General Information
Classification of ATPs
Registration of ATPs
Clinical Trial of ATPs
Import/Export of ATPs
Licensing
Others
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General Information |
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Q.1 What is “advanced therapy product” (ATP)?
A.1 ATPs are pharmaceutical products for human use based on genes, cells or tissues. According to Section 2 of the Pharmacy and Poisons Ordinance (Cap. 138), pharmaceutical product–
(a) means a substance or combination of substances that —
(i) is presented as having properties for treating or preventing disease in human beings or animals; or
(ii) may be used in or administered to human beings or animals with a view to —
(A) restoring, correcting or modifying physiological functions by exerting a pharmacological,
immunological or metabolic action; or
(B) making a medical diagnosis; and
(b) includes an ATP.
ATP means any of the following products that is for human use–
(a) a gene therapy product;
(b) a somatic cell therapy product;
(c) a tissue engineered product.
The relevant definitions of gene therapy product, somatic cell therapy product and tissue engineered product are stipulated in Section 2 of the Pharmacy and Poisons Ordinance (Cap. 138).
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Q.2 What Ordinances in Hong Kong are (or may be) relevant to ATPs?
A.2 The following Laws of Hong Kong may provide regulation to ATPs:
- Pharmacy and Poisons Ordinance (Cap. 138)
- Import and Export Ordinance (Cap. 60)
- Prevention and Control of Disease Regulation (Cap. 599A)
- Undesirable Medical Advertisements Ordinance (Cap. 231)
- Trade Descriptions Ordinance (Cap. 362)
- Human Organ Transplant Ordinance (Cap. 465)
- Human Reproductive Technology Ordinance (Cap. 561)
Pharmacy and Poisons Ordinance (Cap. 138)
As stated in A1, ATP falls within the definition of pharmaceutical product. Under the Pharmacy and Poisons Ordinance (Cap. 138), an ATP must be registered with the Pharmacy and Poisons Board before it can be supplied in Hong Kong. Registered ATP should be labelled with the Hong Kong registration number, in the form of "HK-XXXXX", on its container. Suppliers and manufacturers of ATPs must also apply for relevant licences, i.e. Wholesale Dealer Licence and Licence for Manufacturer of Pharmaceutical Products respectively. Currently, all licensed manufacturers of pharmaceutical products must fully comply with the Good Manufacturing Practice (GMP) of the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
In addition, according to Regulation 36B of the Pharmacy and Poisons Regulations (Cap. 138A), a person must not conduct a clinical trial on human beings, or cause or permit such a trial to be conducted except in accordance with a clinical trial certificate issued to the person.
Moreover, the Pharmacy and Poisons Regulations (Cap. 138A) stipulates the labelling and record keeping requirements specific to ATPs in order to enhance their traceability.
Import and Export Ordinance (Cap. 60)
The import and export of ATPs are regulated under the Import and Export Ordinance, which provides that all importation and exportation of an ATP into or out of Hong Kong must be under the authority of a valid licence.
Prevention and Control of Disease Regulation (Cap. 599A)
If a person imports biological material into Hong Kong and he / she has reason to suspect that the material contains an infectious agent, he / she shall obtain a permit from the Director of Health. Application details for import of biological materials are available at
https://www.dh.gov.hk/english/useful/useful_forms/useful_forms_qpd.html.
Undesirable Medical Advertisements Ordinance (Cap. 231)
The Undesirable Medical Advertisements Ordinance prohibits advertisements of medicine, surgical appliance or treatment to claim curative or preventive effects on any diseases or conditions in human beings as specified in the Schedules to the Ordinance.
Trade Descriptions Ordinance (Cap. 362)
The Trade Descriptions Ordinance aims at protecting consumers by prohibiting the application of false trade descriptions to goods or services in the course of trade or operation of business and the supply or offering to supply any goods or services to which false trade description is applied. It also prohibits specified unfair trade practices, including misleading omissions, aggressive commercial practices, bait advertising, bait-and-switch and wrongly accepting payment, deployed by traders against consumers.
