processes and provides guidance to maintain clarity for stakeholders.

You can refer to our previous updates here to learn about other initiatives taken by the HSA to enhance its processes and systems and better ensure the quality of therapeutic products delivered to patients in Singapore.

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