To facilitate better traceability and follow-up actions in the event of safety or quality issues, the Health Science Authority (HSA) is launching a voluntary notification initiative for health supplements and traditional medicines. From 1 August 2022, companies may submit documents regarding their products to the HSA. If the products meet the necessary safety and quality standards and labelling requirements, they will be published on the HSA’s database, which patients and consumers can refer to when considering suitable health supplements and traditional medicines.
The Singapore Food Agency has announced that the Food Regulations 2022 will make changes to the existing Food Regulations, to allow the use of Pathogen Reduction Treatments on meat. The amendments will come into operation on 31 July 2022.
The Health Sciences Authority’s (HSA) Medical Devices Cluster (MDC) has released draft Regulatory Guidelines for Laboratory Developed Tests.
The HSA’s MDC has invited stakeholders to provide feedback on the draft document, with the consultation period being from 12 July 2022 to 12 August 2022.
In May 2022, the Singapore Personal Data Protection Commission published a guide to help organisations collect, use or disclose individuals’ biometric data in a responsible manner. With security applications like security cameras and Closed-Circuit Television Cameras becoming increasingly commonplace, there have been more cases of organisations mishandling individuals’ biometric data. The release of this guide serves as a timely reminder for organisations to review their existing measures or implement new measures to ensure that they are dealing with individuals’ biometric data in a responsible manner.
On 9 June 2022, the Health Sciences Authority issued an advisory against the purchase and use of a topical cream for diaper rash following reports of adverse effects in an infant. The product has since been found to contain a potent steroid and a synthetic medicinal ingredient.
In April 2022, the Health Sciences Authority published its revised Regulatory Guidelines for Software Medical Devices. It has also finalised its new Guidelines on Risk Classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Software, which had been released for public consultation in July to August 2021.
Given the increasing popularity of direct-to-consumer genetic testing, the Ministry of Health has taken various initiatives to raise awareness of the risks arising from the use of such tests. In addition to various social media advertisements since December 2021 and issuing an advisory for consumers in August 2021, the MOH also issued a guidance document for providers of non-clinical genetic testing in May 2021.
On 27 April 2022, the Health Sciences Authority announced that it detected potent medical ingredients in two products that were marketed on local e-commerce and social media platforms. The HSA has since removed the affected listings and issued warnings to sellers of said products.
The Therapeutic Products Branch and the Health Products Regulation Group of the Health Sciences Authority recently revised its Guidance on Therapeutic Product Registration in Singapore, which took effect on 29 April 2022.
Baker McKenzie’s Sanctions Blog published the alert titled Russia imposes blocking sanctions on foreign energy companies on 12 May 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.