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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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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Pharmacy and Poisons Board of Hong Kong has issued 5 New Guidances for Advanced Therapy Products 

In June 2021, The Pharmacy and Poisons Board of Hong Kong issued 5 new guidances for Advanced Therapy Products. These guidances will be effective in August …

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HSA Singapore issues new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue

On 1st July 2021 , Health Sciences Authority (HSA) Singapore issued new guidance on Consent Requirements for Clinical Trials Involving Collection and Use of Human Tissue, which will applies …

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Access Consortium Releases Strategic Plan for 2021 – 2024

Access Consortium has released their Strategic Plan 2021-2024 in June 2021 to allow shareholders to learn more about the future …

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Singapore HSA Extends the Dossier Clarification Supplement For Biologics

HSA introduced the Dossier Clarification Supplement in April 2018 for chemical NDA and GDA to facilitate applicants to leverage the …

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