Hong Kong CMPR and Primary Evaluation: Future Pharmaceutical Registration Framework

Quick answer

What is the Hong Kong Centre for Medical Products Regulation (CMPR) and primary evaluation?

The Hong Kong Centre for Medical Products Regulation (CMPR) is a planned regulatory authority announced in the Chief Executive's 2023 Policy Address. When established, CMPR will register drugs and medical devices under a "primary evaluation" approach — meaning the authority will directly approve registration applications in Hong Kong based on clinical trial data, without relying on registration approval from other drug regulatory authorities. The goal is to accelerate clinical use of new medical products, foster research and development and local clinical trials, and develop Hong Kong into an international health and medical innovation hub. A Preparatory Office for the CMPR was set up under the Department of Health (DH) in June 2024 to study the regulatory regime, propose establishment steps, review legislation, and advise the Steering Committee on Health and Medical Innovation and Development (chaired by the Secretary for Health). Important: CMPR is not yet operational as of mid-2026. Medicines today remain registered under the Pharmacy and Poisons Ordinance (Cap. 138) through the Drug Office and Pharmaceutical Registration System (PRS). Sponsors must continue using current pathways until new CMPR legislation takes effect.

Who this applies to

This guide is for regulatory affairs professionals, pharmaceutical sponsors, medical device manufacturers, clinical trial organisations, and investors planning Hong Kong market access under the future CMPR framework.

Product scope: The Policy Address and DH Preparatory Office materials refer to medical products — both drugs and medical devices. This article focuses on the pharmaceutical registration implications of primary evaluation while noting the parallel device dimension.

2023 Policy Address: the CMPR policy anchor

Hong Kong's CMPR initiative originates in the Chief Executive's 2023 Policy Address. The Government stated it would leverage Hong Kong's medical strengths with the long-term objective of establishing an authority — the Hong Kong Centre for Medical Products Regulation (CMPR) — to register medical products under the primary evaluation approach.

The stated policy rationale, as published on the DH Preparatory Office page, includes:

• Accelerating clinical use of new drugs and medical devices in Hong Kong
• Fostering industries relating to research and development and clinical trials of medical products
• Developing Hong Kong into an international health and medical innovative hub

This is a structural policy shift, not a tweak to existing registration forms. It envisions a dedicated centre that evaluates products on their own scientific merits using local clinical trial evidence, rather than treating overseas marketing authorisation as the primary gate for Hong Kong registration.

Timeline caveat (preparatory phase)

Treat all CMPR timelines as indicative policy direction until DH publishes enabling legislation and operational guidance. Do not plan commercial launches assuming primary evaluation is available without confirming the legal commencement date.

What is primary evaluation?

Primary evaluation is the term DH uses on the CMPR Preparatory Office page to describe the future registration model. In DH's formulation:

…to directly approve applications for registration of medical products in Hong Kong based on clinical trial data, without relying on registration approval from other drug regulatory authorities.

Primary evaluation vs reference-country reliance

Hong Kong's current pharmaceutical registration system under Cap. 138 typically expects sponsors to submit dossiers demonstrating safety, efficacy, and quality. In practice, many applications lean on overseas clinical study reports, post-marketing study results, and reference-country marketing approvals as part of the evidence package evaluated by the Drug Office through PRS.

Primary evaluation represents a conceptual inversion for eligible products: the Hong Kong regulator would conduct the substantive scientific assessment using clinical trial data — including data generated in Hong Kong — as the foundation for approval, rather than deferring to another authority's registration decision as the decisive factor.

Primary evaluation does not mean trials alone replace quality and manufacturing documentation. DH has not yet published the full technical dossier requirements for the future regime. Expect a complete CTD-style package where clinical modules are evaluated primarily on Hong Kong-generated or Hong Kong-accepted trial evidence.

Promotional materials

DH publishes a booklet titled "The Hong Kong Centre for Medical Products Regulation — Towards Primary Evaluation" on the CMPR Preparatory Office page, alongside a leaflet and video on building Hong Kong into an international health and medical innovation hub. These materials explain the policy vision but do not constitute operational registration guidance.

