Hong Kong Case Law: Decisions & Judgments | LexChat

Hong Kong Case Law

Good manufacturing practices (gmp)
  • 15 Oct 2020

    HKSAR v. MAK WAN LING

    Citation
    [2020] HKCFI 2679
    Court
    Court of First Instance
    Case number
    HCCC437/2015

    The 67-page GMP Guidelines for pharmaceutical products are excluded because they are not sufficiently relevant to the specific allegation that the defendant failed to ensure a properly accredited laboratory prepared the product: GMP is not accreditation, there is no evidence linking GMP compliance to accreditation for the laboratory in question, the Guidelines may not apply to cell therapy, and the defendant was not alleged to control the laboratory's internal processes; admitting the document would risk undue prejudice without probative value.