Hong Kong Clinical Trial and Medicinal Test Certificate: Standard vs Listed Scheme Guide

Quick answer

What is a clinical trial certificate in Hong Kong?

A clinical trial certificate in Hong Kong is a statutory permit issued by the Department of Health (DH) Drug Office under Regulation 36B of the Pharmacy and Poisons Regulations (Cap. 138A). It authorises the conduct of clinical trials on human subjects or medicinal tests on animals using pharmaceutical products, including Advanced Therapy Products (ATPs) since the 2020 Amendment (effective 1 August 2021). Without a valid certificate, conducting a trial or test is an offence carrying a level 2 fine (HK$5,000). Applications are submitted through the Electronic Clinical Trial System (e-CTS) portal. The Drug Office operates two pathways: the Standard Scheme (for pharmaceutical company sponsors, principal investigators, and all medicinal tests) and the Listed Scheme (for sponsor-investigator trials meeting defined low-risk criteria). Current fees are HK$1,420 for the application and HK$1,420 for the certificate. DH's performance pledge targets issuance within three months. Sponsors must obtain ethics committee approval and comply with ICH Good Clinical Practice (GCP). Enquiries: 3974 4180.

Who this applies to

This guide applies to:

• Pharmaceutical companies and research organisations sponsoring clinical trials in Hong Kong
• Sponsor-investigators (typically clinicians at hospitals or universities) conducting investigator-initiated trials
• Principal investigators (PIs) named on trial applications under the Standard Scheme
• Local companies holding a Wholesale Dealer Licence (WDL), antibiotics permit, or dangerous drugs licence who act as trial sponsors
• Academic and hospital research teams planning trials with registered or unregistered pharmaceutical products
• Veterinary or animal research groups conducting medicinal tests on animals (Standard Scheme only)
• Regulatory affairs professionals supporting Hong Kong trial start-up, renewal, or amendment submissions

The certificate requirement covers pharmaceutical products as defined under the Pharmacy and Poisons Ordinance. ATP trials follow additional ATP-specific guidance referenced in the Drug Office Guidance Notes (June 2022). This article does not cover medical device clinical investigations under MDACS — see the MDACS listing articles for device pathways.

Legal basis: Regulation 36B and the Clinical Trial/Medicinal Test Committee

Hong Kong's clinical trial regulatory framework rests on the Pharmacy and Poisons Ordinance (Cap. 138) and its subsidiary Pharmacy and Poisons Regulations (Cap. 138A).

The Clinical Trial/Medicinal Test Committee reviews applications, assesses risk, and recommends certificate grant, amendment, renewal, or refusal. The Drug Office processes submissions received via e-CTS, coordinates ethics documentation, and issues certificates upon Committee approval.

Standard Scheme vs Listed Scheme: overview

The Drug Office operates two application schemes for clinical trial certificates. Choosing the correct scheme determines who may apply, which documents are required, and how the Committee evaluates risk.

Pharmaceutical company or research organisation sponsors must use the Standard Scheme. Sponsor-investigator trials are categorised by risk type (A, B, or C) to determine scheme eligibility.

Type A, B, and C risk categorisation for sponsor-investigator trials

For sponsor-investigator trials, the Drug Office Guidance Notes define three risk categories. The category determines whether the Listed Scheme is appropriate or the Standard Scheme is required.

When in doubt between Type B and Type C, prepare a Standard Scheme dossier unless the Drug Office confirms Listed Scheme eligibility in writing. Type C trials always require the full Standard Scheme documentation set, including drug information, Investigator's Brochure (IB), Certificate of Analysis (CoA), and GMP evidence.

Medicinal tests: Standard Scheme only

Medicinal tests on animals — trials evaluating pharmaceutical products in animal subjects — must be submitted under the Standard Scheme only. The Listed Scheme does not accept medicinal test applications.

Implications for animal research sponsors:

1. Applicant must be a local company with appropriate dealer licensing or the designated principal investigator
2. Full Standard Scheme dossier required (protocol, drug information, CoA, GMP evidence, ethics approval where applicable)
3. Submit via e-CTS using the Standard Scheme application form
4. Same fee structure applies: HK$1,420 application fee + HK$1,420 certificate fee
5. Renewal follows Standard Scheme rules — apply at least four months before certificate expiry

If your protocol involves both human clinical trial and animal medicinal test components, each requires appropriate certificate coverage under Reg 36B.

Who should apply: WDL holders, PIs, and sponsor-investigators

Standard Scheme applicants

Under the Standard Scheme, the applicant must be either:

• A local company holding a valid Wholesale Dealer Licence (WDL) for pharmaceutical products, an antibiotics permit, or a dangerous drugs licence (as applicable to the investigational product); or
• The principal investigator (PI) named in the trial protocol

Pharmaceutical company sponsors typically apply through their licensed local entity. Academic trials sponsored by a hospital or university may have the PI apply directly. Cross-reference the companion article on WDL requirements (wdl-hong-kong) if your organisation lacks a current dealer licence.