Preparatory Office for the CMPR (June 2024)

The Preparatory Office for the Hong Kong Centre for Medical Products Regulation was established under the Department of Health in June 2024. It is the interim body responsible for translating Policy Address intent into a workable regulatory framework.

Mandate — four core workstreams

Per the DH Preparatory Office page, the Preparatory Office's specific work includes:

1. Comprehensively studying and planning a regulatory and approval regime for drugs and medical devices suitable for Hong Kong
2. Putting forward proposals and steps for the establishment of the CMPR
3. Conducting a review on the need for amending existing legislations to promote the development of medical products regulation
4. Making recommendations to the Steering Committee on Health and Medical Innovation and Development (chaired by the Secretary for Health), and maintaining close communication with stakeholders

The Preparatory Office is not a registration authority. It does not accept marketing authorisation applications, issue HK- registration numbers, or replace the Drug Office for any product type during the preparatory phase.

Steering Committee governance

Recommendations flow to the Steering Committee on Health and Medical Innovation and Development, chaired by the Secretary for Health. This governance structure signals that CMPR establishment is a whole-of-government health innovation initiative, not a routine Drug Office procedural update.

Stakeholders — industry associations, hospitals, universities, and patient groups — should monitor Preparatory Office communications and related documents pages for consultation opportunities, draft legislative proposals, and transition timelines.

Current Cap. 138 registration vs future CMPR

Until CMPR legislation commences, all medicines placed on the Hong Kong market must be registered under Cap. 138. DH's registration information page confirms that medicines are required to be registered to ensure they are safe, effective, and of good quality.

Today's pharmaceutical registration pathway

For step-by-step PRS submission, portal navigation, and dossier structure, see professional-guide-pharmaceutical-registration.

Parallel pathways that remain relevant today

Several existing mechanisms address overlapping but distinct needs. Do not conflate them with CMPR primary evaluation:

CMPR primary evaluation is a future third pillar in the policy landscape: a standalone regulator that approves products on local clinical evidence without requiring overseas registration as the decisive input.

How primary evaluation connects to clinical trials

Primary evaluation is logically dependent on clinical trial capacity in Hong Kong. If the future CMPR approves drugs based on clinical trial data without deferring to overseas authorities, sponsors need:

• Trials conducted to ICH GCP standards with Hong Kong ethics committee approval
• Valid clinical trial certificates under Regulation 36B (Cap. 138A), submitted via e-CTS
• Robust local investigator and hospital infrastructure to generate registrable evidence
• Quality and manufacturing modules supporting the clinical findings

The Drug Office currently administers trial certificates through the Standard Scheme and Listed Scheme, with fees of HK$1,420 per application and certificate and a three-month performance pledge. Type C trials using unregistered drugs require the Standard Scheme with full dossier review — the category most aligned with generating novel evidence for a future primary evaluation submission.

Sponsors planning innovator programmes should start trials now under the existing framework. Trial data collected before CMPR establishment may become part of transition arrangements — but no transition rules are published yet. Maintain complete trial master files and GCP documentation regardless.

Medical devices under the future CMPR

The Policy Address explicitly includes medical devices alongside drugs within CMPR's scope. Today, medical devices follow the Medical Device Administrative Control System (MDACS) administered by the Medical Device Division (MDD) — a voluntary listing framework covering Class II–IV general medical devices and Class B–D IVDMD, with Class I/A outside current listing scope.

Future CMPR integration raises open questions the Preparatory Office is studying:

• Whether device primary evaluation would mirror the drug model (local clinical investigation data as the approval basis)
• How MDACS listing, TR-003/TR-006 classification, and MDIS submissions transition to statutory CMPR control
• Whether Conformity Assessment Body (CAB) pathways persist or are replaced

For current device obligations, see medical-device-regulation-hong-kong-mdacs and related MDACS listing articles. Device sponsors should monitor Preparatory Office publications for consultation papers affecting MDACS.