Human Organ Transplant Ordinance (Cap. 465)
The Human Organ Transplant Ordinance prohibits commercial dealings in human organs intended for transplanting, and restricts the transplanting of human organs between living persons and the transplanting of imported human organs. A person is guilty of an offence if he makes or receives any payment for the supply of, or for an offer to supply an organ which is removed from a dead or living person and is intended to be transplanted into another person. More information on the regulation of human organ transplant in Hong Kong is available at the webpage of the Department of Health (http://www.dh.gov.hk/english/links/links_hot.html).
Human Reproductive Technology Ordinance (Cap. 561)
The Human Reproductive Technology Ordinance is to regulate reproductive technology procedures, and the use, for research and other purposes, of embryos and gametes. It also confines the provision of reproductive technology procedures to infertile couples subject to any express provision to the contrary in any code.
The above list of Ordinance and Regulation is not exhaustive and traders should seek legal advice on the legality of their business. For the contents of the relevant legislation, please refer to the website of Hong Kong e-Legislation at https://www.elegislation.gov.hk.
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Classification of ATPs |
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Q.3 How do I know whether my product is an ATP?
A.3 As stated in A1, the Pharmacy and Poisons Ordinance (Cap. 138) stipulates the definition of ATP. If your product falls within the definition of ATP, it will be classified as ATP (and thus a pharmaceutical product) and subject to the regulatory control under the relevant ordinances.
In determining whether a product falls within the definition of ATP, you should thoroughly assess all the available product information which includes:
(a) the active ingredient of the product;
(b) the preparation process of the active ingredient of the product;
(c) the use and mode of action of the product; and
(d) the presentation of the product.
All the information should be taken into account as a whole in the classification assessment. For further details, please refer to “Guidance on Classification of Advanced Therapy Products” issued by the Pharmacy and Poisons Board, available at https://www.ppbhk.org.hk/eng/regulation_of_atp.html.
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Q.4 Are products containing cells and tissues from animal source included for consideration as ATPs?
A.4 Yes. A product containing or consisting of cells or tissues from human and/or animal origin that falls within the definition of ATP will be considered as an ATP.
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Q.5 If a skincare product containing stem cell serum with extract peptides, will it be considered as an ATP?
A.5 If a skincare product only contains peptides extracted from stem cells and does not contain or consist of any viable cells or tissues, it generally does not fall within the definition of ATP. However, please note that a product does not fall within the definition of ATP may still fall within the definition of pharmaceutical product (e.g. the product is intended for treatment of skin disease). For details regarding the classification of pharmaceutical product, please refer to the “Guidance Notes on Classification of Products as ‘Pharmaceutical Products’” under the Pharmacy and Poisons Ordinance (Cap. 138)” available at
https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guide_on_PRClass.pdf.
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Q.6 Are cord blood cells from cord blood banks considered as ATPs?
A.6 If a product containing cord blood cells derived from cord blood falls within the definition of ATP, the product must be registered with the Pharmacy and Poisons Board before it can be supplied in Hong Kong. You can refer to A3 regarding classification of ATP.
In addition, you can visit https://www.advancedtherapyinfo.gov.hk for more information on cord blood banking.
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Q.7 Are bone or tissue grafting products that are derived from human or animal origin and are intended for regenerating a human tissue considered as ATPs?
A.7
If a bone grafting product (e.g. bone graft, bone powder and bone paste) or tissue grafting product (e.g. membrane derived from pericardium or dermis) contains or consists of exclusively non-viable human or animal cells or tissues and does not act principally by pharmacological, immunological or metabolic action (e.g. providing structural support or physical barrier), it generally does not fall within the definition of ATP.
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Registration of ATPs |
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Q.8 Are ATPs sold in Hong Kong registered?
A.8
As stated in A2, the regulatory requirements for pharmaceutical products apply to ATPs. As stipulated under Regulation 36(1) of the Pharmacy and Poisons Regulations (Cap. 138A), pharmaceutical products must be registered before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other uses in Hong Kong.
The Hong Kong registration number for a registered ATP should be labelled on the container in the form of "HK-XXXXX”. Information on registered ATPs are available on the website of the Drug Office as follows:
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 year’s imprisonment.
