HSA Singapore Introduces an Online Self-Guided Tool for Post-approval Minor Variation Applications
HSA Singapore has launched on 20 August 2021 a new online self-guided tool for post-approval minor variation applications (MIV) to help industry stakeholders …
Hong Kong Drug Office Publishes Guidance Note on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity
Hong Kong Drug Office has published a guidance note on the registration of pharmaceutical products containing a new chemical or …
Singapore HSA Published Finalised Guidance on the Medical Device Unique Device Identification (UDI) System
Singapore HSA has published the finalised Guidance on the Medical Device Unique Device Identification (UDI) System on 27 August 2021. This guidance document …
Singapore HSA and Malaysia NPRA Launch the HSA-NPRA Generic Medicines Work Sharing Initiative
The Health Sciences Authority (HSA) Singapore and the National Pharmaceutical Regulatory Agency (NPRA) Malaysia have launched the HSA-NPRA Generic Medicines Work …
Australia TGA Publishes Finalised Guidance Document on Regulatory Changes for Software Based Medical Devices
Therapeutic Goods Administration (TGA) Australia has published the finalised guidance document on regulatory changes for software-based medical devices in August 2021. The guidance provides a …
Philippines FDA Issues Circular on Guidelines for the Transition Period for Medical Device to the ASEAN Harmonized Technical Requirements
This Circular issued on 9 August 2021 aims to provide guidelines for the transition period of medical devices covered by FC No. …
Australia TGA Publishes Updated Document on Prescription Medicines Registration Process
Therapeutic Goods Administration (TGA) Australia published an updated document on the registration process for prescription medicine applications on the 12th of August …
NPRA Malaysia Issues Updated Guidance Document on Conditional Registration of Pharmaceutical Products During Disaster
National Pharmaceutical Regulatory Agency (NPRA) Malaysia issued an updated guidance document on the requirements of Conditional Registration of Pharmaceutical Products during Disaster, in July 2021. The main …
Hong Kong Drug Office Updates Guidance for Adverse Drug Reaction Reporting Requirements to Add Considerations for Advanced Therapy Products
Hong Kong Drug Office updated Guidance for Adverse Drug Reaction Reporting Requirements to include special considerations for advanced therapy products in section 6, to …