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
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
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
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
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
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 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
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
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