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Q.9 How can I apply for registration of an ATP and what documents are required?
A.9
You should submit your new application via the online Pharmaceutical Registration System 2.0 (PRS 2.0) at https://www.drugoffice.gov.hk/prs2-ext/client_authentication.jsp together with the application fee. If the ATP is manufactured in Hong Kong, the person responsible for obtaining registration of the ATP should be the licensed manufacturer, or the licensed wholesale dealer contracting with the licensed manufacturer. If the ATP is manufactured outside Hong Kong, the person responsible for obtaining registration should be the licensed wholesale dealer importing the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas of the manufacturer.
When an application is approved, the applicant will receive the Certificate of Drug / Product Registration upon payment of the fee.
An ATP will only be approved for registration if it meets the criteria of safety, efficacy and quality relevant to it. For the documents required, please refer to the “Guidance on Application of Certificate of Drug/ Product Registration – Advanced Therapy Products” issued by the Pharmacy and Poisons Board, available at https://www.ppbhk.org.hk/eng/regulation_of_atp.html.
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Q.10 What are the labelling requirements of ATPs for the purpose of registration?
A.10 The labelling requirements of pharmaceutical products are applicable to ATPs. In addition, ATPs should be labelled with ‘product code’ and ‘unique donation identifier’. For ATPs for autologous use, ‘unique recipient identifier’ and the English words “For autologous use only” or the Chinese characters “只供自体使用” should also be labelled.
For details, please refer to the Pharmacy and Poisons Ordinance (Cap.138) and the following guidance documents:
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Q.11 What medical claims can I put on the labels of ATPs?
A.11
Claims should be substantiated by reputable references or data from clinical trials. In addition, you should observe the provisions of the relevant Ordinances such as the Undesirable Medical Advertisements Ordinance (Cap. 231) and the Trade Descriptions Ordinance (Cap. 362) as mentioned in A2.
For the Undesirable Medical Advertisements Ordinance (Cap. 231), you may also refer to the “Guidelines on the Undesirable Medical Advertisements Ordinance, Cap. 231”available at the webpage of our office (https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guidelines_Notes_on_the_UMAO.pdf).
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Clinical Trial of ATPs |
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Q.12 What should I do if I want to conduct a clinical trial of ATP in Hong Kong?
A.12
You need to apply for a clinical trial certificate in order to conduct any clinical trial on human beings in Hong Kong. The applicant could be—
- sponsor of the clinical trial or a local company that holds relevant licence(s) (e.g. wholesale dealer licence) and that can handle ATPs
- sponsor-investigator who initiates and conducts a clinical trial
- principal investigator who conducts the clinical trial
For details about the application, please refer to the “Guidance on Application of Certificate for Clinical Trial – Advanced Therapy Products” issued by the Pharmacy and Poisons Board, available at https://www.ppbhk.org.hk/eng/regulation_of_atp.html.
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Q.13 What documents are required for the application for the clinical trial certificate of an ATP?
A.13 To apply for a clinical trial certificate of an ATP, you should submit the completed application form, checklist and the relevant documents as specified in the “Guidance on Application of Certificate for Clinical Trial – Advanced Therapy Products” (as mentioned in A12). Due to the complicated nature of ATPs, you should take note of the requirements on traceability, risk minimisation measures, long-term follow-up, etc. relevant to ATPs when devising the proposed protocol, investigator’s brochure and patient consent form. Please refer to Appendix 3 of the guidance document for further details.
The application for clinical trial certificate should be submitted to the Drug Evaluation and Import/Export Control Division of our office by email (ct@dh.gov.hk) or mail (Suites 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon).
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Import/Export of ATPs |
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Q.14 What is the procedure of importing or exporting an ATP?
A.14
You need to hold an appropriate trader licence for handling ATP (e.g. Wholesale Dealer Licence). Then, for every single importation or exportation, you need to apply for an Import Licence or Export Licence from Drug Evaluation and Import/Export Control Division of Department of Health. For details, please refer to the “Guidance on Application of Import and Export Licences – Advanced Therapy Products” available at https://www.drugoffice.gov.hk/eps/do/en/doc/atp_guidance/DO_Guidance_IE_ATP-EN.pdf.
