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Frequently Asked Questions

  • Q.1 What are advanced therapy products?

    A.1 Advanced therapy products (ATPs) are classified as pharmaceutical products in Hong Kong. They are medicines for human use based on genes, cells or tissues. ATPs include gene therapy products, somatic cell therapy products and tissue engineered products.

    Please refer to the Pharmacy and Poisons Ordinance (Cap. 138) for the definition of “pharmaceutical product”.


  • Q.2 How are ATPs regulated in Hong Kong?

    A.2 ATP is under the definition of pharmaceutical product in the Pharmacy and Poisons Ordinance (Cap. 138). As such, regulatory requirements for pharmaceutical products under the Pharmacy and Poisons Ordinance (Cap. 138) and other relevant ordinances are applicable to ATPs, which include product registration, manufacture, labelling, sale, supply, import and export control.


  • Q.3 Do all ATPs sold in Hong Kong require registration?

    A.3 According to the Pharmacy and Poisons Regulations (Cap. 138A), ATPs should meet the safety, efficacy and quality criteria, and are registered with the Pharmacy and Poisons Board (“the Board”) before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other use in Hong Kong. Sale of unregistered pharmaceutical products is an offence under the Pharmacy and Poisons Ordinance (Cap. 138). The maximum penalty is a fine at level 6 of Criminal Procedure Ordinance (Cap. 221) ($100,000) and two years' imprisonment.

    Unregistered ATPs have not been evaluated by the Board. Their safety, efficacy and quality are not guaranteed.


  • Q.4 How do I know if an ATP is registered or not?

    A.4 The Hong Kong registration number for a registered ATP should be labelled on the sales pack in the form of “HK-XXXXX”.

    Also, the information of all registered pharmaceutical products can be found from the website of the Drug Office. By entering the pharmaceutical product’s particular(s) such as its English product name and its Hong Kong registration number, more product information can be obtained through the “Search Drug Database” at http://www.drugoffice.gov.hk/eps/do/en/consumer/search_drug_database.html. If the pharmaceutical product is an ATP, a remark indicating the product is an ATP will be displayed on the search result.


  • Q.5 Are all ATPs safe and effective?

    A.5 According to international standards, a new medicine should first be tested in the laboratory and in animal studies before they can be used in clinical trials for human. When the medicine is proved to be safe and effective, it can be put to general uses. Any ATP which fails in any phase of a clinical trial would be regarded as “unproven”, which means that its safety and efficacy has not been established. An unproven ATP may pose serious, or potentially fatal, risks to your health including infection, allergic reactions, rejection of the cells by your immune system and development of cancer.

    At the same time, the quality of ATPs can affect the safety and efficacy of the products. Therefore, ATPs should be manufactured by qualified manufacturers to ensure that the products can meet the required quality standard.


  • Q.6 How can I acquire an ATP? Where can I receive the ATP treatment?

    A.6 In general, ATPs are prescription only medicines which should be supplied by registered doctors or registered dentists.

    In addition, pursuant to the Private Healthcare Facilities Ordinance (Cap. 633) (PHFO), procedures involving the transplant of cell- or tissue-containing ATPs to patients (including autologous transplant) are Scheduled Medical Procedures specified under the PHFO. If such procedure is performed in private healthcare facilities, it should only be performed in hospitals or day procedure centres for which a relevant licence under the PHFO is in force. For further details, please refer to the website of the Office for Regulation of Private Healthcare Facilities, Department of Health (www.orphf.gov.hk). For the definition of Scheduled Medical Procedures, please refer to section 2 of and Schedule 3 to the PHFO (www.elegislation.gov.hk/hk/cap633).


  • Q.7 Is transplant of cells or tissues regarded as ATPs?

    A.7 High-risk cell and tissue products, e.g. cells and tissues that have been subjected to substantial manipulation or have their functions changed, are regarded as ATPs. However, certain procedures involving cells or tissues which are widely used in medical field, e.g. blood transfusion, bone marrow and cornea transplant, are not regarded as ATPs.


  • Q.8 What is immune cell therapy?

    A.8 The immune cells, which include natural killer cells (NK cells), dendritic cells (DCs), cytokine-induced killer cells (CIK cells) and T cells, are part of our immune system. These cells are usually subject to substantial manipulation in order to be used for medical purpose and if so, are regarded as ATPs.

    You may visit the website below for information on cell therapy: https://www.advancedtherapyinfo.gov.hk/


  • Q.9 What is stem cell therapy?

    A.9 Stem cells are primitive cells that have yet grown into specialized cells. Examples include stem cells derived from cord blood, adipose tissue and sheep amniotic membrane. When a treatment uses stem cells, or cells derived from stem cells, to replace or repair a patient’s damaged tissues or cells such treatment is known as stem cell therapy.

    Stem cell therapy for medical use in humans is generally regarded as ATP. Currently, there is no registered ATP containing stem cells in Hong Kong. Please note that the safety, efficacy and quality of unregistered ATPs are not guaranteed.

    You may visit the website below for information on stem cell therapy: https://www.advancedtherapyinfo.gov.hk/


  • Q.10 What is cord blood?

    A.10 Cord blood is the blood that can be drawn from the umbilical cord of a baby after birth. Cord blood is a rich source of haematopoietic (blood-forming) stem cells, which may be used to treat a variety of blood diseases. While certain blood diseases such as leukaemia may use haematopoietic stem cells for treatment, uses on other diseases are still under clinical trials and their benefits are yet to be proven.

    If the cord blood or its derived product falls within the definition of ATP under the Pharmacy and Poisons Ordinance (Cap. 138), it will be regulated as pharmaceutical product as mentioned in A2.

    Please note that cord blood is usually preserved in cord blood banks by freezing technique for use after a substantial period of time. At present, certain international accreditation bodies provide audit and accreditation services for cord blood banks.

    You may visit the website below for information on cord blood banking: https://www.advancedtherapyinfo.gov.hk/


  • Q.11 What should I be cautious about if I am considering an ATP treatment?

    A.11 Before you receive an ATP treatment, you should be cautious about:

    • Is the ATP registered in Hong Kong? Or is the product authorized for use overseas?
    • Is the ATP manufactured by a qualified manufacturer?
    • Where will I receive the ATP treatment?
    • Who will be responsible for carrying out the ATP treatment?
    • Are there any risks after receiving the ATP treatment?
    • Is there any appropriate long-term follow-up, and how?

  • Q.12 If I have other questions about the regulation of pharmaceutical products in general, what can I do?

    A.12 Should you have questions about the regulation of pharmaceutical products, please refer to FAQs for pharmaceutical products in general.


  • 1 August 2021

 
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