Therapeutic Goods Administration (TGA) Australia has published a document regarding its business plan and the priorities for 2021 and 2022.
The business plan contains detailed information on the priorities, which are product regulation and safety,
Regulatory News
Philippines FDA Issues Circular on the Reference List of Class A Medical Devices
The Philippines Food and Drug Administration (FDA) has issued Circular No. 2021-017 on the 16th of August 2021, to guide manufacturers, importers, distributors, and other stakeholders in the medical device industry regarding the list of medical devices classified as Class A. The circular will
read more...NPRA Malaysia Issues Updated Guidance Document on Foreign GMP Inspection
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued an updated guidance document on foreign GMP inspection in August 2021.
The main update is regarding the “GMP Distant Assessment (DiA)” for foreign production facilities, which is effective from
read more...Australia TGA Publishes Document on Refinements to the Personalised Medical Device Framework
Therapeutic Goods Administration (TGA) Australia has published a document regarding the refinements to the personalised medical device framework in August 2021.
After a public consultation regarding proposed refinements in July 2021, the refinements that have been included are
NPRA Malaysia Issues Updated Guidelines for Pharmacovigilance
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued two updated guidelines for pharmacovigilance in August 2021.
The updated guidelines are:
“Malaysian Guidelines on Good Pharmacovigilance Practices (GVP) for Product Registration Holders, First Edition, August 2021” (effective
read more...HSA Singapore Revises Drug Master File Submission Process in GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION
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
read more...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...