Singapore HSA Signs Memorandum Of Understanding With Hong Kong DoH To Enhance Healthcare Regulatory Cooperation
Singapore’s Health Sciences Authority (HSA) and the Department of Health (DoH), Hong Kong Special Administrative Region (HKSAR) signed a Memorandum …
Singapore HSA Updates Therapeutic Product Registration Guidelines
As part of Singapore’s Health Sciences Authority (HSA) ongoing initiative to improve regulatory efficiency and enhance clarity in Therapeutic Products’ …
Singapore HSA Updates Guidelines on Risk Classification of SaMD and Qualification of CDSS
Singapore HSA Medical Devices Cluster has updated Guidelines on Risk Classification of Software as a Medical Device (SaMD) and Qualification …
Singapore HSA Revises FSCA Related Guidances for Medical Device GN-09 and GN-10
Singapore Health Sciences Authority (HSA) revises guidance documents related to Medical Device Field Safety Corrective Action (FSCA). Detail of the …
Singapore HSA Updates Medical Device Guidance on Change Notification
Singapore HSA has updated GN-21: Guidance on Change Notification for Registered Medical Devices, effective 14th July 2025. Key Updates to …
Malaysia NPRA Publishes Screening Package for New Drug Products and Biologics
To enhance the submission process, Malaysia NPRA has developed a screening package for New Drug Products and Biologics to provide …
Vietnam Ministry of Health Issues Circular on Registration of Drugs and Medicinal Ingredients for Circulation in Vietnam
On May 16, 2025, Vietnam Ministry of Health issued the Circular No. 12/2025/TT-BYT which will take effect from July 1, …
Malaysia Medical Device Authority (MDA) announces two key changes to the Product Classification Letter process.
1. Fully Online Application Process In line with its digital transformation efforts, MDA will fully transition to online submissions for …
FDA Philippines Issues Advisory on Streamlined Submission of Multiple Post-Approval Changes (PACs)
The Food and Drug Administration (FDA) Philippines released FDA Advisory No. 2025-0496 on 10 April 2025, titled “Allowing the Submission …
More News
#pharmaceuticalindustry
#regulatoryaffairs
ASEAN
Australia
Biologics/Biosimilars
Canada
China
Clinical Trials
Cosmetics
CTGTP
eCTD
EU
Global
Health Supplements
Herbal/Traditional Medicines
Hong Kong
India
Indonesia
Japan
Malaysia
Medical Devices
New Zealand
Pharmaceutical Drugs
Philippines
regulatory
regulatoy
Singapore
South Korea
Sri Lanka
Switzerland
Taiwan
Thailand
United Kingdom
United States
Vietnam