Regulatory Updates for Therapeutic Product Registration (28 Mar 2024)

As part of HSA’s ongoing initiative to improve regulatory efficiency and enhance clarity in our regulatory requirements and processes, the Therapeutic Products Branch (TPB), Health Products Regulation Group, is pleased to update industry on the following:

1. Launch of pilot programme to extend Electronic labelling (e-labelling) to pharmacy only (P) and General Sale List (GSL) therapeutic products (TP)

E-labelling is currently implemented for prescription only medicines (POM) in Singapore. Based on positive feedback received from the industry, HSA is initiating a pilot programme to assess the feasibility of extending e-labelling to non-prescription TPs (P or GSL).  

This electronic means of providing product information, including the package insert (PI) and patient information leaflet (PIL), through a machine-readable code or URL on the product carton serves to facilitate timely update of product information and enable real-time access by healthcare professionals to ensure safe and appropriate use.

As part of a calibrated approach in consultation with industry stakeholders, HSA will launch a pilot exercise with effect from 1 April 2024. Companies are encouraged to participate in the pilot for products that satisfy the eligibility criteria. For more information on the requirements and submission procedure, please refer to the Draft Guidance on e-labelling for P and GSL TPs (Apr 24).

2. Revision of Appendix 7: Points to Consider for Singapore Labelling of the Guidance on Therapeutic Product Registration in Singapore

The above guidance has been updated to include the following changes:  

i) Removal of mandatory requirement for manufacturing date to be reflected on the outer carton/inner label.

ii) Flexibility for either the manufacturer, product owner or registrant’s name and address to be included on the outer carton/ inner label.

iii) Removal of mandatory requirement for precautionary statement on interchangeability of biosimilar products in the PI.

iv) Minor editorial updates.

The updated guidance is available for download here and the changes will take effect from 28 March 2024.

3. Project Orbis webpage

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.

Online resources on Project Orbis are now available on HSA website. Industry stakeholders who are interested in participating in this initiative may access the information at Project Orbis webpage.

4. Clarification on criteria for expedited review of pending MIV applications

There have been frequent requests by companies for expedited review of MIV applications. HSA is cognizant of the importance to ensure supply continuity of therapeutic products in Singapore, hence we strongly encourage companies to plan their MIV submissions taking into account the regulatory review timelines as appropriate.  To streamline the review process and minimise indiscriminate requests, HSA will introduce an online request form to guide applicants on the eligibility criteria.

To make an expedited review request, the request must meet one of the following criteria:

i) There is no equivalent or alternative therapeutic option to the product in the Singapore market.

ii) The product is urgently required for supply under the National Procurement by ALPS.

iii) The requested change is mandatory and forms a crucial part of the National Procurement by ALPS.

Any expedited review requests should be accompanied by appropriate justifications, including the reasons for any delays in making the MIV submission. Applicants whose requests meet the above pre-requisite can submit an expedited review request using the online form (https://go.gov.sg/miv-expedited-request). We will carefully assess each request and the accompanying justifications and provide the outcome of the request via email within 5 working days.

 

 

Published: 28 Mar 2024

Regulatory Updates