Frequently Asked Questions

General Information

• Q.1 What is "1+" mechanism?

  A.1 The "1+" mechanism that came into effect on 1 November 2023 targeted for new drugs used for treatment of life-threatening or severely debilitating diseases. The "1+" mechanism was extended to all new drugs from 1 November 2024, including all new chemical or biological entities (NCEs) and new indications, and vaccines and advanced therapy products.
  
  Under the "1+" mechanism, new drugs which are supported by local clinical data and recognised by local relevant experts can be applied for registration in Hong Kong by submitting approval from the drug regulatory authority of one of the reference countries (instead of two in the past).




• Q.2 What are the differences in documentary requirements for application of registration between the extended "1+" mechanism and the previous one?

  A.2 The extended "1+" mechanism is applicable for all new drugs indicating for any diseases. Applicants are required to provide documentary evidence (e.g. the product is approved with orphan drug designation, breakthrough therapy designation, priority review designation, or equivalent) to substantiate the new drugs under application of registration have prominent clinical benefit and are marketed in any of the reference countries as well as local clinical data (e.g. clinical studies, case reports, case series, real-world data, etc.) or clinical data generated from Chinese and/or Asian populations related to the proposed indication(s) and posology of the product.
  
  For details, please refer to the section 4.1.2 of the "Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity" issued by the Pharmacy and Poisons Board of Hong Kong:
  www.ppbhk.org.hk/eng/files/Guidance_on_Reg_of_Pharm_Prod_Containing_New_Chem_or_Bio_Entity_en.pdf




• Q.3 How long does it take for my application submitted under the "1+" mechanism to be evaluated?

  A.3 A target timeline for the review process of application for registration of pharmaceutical products containing an NCE under the "1+" mechanism, namely the "stop-clock" mechanism that has come into effect since 1 May 2024, has been set.
  
  The target processing time - i.e. the time period between the acceptance of an application upon payment of the prescribed fee and the decision made by the Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances Committee (Registration Committee) - of an application under the "1+" mechanism is 150 working days. Under the target processing timeline, the "stop-clock" will be paused as evaluation of the application is paused upon request for written response sent to the applicant for supplementary documentary evidence. The "stop-clock" and evaluation of the application will be resumed upon receipt of a response from the applicant.
  
  For details, please refer to the illustration of "stop-clock" mechanism for "1+" mechanism during the pilot phase:
  www.drugoffice.gov.hk/eps/do/en/doc/stop_clock_2024.03.25.pdf




• Q.4 If my product applied under "1+" mechanism has received more than one reference approval, will the licensing conditions same as that of an NCE product with approval in two or more reference countries under ordinary pathway?

  A.4 The Registration Committee will consider the worldwide registration status of the product when determining the licensing conditions, which are subject to the Registration Committee’s decision.
  
  In general, products under "1+" mechanism with only one reference approval are subject to licensing conditions such as reporting all serious or unexpected adverse drug reactions of the product occurring in Hong Kong, sales and supply restriction to institutions or registered medical practitioners, etc.
  
  As an incentive, applicants for product registration under "1+" mechanism may opt for using electronic product information to replace physical packaging insert for healthcare professionals.

Eligibility of "1+" mechanism

• Q.5 My product is an over-the-counter product in the exporting country. Will it be eligible for "1+" mechanism?

  A.5 The "1+" mechanism has already been extended to all drugs.
  
  A product is eligible for the "1+" mechanism as long as the criteria set out in section 4.1.2 of the "Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity" are fulfilled.
  
  For details, please refer to the section 4.1.2 of the "Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity": www.ppbhk.org.hk/eng/files/Guidance_on_Reg_of_Pharm_Prod_Containing_New_Chem_or_Bio_Entity_en.pdf





• Q.6 Will my product be eligible for "1+" mechanism if there are no local clinical data?

  A.6 You may provide clinical data generated from Chinese and/or Asian populations representative of the local patient population(s) in Hong Kong that are related to the proposed indication(s) and posology of your product.
  
  Those data should be gathered from clinical studies, in which the drug has been shown in accordance with ICH E5 "Ethnic factors in the acceptability of foreign clinical data" to be ethnically insensitive and extrinsic factors (such as medical practice and conduct of clinical trials) in these region(s) are generally similar to those in Hong Kong.
  
  The local expert you engage to write an assessment report should also include an evaluation of the data in the report.





• Q.7 Will my product be eligible for "1+" mechanism if it is approved in more than one of the reference countries?

  A.7 Your product will be eligible for "1+" mechanism as long as it is approved and marketed in any of the reference countries and has fulfilled other criteria set out in section 4.1.2 of "Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity" (i.e. to provide relevant local clinical data).
  
  For details, please refer to section 4.1.2 of the "Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity":
  www.ppbhk.org.hk/eng/files/Guidance_on_Reg_of_Pharm_Prod_Containing_New_Chem_or_Bio_Entity_en.pdf





• Q.8 What is considered equivalent to the orphan drug designation, breakthrough therapy designation and priority review designation?

