Hong Kong Drug Office Updates Frequently Asked Questions’ Page
Hong Kong Drug Office has updated and included the latest set of frequently asked questions (FAQs) on their official website …
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 …
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 …
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 …
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 …
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 …
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. …
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, …
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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