Key takeaways
The HSA regularly updates its regulatory requirements and processes to ensure that they are as efficient and clear as possible. Such updates also reflect the HSA's continued collaboration efforts with key industry stakeholders, taking in the relevant feedback to further enhance its processes.
In more detail
On 28 March 2024, the HSA released four main regulatory updates for the registration of therapeutic products:
- Launch of pilot program to extend electronic labelling ("e-labelling") to pharmacy-only and General Sale List therapeutic products
E-labelling is currently implemented for prescription-only medicines in Singapore. As part of a calibrated approach in consultation with industry stakeholders, from 1 April 2024 onwards, the HSA will launch a pilot program to assess the feasibility of extending e-labelling to pharmacy-only and General Sale List therapeutic products.
- Revision of "Appendix 7: Points to Consider for Singapore Labelling" of the HSA's Guidance on Therapeutic Product Registration in Singapore
The following changes to the abovementioned guidance has come into effect from 28 March 2024. These changes include the following:
- Removal of mandatory requirement for manufacturing date to be reflected on the outer carton/inner label.
- Flexibility for either the manufacturer, product owner or registrant's name and address to be included on the outer carton/ inner label.
- Removal of mandatory requirement for precautionary statement on interchangeability of biosimilar products in the package insert.
- Minor editorial updates.
- Collaborations under Project Orbis
Project Orbis is an initiative of the US Food and Drug Administration (FDA) Oncology Center of Excellence. It provides a framework for the collaborative review of oncology products among international regulatory partners. Project Orbis is coordinated by the FDA, and it involves the regulatory authorities of the following countries: Australia, Brazil, Canada, Israel, Singapore, Switzerland and the United Kingdom. Online resources on Project Orbis are now available on the HSA website.
- Clarification on criteria for expedited review of pending minor variations (MIV) applications
The HSA has actively taken into consideration requests made by companies for expedited reviews of their MIV applications. To streamline the review process and minimise indiscriminate requests, the HSA will introduce an online request form to guide applicants on the eligibility criteria.
An expedited review request must meet one of the following criteria:
- There is no equivalent or alternative therapeutic option to the product in the Singapore market.
- The product is urgently required for supply under the National Procurement by ALPS.
- The requested change is mandatory and forms a crucial part of the National Procurement by ALPS.
While the HSA remains committed to ensuring supply continuity of therapeutic products in Singapore, companies should carefully plan their MIV submissions, taking into account the regulatory review timelines as appropriate.
Any expedited review requests should be accompanied by appropriate justifications, including the reasons for any delays in making the MIV submission. An expedited review request can be made using the online form here. The HSA will assess each request and the accompanying justifications and provide the outcome of the request via email within five working days.
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