  A.8 You should provide evidence demonstrating prominent clinical benefits, e.g. showing significant therapeutic effects and/or making improvements in patients’ quality of life.
  
  You may make reference to the considerations commonly taken by the drug regulatory authorities of the reference countries in granting these designations. These include:

  • advantage or contribution to patients’ care;
  • substantial improvement on a clinically significant endpoint;
  • suitability for patients for whom current treatments do not work;
  • improvements in patients’ outcome when added to current treatment; or
  • comparable therapeutic effects while being significantly easier or more convenient to use.

GMP requirements

• Q.9 Is the compliance with Good Manufacturing Practices (GMP) standards promulgated by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) mandatory for registration under the "1+" mechanism?

  A.9 All the new applications for registration of pharmaceutical products, including those submitted under "1+" mechanism, must include evidence that the manufacturers comply with the PIC/S GMP standards.
  
  For details, please refer to the "Questions and Answers on PIC/S GMP Requirements for Registration of Imported Pharmaceutical Products":
  www.ppbhk.org.hk/eng/doc/guidelines_forms/FAQ_for_PICS_implementation_english.pdf





• Q.10 I do not have evidence showing that the manufacturer of my product to be applied for registration under "1+" mechanism has complied with PIC/S GMP. I intend to invite the Drug Office to conduct a GMP inspection of the manufacturer. When should I make a request for the inspection?

  A.10 You may submit a request for GMP inspection by the Drug Office and an application for product registration under the "1+" mechanism in parallel. Alternatively, you may invite another PIC/S Participating Authority to conduct the inspection.
  
  For details, please refer to the "Questions and Answers on PIC/S GMP Requirements for Registration of Imported Pharmaceutical Products":
  www.ppbhk.org.hk/eng/doc/guidelines_forms/FAQ_for_PICS_implementation_english.pdf

Dossier requirements

• Q.11 Can I submit the Common Technical Document and other supporting documents in Chinese only?

  A.11 Documents in either English or Chinese are accepted. You are encouraged to consider your target stakeholders, e.g. experts that provide advice for applications, local prescribers, other healthcare professionals and patients when deciding the language of the submitted documents.





• Q.12 Who can write an assessment report on the safety and efficacy of my product to be applied under the "1+" mechanism? What have to be included in the assessment report?

  A.12 You should engage a local expert with fellowship or equivalent qualification who has at least 5 years of experience in the field relevant to the product to write an assessment report on the safety and efficacy of the product.
  
  The assessment report should include an evaluation on the clinical data of the product as required under "1+ mechanism", a review of the global and local epidemiology of the disease(s), international and local treatment paradigms of the disease(s), and safety and efficacy of the product.
  
  You may refer to the suggested template of the assessment report at:
  www.drugoffice.gov.hk/eps/do/en/doc/Local_expert_assessment_eval_rpt.pdf





• Q.13 Where can I find a list of local experts who can write the assessment report on the safety and efficacy of my product?

  A.13 The Drug Office does not provide a list of local experts who can write the assessment report. You will have to find a local expert with fellowship or equivalent qualification who has at least 5 years of experience in the field relevant to your product in order to fulfill the requirement.
  
  You should also submit a declaration for conflict of interest by the expert along with the assessment report.





• Q.14 Can an expert from outside of Hong Kong write the assessment report?

  A.14 A local expert with fellowship or equivalent qualification and at least 5 years of experience in the field relevant to the product should write the report, providing assessment on, among others, the local epidemiology, local treatment paradigms and local clinical data.





• Q.15 Are there any alternatives if the Certificate of a Pharmaceutical Product as evidence of approval for registration and marketing in the reference country is unavailable?

  A.15 Official evidence of registration approval and marketing status of the product, e.g. electronic copy and original or certified true copies of Free Sale Certificates / Certificate of a Pharmaceutical Product, should be provided, showing that the approved product is marketed in any of the reference countries. Other documentary evidence issued by drug regulatory authorities of the reference countries may also be accepted on a case-by-case basis.





• Q.16 Can I submit redacted assessment reports issued by the regulatory authority of the reference country to support my application under "1+" mechanism?

  A.16 You should make the best effort to obtain the complete and unredacted assessment reports (translated to English/ Chinese, if applicable) from the regulatory authority that granted the approval and if any, designation.
  
  In case an unredacted assessment report is not available, you are expected to provide clarifications on the redacted information and other supporting documents which may include, but not limited to, documents/ correspondence on questions and answers between you/your associated company as applicant in the reference country and the concerned authority during the authority’s evaluation and/or at meetings relevant to the product’s safety, efficacy or quality.
  
  Evaluation by the Drug Office on all the submitted evidence, as a whole, will be conducted on a case-by-case basis.