Listed Scheme applicants

The Listed Scheme accepts applications from the sponsor-investigator only — the clinician who initiates, designs, and takes scientific responsibility for the trial. A pharmaceutical company cannot apply under the Listed Scheme on behalf of an investigator.

e-CTS submission workflow

All clinical trial and medicinal test certificate applications are submitted through the Electronic Clinical Trial System (e-CTS).

Step-by-step submission

1. Access e-CTS at the Drug Office portal: https://www.drugoffice.gov.hk/CTCInterWeb/jsp/init.action
2. Create or log in to your e-CTS account (first-time users register through the portal)
3. Select scheme type: Standard Scheme or Listed Scheme (sponsor-investigator Type A/B only)
4. Complete the e-CTS application form with trial title, protocol summary, PI details, and product information
5. Upload supporting documents per the checklist for your scheme (see next section)
6. Pay the application fee of HK$1,420 — by credit card, PPS online, or in person at the Kwun Tong shroff (Monday–Friday, 9:00–13:00 and 14:00–17:30; Monday until 17:45)
7. Await Committee review — target three months under DH performance pledge
8. Respond to any deficiency queries from the Drug Office within the requested timeframe
9. Pay the certificate fee of HK$1,420 upon approval
10. Receive the certificate and commence the trial only after ethics committee approval is in place

Ethics committee and ICH GCP requirements

Before trial commencement, sponsors must obtain approval from a recognised ethics committee (EC). The Drug Office FAQ confirms that ICH Good Clinical Practice (GCP) standards apply to clinical trials in Hong Kong. Ethics approval may be submitted with the initial application or provided when available — but the trial must not begin without valid EC approval.

Payment options

Fees stated are current per the June 2022 Guidance Notes. Verify fee amounts at submission time via the Drug Office forms hub or by calling 3974 4180.

Document checklists: Standard Scheme vs Listed Scheme

Standard Scheme — initial application (minimum dossier)

For GMP documentation expectations, see the companion article on GMP compliance in Hong Kong (gmp-compliance-hong-kong).

Standard Scheme — renewal application (additional documents)

Listed Scheme — initial application (minimum dossier)

Listed Scheme dossiers do not require PI CV, drug information/IB, CoA, or GMP evidence — the risk assessment form and EC approval carry greater weight in Committee review.

Listed Scheme — renewal application (additional documents)

Renewal, amendments, and the three-month performance pledge

Certificate renewal

Renewal applications must be submitted at least four months before the current certificate expires. Late renewal risks a gap in certificate validity, during which the trial cannot legally continue.

Renewal dossiers follow the same scheme-specific checklists above, with the addition of the previous certificate and a progress report. Submit renewal via e-CTS using the renewal application function.

Department of Health performance pledge

The Department of Health publishes a performance pledge for Drug Office services. For clinical trial certificates, DH commits to granting the certificate within three (3) months of receiving a complete application. This is a service target, not a statutory deadline — incomplete dossiers or Committee queries may extend the timeline.

Plan submission timelines accordingly: allow three months for initial certificate plus time for ethics approval and site preparation before your planned first-patient-in date.

Advanced Therapy Products (ATPs)

Trials involving Advanced Therapy Products fall within the pharmaceutical product scope of Reg 36B following the 2020 Amendment (effective 1 August 2021). ATP sponsors use the same Standard or Listed Scheme pathways, but the Drug Office references separate ATP-specific guidance for additional documentation requirements. If your investigational product is a cell therapy, gene therapy, or tissue-engineered product, consult the ATP guidance linked from the Drug Office clinical trial forms hub alongside this certificate process.

Relationship to pharmaceutical registration and CMPR

A clinical trial certificate authorises conduct of a trial — it is not a marketing authorisation. Products used in trials may be unregistered (Type C) or registered (Type A). For the separate pathway to register a pharmaceutical product for commercial supply in Hong Kong, see professional-guide-pharmaceutical-registration.

Hong Kong's Preparatory Office for the Centre for Medical Products Regulation (CMPR) aims to strengthen local regulatory capacity, including primary evaluation of new drugs based on local clinical trial data. Robust CTC infrastructure — including e-CTS and the Clinical Trial/Medicinal Test Committee — supports that policy direction. See hkg-cmpr-primary-evaluation-pharmaceutical-registration-hong-kong for CMPR context.

Import of investigational products for trials may additionally require compliance with import and export regulations — cross-reference import-export-regulations when planning supply chain logistics.

