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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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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Hong Kong DOH Updates List of Recognised Standards for Medical Devices

In May 2021, Hong Kong Department of Health updated the RS-01: List of Recognised Standards for Medical Devices  Medical devices …

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Hong Kong DOH Updates Guidances for Listing of General Medical Devices and IVDs

In April 2021, Hong Kong Department of Health updated the guidances for listing of Class II/III/IV General Medical Devices and Class B, C and D In Vitro Diagnostic …

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Hong Kong DOH Revised Submission Timeframes for Medical Device Adverse Event Reports

In April 2021, Hong Kong Department of Health updated the GN-03, Guidance Notes for Adverse Event Reporting by Local Responsible Persons.  …

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Hong Kong Department of Health (DoH) to Enhance Regulatory Control of Skin Antiseptic Products

To safeguard public health in the safe and proper use of all skin antiseptic products containing substances other than chlorhexidine, …

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Hong Kong DoH has updated the Guidance Notes for Overview of the Medical Device Administrative Control System

On 4 November 2020, the Hong Kong Department of Health has issued a new version of Guidance Notes: GN-01 Overview …

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Hong Kong Issues New Guidance for Cell and Tissue Products

The guidance issued to address the quality and safety of cell and tissue products other than ATPs, the Department of …

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