A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
Beginning on October 1, 2024, drug companies submitting NDAs, GDAs, and minor variation applications in Singapore must also incorporate GMP Compliance Evidence for their drug substances. There is a grace period until September 30, 2024, but Singapore’s HSA recommends that drug substance... Read More
History and overview The Health Sciences Authority (HSA) is a government organization in Singapore that falls under the Ministry of Health. The HSA performs three primary roles: it acts as the national regulatory approval authority for all health products, manages the national... Read More
To learn more about how PBM can help you register your drug products in Singapore, please contact us. Introduction An island nation of 5.4 million people, Singapore is considered one of the most developed pharmaceutical hubs in Asia. With its current market size... Read More
In the past, API regulations in Singapore have been governed by the Poisons Act 1938 and the Medicines Act 1975. Under the Medicines Act, wholesalers and importers of APIs are recommended to apply for GMP certification, and under the Poisons Act, they... Read More
Singapore’s HSA‘s last update on GN-14 was made in 2018. Now, a new draft was announced on May 2. This document outlines and revises the risk classification of IVD medical devices in Singapore. For example, IVD medical devices that recognize the existence... Read More
Many global health authorities have already adopted eCTD drug submissions. Singapore too plans to implement this system in the fourth quarter of 2024. To ease the use of eCTD in Singapore, the HSA will broadcast an eCTD regulatory guidance over the next... Read More
By March 3, 2023, Singapore’s HSA has requested industry comments on proposed medical device labeling for cybersecurity. The draft cybersecurity labeling scheme for medical devices (CLSMD) was initiated in late 2022 by the HSA, MOH, and Integrated Health Information Systems. Today, more... Read More
PBM can help you develop the best regulatory and reimbursement strategies in Asia. Please contact us to learn more. Many drug companies doing clinical studies and product registration in Asia are now looking to add Western CDx’s to make the use of... Read More