Analytical & Advisory Services Division

Chinese Medicines Section

About the Section

This Section was established on 7th October 1998. Its major responsibilities are to provide testing services and technical support for the safety monitoring of proprietary Chinese medicines and Chinese herbal medicines sold on the market, and to conduct development work on analytical methodology.

Proprietary Chinese Medicines

Proprietary Chinese Medicines

Chinese Herbal Medicines

Chinese Herbal Medicines

Responsibilities

This Section helps to implement the following legislations:

  • Chinese Medicine Ordinance (Cap. 549)
  • Import and Export Ordinance (Cap. 60)

This Section examines Proprietary Chinese medicines and Chinese herbal medicines submitted mainly by the Department of Health (DH).

Proprietary Chinese medicines and Chinese herbal medicines are analyzed for their safety and quality, including the determination of pesticide residues, sulphur dioxide residues, aflatoxins and heavy metals/toxic elements. Urgent analytical services are also provided to DH for investigations into suspected poisoning cases and reports of adverse drug reactions related to the consumption of Chinese medicines. Besides, chemical marker identification testing is conducted for suspected unregistered proprietary Chinese medicines.

Quality Assurance

About 10% of the tests conducted in the Section are for QC purposes.

Key Instruments

The following instruments are used routinely by the Section:

  • Gas Chromatograph with Electron Capture Detector, Flame Photometric Detector, Thermal Conductivity Detector and Mass Selective Detector
  • UV/VIS Spectrophotometer
  • Automatic Gel Permeation Chromatograph
  • Fourier Transform Infrared Spectrophotometer
  • High Performance Liquid Chromatograph - Tandem Mass Spectrometer
  • Inductively Coupled Plasma - Mass Spectrometer
  • Gas Chromatograph - Tandem Mass Spectrometer
  • High Performance Liquid Chromatograph - Quadrupole - Linear Ion Trap - Orbitrap Tribrid Mass Spectrometer
High Performance Liquid Chromatograph - Tandem Mass Spectrometer

High Performance Liquid Chromatograph - Tandem Mass Spectrometer

High Performance Liquid Chromatograph - Quadrupole - Linear Ion Trap - Orbitrap Mass Spectrometer

High Performance Liquid Chromatograph - Quadrupole - Linear Ion Trap - Orbitrap Tribrid Mass Spectrometer

Targets and Key Indicators

Key Performance Measures Relating to the Statutory Testing of Chinese Medicines

Targets #
Targets 2023 (Actual) 2024 (Actual) 2025 (Plan)
95 100 100 95

Targets 2023 (Actual) 2024 (Actual) 2025 (Plan)
95 99 99 95

# For targets where reporting time is mentioned, different samples require different analytical procedures, hence different reporting time. The quoted number of working days required represents an average of reporting time for the different types of samples and test requests within the category, while the target (in percentage) is the total compliance rate of the concerned samples and test requests within a particular category against their respective targets.

Key Indicators
Tests Performed on Chinese Medicines 2023 (Actual) 2024 (Actual) 2025 (Estimate)
Urgent samples relating to Chinese
medicine incidents
30 4 N.A.
Other Chinese medicine samples 86,133 87,876 86,000

‡ As the testing requirements for urgent samples relating to food, pharmaceuticals and Chinese medicine incidents respectively fluctuated in previous years, it is difficult to estimate the occurrence of the type of incidents or the number of tests required.