Due to the nature of ATPs, you should also observe other legislative requirements that may be applicable to their importation and exportation. For example, the Prevention and Control of Disease Regulation (Cap. 599A), the Rabies Ordinance (Cap. 421) and the Genetically Modified Organisms (Control of Release) Ordinance (Cap. 607).
For the contents of the relevant legislation, please refer to the website of Hong Kong e-Legislation at https://www.elegislation.gov.hk. For questions relating to the legislation, please obtain legal advice or consult relevant expert.
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Q.15 What is the legal requirement for import of an unregistered ATP for treatment of a particular patient?
A.15
As stated in A1, ATP is included in the definition of pharmaceutical product under the Pharmacy and Poisons Ordinance (Cap. 138). According to Regulation 36(1) of the Pharmacy and Poisons Regulations (Cap. 138A), pharmaceutical products (and thus ATPs) must be registered before they can be sold, offered for sale or distribute or possessed for the purposes of sale, distribution or other use in Hong Kong.
The above requirement is not applicable in the case of possession or use where the ATP is possessed or is to be used for the purpose of treatment by a registered medical practitioner/dentist of a particular patient in accordance with Regulation 36(1A)(ab) of the Pharmacy and Poisons Regulations.
Under the Import and Export Ordinance (Cap. 60), all imports of pharmaceutical products must be covered by an Import Licence. For every single importation, the importer needs to apply for an Import Licence from the Drug Evaluation and Import/Export Control Division of Department of Health. The applicant for Import Licence for an unregistered ATP should be a licensed wholesale dealer on behalf of a registered medical practitioner or dentist.
Application for Import Licence for importation of unregistered ATP for the treatment of a particular patient will be considered on a case by case basis. For further information, please refer to the “Guidance on Application of Import and Export Licences – Advanced Therapy Products” available at the webpage of our office (https://www.drugoffice.gov.hk/eps/do/en/doc/atp_guidance/DO_Guidance_IE_ATP-EN.pdf).
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Q.16 What are the application documents required for importing an unregistered ATP for treatment of a particular patient?
A.16
The importer should apply for an Import Licence from the Drug Evaluation and Import/Export Control Division of the Department of Health. Application for Import Licence for unregistered ATP for the treatment of a particular patient will be considered on a case by case basis. The following supporting documents are required for the application:
letter of a registered medical practitioner or a registered dentist stating the drug name, required quantity, patient’s information (at least with his or her full name), the rationale for the use of unregistered ATP, and for ATPs containing cells or tissues, hospital or Day Procedure Centre where the product is to be administered to the patient
- undertakings from importer and the treating medical practitioner or dentist
- product information (e.g. product insert, description of manufacturing process)
- if the product is an ATP containing cells or tissues, information on the hospital or Day Procedure Centre where the product is to be administered to the patient
- if the product has been registered overseas, proof of that registration
- if the product has not been registered anywhere in the world, documents supporting the therapeutic use and safety of the product
- evidence indicating that the ATP is manufactured in accordance with the standard of Good Manufacturing Practice
- copy of certificate of analysis of the ATP issued by the manufacturer (if certificate of analysis could not be provided, an undertaking stating the justification)
For details, please refer to the “Guidance on Application of Import and Export Licences – Advanced Therapy Products” which is available at the webpage of our office (https://www.drugoffice.gov.hk/eps/do/en/doc/atp_guidance/DO_Guidance_IE_ATP-EN.pdf).
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Licensing |
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Q.17 What licences should I apply for when dealing with ATPs?
A.17
Depending on the nature of your business and the application submitted, various licences stipulated under the Pharmacy and Poisons Ordinance (Cap. 138) and the Antibiotics Ordinance (Cap. 137) will be issued upon application and the decision of the relevant regulatory authorities, which include:
- Wholesale Dealer Licence—for person dealing in wholesale and/or import/export of ATPs
- Licence for Manufacturer of Pharmaceutical Products—for person dealing in the manufacture of ATPs
- Antibiotics Permit—for person dealing in and/or to possess antibiotics
Application for licences to deal in ATPs would be assessed by the relevant licensing committee of the Pharmacy and Poisons Board of Hong Kong on a case by case basis with special focus on nature of each ATP product.
