Chinese Medicine Regulatory Office

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What's New

What's New

  • The coming GMP sharing session will be held on 24 April 2024 via Zoom, a letter informing proprietary Chinese medicines manufacturers of relevant details has been issued. Should traders wish to attend the sharing session, please complete the reply slip for registration and return to the Chinese Medicine Regulatory Office by fax or email before 22 April 2024.

    • Date： 24 April 2024 (Wednesday)
    • Time： 3:00pm - 4:15pm
    • Topic：Preparation for Proprietary Chinese Medicine GMP Certificate Application (Language: Cantonese)
    In addition, the relevant information of previous GMP sharing sessions could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Supplier Qualification and Management” and “e-Service” was successfully held on 8 Mar 2024. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Brief on Cleaning Validation and Deficiency Analysis” and “e-Service” was successfully held on 11 Dec 2023. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Safety Management in pCm Manufacturing and QC Laboratory” and “e-Service” was successfully held on 27 Oct 2023. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Qualification of Stability Chamber” and “e-Service” was successfully held on 18 Aug 2023. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Common deficiencies found during Hong Kong pCm GMP inspections and their review (2021-2023)”,“GMP inspections focus in 2023-2025” and “e-Service” was successfully held on 12 May 2023. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Monitoring of Cleanroom Environment and Purified Water Quality” and “e-Service” was successfully held on 3 Mar 2023. The relevant information could be downloaded from from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Quality risk management” and “e-Service” was successfully held on 29 Dec 2022. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Materials Management and Temperature Mapping Study” and “e-Service” was successfully held on 28 Oct 2022. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Data Integrity and Security” was successfully held on 7 Jun 2022. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Quality Management in Microbiology Laboratories (3)” was successfully held on 28 Apr 2022. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Quality Management in Microbiology Laboratories (2)” was successfully held on 1 Apr 2022. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Quality Management in Microbiology Laboratories (1)” was successfully held on 17 Dec 2021. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “GMP inspection deficiency: Document control” was successfully held on 22 Oct 2021. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “GMP inspection deficiency: Document control” was successfully held on 16 Jul 2021. The relevant information could be downloaded from the "GMP Sharing Sessions" on this Web Resources Platform.
  • The online GMP Sharing Session on “Common deficiencies found during Hong Kong pCm GMP inspections and their review (2019-2021)” and “GMP inspections focus in 2021-2023” was successfully held on 27 May 2021. The relevant information could be downloaded from the "GMP Sharing Sessions" on this Web Resources Platform.
  • The coming GMP sharing sessions will be held on 27 May 2021 via Zoom, a letter informing proprietary Chinese medicines manufacturers of relevant details has been issued. Should traders wish to attend the sharing session, please complete the reply slip for registration and return to the Chinses Medicine Regulatory Office by fax or email before 24 May 2021.

    Date:27 May 2021 (Thursday)
    Time:3:00pm - 4:15pm
    Topics: i) Common deficiencies found during Hong Kong pCm GMP inspections and their review (2019-2021)
    ii) GMP inspections focus in 2021-2023 (Language: Cantonese)

    In addition, the relevant information of previous GMP sharing sessions could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.
  • The online GMP Sharing Session on “Qualification of Manufacturing Equipment” was successfully held on 26 Feb 2021. The relevant information could be downloaded from the "GMP Sharing Sessions" on this Web Resources Platform.
  • The online GMP Sharing Session on “Concerns relating to Purified Water System from GMP inspection findings” was successfully held on 18 Dec 2020. The relevant information could be downloaded from the "GMP Sharing Sessions" on this Web Resources Platform.
  • The GMP Sharing Session scheduled in October 2020 has been cancelled. The relevant information has been uploaded to the "GMP Sharing Sessions" for downloading and reference. (20 October 2020)
  • The GMP Sharing Session scheduled in July 2020 has been cancelled. The relevant information has been uploaded to the "GMP Sharing Sessions" for downloading and reference. (24 July 2020)
  • The GMP Sharing Session scheduled in April 2020 has been cancelled. The relevant information has been uploaded to the "GMP Sharing Sessions" for downloading and reference. (8 April 2020)
  • The GMP Sharing Session on “Common deficiencies found during Hong Kong pCm GMP inspections and their review” and “Management and disposal of chemical reagents of quality control laboratory” was successfully held on 17 Jan 2020. The relevant information could be downloaded from the “GMP Sharing Sessions” on this Web Resources Platform.