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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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 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 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 …

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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 …

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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 …

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