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Q.18 How can I apply for the various licences?
A.18
You may fill in the relevant application forms and provide the supporting documents as listed in the relevant checklists for application. For application guidelines and forms, please refer to the webpage of our office: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html.
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Q.19 If there are any changes in my business after I have received the licence, what should I do?
A.19
You should notify any changes of the business, e.g. name of company, premises, personnel, etc., of a licence to the relevant unit of our Licensing and Compliance Division as soon as possible. The changes may require approval.
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Q.20 Do I need to apply for any licence if I only affix a label stating the ‘product code’ and the ‘unique donation identifier’ to the container of an ATP?
A.20
According to Regulation 29 (1) of the Pharmacy and Poisons Regulations (Cap. 138A), a person must not manufacture any pharmaceutical product on any premises unless he is the holder of a licence to manufacture pharmaceutical products on those premises. Affixing a label that states the product code and the unique donation identifier to the container of an ATP is regarded as manufacturing a pharmaceutical product. Therefore, you need to apply for Licence for Manufacturer (secondary packaging) in order to conduct such operation. For details relating to the application for Licence for Manufacturer for secondary packaging, please refer to the webpage of our office (https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/useful_guidelines_forms.html).
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Others |
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Q.21 How long should I retain the records of transactions involving ATPs and the related documents?
A.21
ATP is a recent development and the scientific development in the field evolves very rapidly. There is little information on its safety and efficacy thus a longer record keeping requirement to ensure sufficient monitoring, tracing and follow-up is required. Licensed wholesale dealers and licensed manufacturers are therefore required to retain the relevant records and documents as stipulated in Regulation 39 of Pharmacy and Poisons Regulations (Cap. 138A) for 30 years after the expiry date of the ATP. If the licensed wholesale dealers or licensed manufacturers cease to operate, the relevant records and documents should be transferred to the Pharmacy and Poisons Board.
For the requirements on record keeping, please refer to the “Guidance on Record Keeping for Licensed Manufacturers and Licensed Wholesale Dealers – Advanced Therapy Products” issued by the Pharmacy and Poisons Board, available at https://www.ppbhk.org.hk/eng/regulation_of_atp.html.
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Q.22 For ATPs, what types of adverse drug reactions should I report to Drug Office?
A.22
Considering the complicated nature and our limited knowledge and experience of ATPs, pharmaceutical industry should report all serious or unexpected adverse drug reactions occurring in Hong Kong. Pharmaceutical industry includes licensed manufacturers, licensed wholesale dealers, the holders of Certificate of Drug/Product Registration and the holders of Certificate for Clinical Trial/Medicinal Test.
Local reports should be submitted to the Adverse Drug Reaction and Adverse Event Following Immunization Unit of our office, as soon as possible and no later than 15 calendar days of receipt of information. Follow-up reports should also be submitted as required.
For details relating to the adverse drug reactions reporting of ATPs, please refer to the “Guidance for Pharmaceutical Industry – Adverse Drug Reaction Reporting Requirements” issued by the Pharmacy and Poisons Board, available at https://www.ppbhk.org.hk/eng/regulation_of_atp.html.
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Q.23 If I have more questions about ATP, can I contact your office?
A.23
You can directly contact the relevant divisions of our office for any specific services or enquiries:
Drug Evaluation and Import/Export Control Division
- Tel: (852) 3974 4175 (Drug Registration Unit)
- Tel: (852) 3974 4180 (Drug Import & Export Control Unit)
Licensing and Compliance Division
- Tel: (852) 3107 2194 (Wholesalers Regulatory Unit)
- Tel: (852) 3107 3477 (Retailers Regulatory Unit)
- Tel: (852) 2961 8162 (Manufacturers Regulatory Unit)
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Q.24 If I have other questions about the regulation of pharmaceutical products in general, what can I do?
A.24
Should you have questions about the regulation of pharmaceutical products, please refer to FAQs for pharmaceutical products in general.
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1 August 2021 |
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Regulation of Advanced Therapy Products
