With effect from 1 September 2021, applicants are required to submit the HSA’s acknowledgement email on the receipt of the Letter of Access from the DMF holder as documentary proof
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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 to get quick answers on the application type, variation category
read more...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 biological entity (NCE) in August 2021.
The aim of the document is to
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 is intended to provide clarity on the regulatory requirements for Unique
read more...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 Sharing Initiative in August 2021.
This initiative is a work sharing model for the
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 summary of changes to the regulation of software-based medical devices (including
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. 2021-002 may apply for Certificate of Medical Device Notification (CMDN) for the manufacture,
read more...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 2021.
The scope of the document is for applications that need
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 objective of this guidance document is to provide expedited access to pharmaceutical
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