Hong Kong Drug Office Publishes Information on Requirement of Elemental Impurities Levels or Limits

Hong Kong Drug Office has published a guideline on the requirement of elemental impurities levels or limits in registered pharmaceutical products in February 2022. 

As stipulated in the International Council for Harmonisation (ICH) Q3D, if a pharmaceutical product that has been successfully registered in Hong Kong is found to contain one of the four high-risk Class 1 elemental impurities, remedial measures such as recall, or justifications will need to be provided to the authority. Class 1 elemental impurities refer to arsenic, cadmium, mercury, and lead. 

The same remedial measures will need to be taken if the product exceeds the permitted daily exposure (PDE) of the elemental impurities.  

Therefore, any applications pertaining to new chemical or biological entities (NCE) that are received on and after the 1st of January 2020 will require a submission of risk assessment by the manufacturer, as well as proof that the ICH Q3D requirements were met regarding the elemental impurities. 

More details can be found in “Requirement of Elemental Impurities Levels/Limits in Registered Pharmaceutical Products, February 2022”: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Requirement_of_Elemental_Impurities_Levels_Limits_in_Registered_Pharmaceutical_Products_EN.pdf  

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