Singapore Drug Registration: 2024 Update

In late March, Singapore’s HSA promulgated a number of updates for the registration of drugs. First, from April 2024, the HSA will look at a pilot program to use e-labeling for pharmacy-only and generally listed therapeutic products – in addition to RX products that currently use e-labeling. Second, the HSA has tried to clarify the requirements for expedited review of minor variations for drugs. Soon, the HSA will initiate an online form to help direct applicants on the eligibility of this new minor variation program. To be considered for an expedited review, the drug must meet certain criteria: there should be no alternative medicine available in Singapore, it should be required for National procurement, and there must be an urgent need for it, among other considerations. To request an expedited review for a minor variation the applicant must submit related documentation. The HSA will review the materials provided and determine within 5 days whether the request is justified.

Third, the HSA made some changes to Appendix 7 for therapeutic drug registration in Singapore. The requirement for indicating the date of manufacture on the outer packaging or inside label, as well as the warning statement concerning alternative uses of biosimilar products on the package label, has been removed. There is now more flexibility regarding the inclusion of the product owner’s name, drug manufacturer’s name, or registrant’s name and address on the outer drug carton or package insert. Additionally, there have been a few other less significant changes. Finally, online information on the HSA site for Project Orbis will now be available. Project Orbis is the US FDA’s program that includes a number of global regulatory bodies (including Singapore) working together on cancer projects.