The guidance issued to address the quality and safety of cell and tissue products other than ATPs, the Department of Health adopts a whole-process approach to inform the industry and stakeholders with the current guidance. Extensive reference was made to overseas regulations, such as the relevant European Union (EU) directives and the Good Tissue Practice of the United States, in developing the guidance.
Aim of the guidance
The aim of the guidance is to provide the industry and stakeholders, including organizations involved in donor screening, testing, procurement, processing, storage, labeling, and distribution of cell and tissue products, with minimum requirements to prevent disease transmission and to ensure the quality and safety in their handling and utilization.
Stakeholders are encouraged to make reference to overseas relevant good practice guides/guidelines such as the Guide to the quality and safety of tissues and cells for human application published by the European Directorate for the Quality of Medicines & Healthcare of the Council of Europe, or the Current Good Tissue Practice published by the US Food and Drug Administration. These guides/guidelines provide specific requirements for different tissues in addition to general principles in handling human cells and tissues. Compliance with good practice guides/guidelines help to ensure the performance of staff and the quality of the products.
Stakeholders are also encouraged to seek continuous accreditation from relevant competent bodies. Accreditation involves regular evaluation and on-site inspection of compliance and is usually process or program-specific. Obtaining accreditation indicates that the industry and its organizations are dedicated to excellence in service. It is also a recognition, by competent bodies operating under a standard accreditation process, of the capability of the facility Guidance for Cell and Tissue Products 8 to perform specific activities.
Scope of the Guidance
For the purpose of the guidance, cell and tissue products refer to human cells or tissues subject to minimal manipulation and intended for homologous use. They are generally regarded as imposing lower health risk as compared to ATPs, which have been subject to substantial manipulation or are intended for non-homologous use.
Certain cells and tissues are regulated by existing legislation such as Cap. 465 the Human Organ Transplant Ordinance (HOTO) and Cap. 561 the Human Reproductive Technology Ordinance. For the cells and tissues that are regulated under the ordinances, the relevant provisions of the ordinances shall be fully complied with
For more information, please refer to
https://www.advancedtherapyinfo.gov.hk/cbb/en/doc/Guidance_for_Cell_and_Tissue_Products.pdf
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