Common pitfalls

1. Choosing the wrong scheme — pharmaceutical company sponsors cannot use the Listed Scheme; sponsor-investigator Type C trials must use Standard Scheme
2. Submitting medicinal tests under Listed Scheme — animal medicinal tests are Standard Scheme only; Listed Scheme applications for medicinal tests will be rejected
3. Missing the four-month renewal window — certificate expiry creates a legal gap; trials must pause until renewal is granted
4. Starting before ethics approval — certificate grant does not replace EC approval; both must be in place before first subject enrolment
5. Incomplete GMP evidence (Standard Scheme) — missing CoA or GMP documentation is a common deficiency query for company-sponsored trials
6. English-only patient materials — patient information and consent forms must be in English and Chinese, or Chinese only
7. Assuming certificate equals registration — a CTC permits trial conduct only; commercial distribution requires separate registration under Cap. 138
8. Ignoring ATP supplementary guidance — ATP trials require additional documents beyond the standard checklists

FAQ

What is the difference between the Standard Scheme and Listed Scheme for Hong Kong clinical trial certificates?

The Standard Scheme applies to pharmaceutical company sponsors, research organisations, principal investigators, all medicinal tests, and high-risk Type C sponsor-investigator trials. It requires a full dossier including drug information, CoA, and GMP evidence. The Listed Scheme is available to sponsor-investigators only for qualifying Type A and some Type B low-to-moderate-risk trials, with a streamlined dossier centred on a risk assessment form. Listed Scheme does not accept medicinal test or unregistered drug trials.

Who applies for a clinical trial certificate in Hong Kong?

Under the Standard Scheme, the applicant is a local company with a WDL, antibiotics permit, or dangerous drugs licence, or the principal investigator. Under the Listed Scheme, only the sponsor-investigator (the clinician who initiates and leads the trial) may apply. Pharmaceutical companies cannot file Listed Scheme applications on behalf of investigators.

How much does a Hong Kong clinical trial certificate cost?

The current fees per Drug Office Guidance Notes (June 2022) are HK$1,420 for the application and HK$1,420 for the certificate upon approval. Payment is accepted online via credit card or PPS through e-CTS, or in person at the Kwun Tong shroff. Renewal applications incur the same fee structure.

How long does the Drug Office take to issue a clinical trial certificate?

The Department of Health performance pledge targets granting a clinical trial certificate within three months of receiving a complete application. Incomplete dossiers, Committee queries, or missing ethics documentation can extend the timeline. Plan at least three months before your intended trial start date.

Do medicinal tests on animals use the Listed Scheme?

No. Medicinal test applications (trials on animals) must be submitted under the Standard Scheme only. The Listed Scheme is restricted to sponsor-investigator clinical trials on human subjects meeting Type A or qualifying Type B risk criteria.

What portal is used for clinical trial applications in Hong Kong?

All applications are submitted through the Electronic Clinical Trial System (e-CTS) at https://www.drugoffice.gov.hk/CTCInterWeb/jsp/init.action. The portal handles new applications, renewals, amendments, and online fee payment. Forms and guidance documents are also available from the Drug Office clinical trial forms hub.

Is ethics committee approval required before applying for a certificate?

Ethics committee approval should be submitted with the application when available. However, the trial must not commence until valid ethics committee approval is in place. ICH GCP standards apply. The Drug Office FAQ confirms that EC approval is a prerequisite for trial start even if it is not yet available at the time of certificate application.

What happens if a clinical trial is conducted without a valid certificate?

Conducting a clinical trial or medicinal test without a valid certificate under Regulation 36B is an offence under the Pharmacy and Poisons Regulations, carrying a fine at level 2 (HK$5,000). Sponsors must ensure certificate validity throughout the trial period and renew at least four months before expiry to avoid gaps.

Official sources

• Department of Health, Drug Office — Guidance Notes on Application for Certificate for Clinical Trial/Medicinal Test (June 2022): https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/Guidance_Notes_en_Version.pdf
• Department of Health, Drug Office — FAQ on Clinical Trial Certificate: https://www.drugoffice.gov.hk/eps/do/en/doc/guidelines_forms/FAQ_modified_en.pdf
• Department of Health, Drug Office — Clinical trial forms and guidance hub: https://www.drugoffice.gov.hk/eps/do/en/pharmaceutical_trade/guidelines_forms/clinicalTrial.html
• Department of Health — Electronic Clinical Trial System (e-CTS): https://www.drugoffice.gov.hk/CTCInterWeb/jsp/init.action
• Department of Health — Useful forms index (Clinical Trial/Medicinal Test Committee contact 3974 4180): https://www.dh.gov.hk/english/useful/useful_forms/useful_forms.html
• Department of Health — Performance pledges (Drug Office clinical trial certificate: 3 months): https://www.dh.gov.hk/english/aboutus/aboutus_pp/aboutus_pp.html
• Department of Health — Drug Office main page (Cap. 138 enforcement): https://www.dh.gov.hk/english/main/main_ps/main_ps.html