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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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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 …

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