What sponsors should do during the preparatory phase

CMPR is policy-forward but commercially inactive. Practical planning steps for regulatory teams:

Step-by-step preparatory-phase workflow

1. Confirm current legal requirement — any product supplied in Hong Kong still needs Cap. 138 registration (drugs) or appropriate MDACS/trader compliance (devices) today
2. Map portfolio against future primary evaluation eligibility — identify innovator assets where local trial data could support a standalone HK approval versus products better suited to reference-country PRS dossiers
3. Establish or expand Hong Kong clinical trial programmes — obtain Reg 36B certificates via e-CTS; align protocols with future evidence needs
4. Monitor Preparatory Office updates — bookmark the CMPR news and related documents pages for legislative drafts and stakeholder consultations
5. Engage the Steering Committee process indirectly — participate in industry consultations when DH invites comment on proposed regulatory regimes
6. Maintain parallel PRS strategy — do not delay Cap. 138 submissions waiting for CMPR; use 1+ mechanism where eligible for interim patient access
7. Document assumptions for leadership — flag that primary evaluation timelines are uncertain and budget accordingly
8. Plan GBA and export strategies separately — cross-border measures under gba-hk-registered-drugs-measure operate under distinct legal bases from CMPR

Decision matrix: which pathway applies today?

Checklist: preparatory-phase compliance and readiness

• Verify every commercial drug SKU holds valid HK-XXXXX Cap. 138 registration before supply
• Confirm PRS dossiers are current for variations, renewals, and safety updates via Drug Office
• Identify innovator assets where local clinical trial data is strategically valuable
• Obtain clinical trial certificates (Reg 36B) before initiating HK human trials or medicinal tests
• Submit trial applications through e-CTS with correct Standard vs Listed Scheme selection
• Evaluate 1+ mechanism eligibility for qualifying new drugs needing pre-registration access
• For devices, confirm MDACS classification (TR-003/TR-006) and listing obligations
• Subscribe to CMPR Preparatory Office news page for legislative and consultation updates
• Brief commercial teams that CMPR is not accepting applications — avoid contractual commitments tied to primary evaluation dates
• Maintain a regulatory intelligence log tracking Preparatory Office publications and Steering Committee announcements

Common pitfalls

1. Assuming CMPR is already accepting registrations — only the Preparatory Office exists; Drug Office PRS remains mandatory for medicines
2. Confusing clinical trial certificates with marketing authorisation — Reg 36B permits trial conduct, not commercial sale
3. Delaying PRS submissions to wait for primary evaluation — no commencement date is published; delay risks unregistered supply offences
4. Treating overseas MA as sufficient for future primary evaluation — the policy definition explicitly states approval will not rely on other authorities' registration
5. Ignoring device scope — CMPR covers medical devices; MDACS obligations continue independently during preparatory work
6. Overlooking 1+ mechanism for eligible innovators — interim access may be available now while CMPR is being built
7. Missing stakeholder consultation windows — Preparatory Office work includes stakeholder communication; late engagement reduces influence on regime design
8. Equating GBA measures with CMPR — GBA registered drugs policy addresses cross-border supply, not domestic primary evaluation

FAQ

What is CMPR in Hong Kong?

The Hong Kong Centre for Medical Products Regulation (CMPR) is a planned authority announced in the 2023 Policy Address to register drugs and medical devices using primary evaluation — approving products based on clinical trial data without relying on other regulators' registration decisions. A Preparatory Office under DH was established in June 2024. CMPR is not yet operational; medicines remain registered under Cap. 138 via the Drug Office.

What is primary evaluation for drug registration?

Primary evaluation means the Hong Kong regulator directly approves registration applications using clinical trial data as the evidentiary foundation, without depending on registration approval from other drug regulatory authorities. It aims to accelerate access to new drugs and medical devices and support Hong Kong as a health innovation hub. Detailed dossier requirements and eligibility criteria are not yet published.

When will CMPR replace the current Drug Office registration system?

DH has not announced an operational start date for CMPR. The Preparatory Office (established June 2024) is studying the regulatory regime, proposing establishment steps, and reviewing legislative amendments. Until new laws commence, Cap. 138 registration through the Drug Office and PRS remains mandatory. Monitor the CMPR Preparatory Office news page for updates.

How does CMPR relate to clinical trials in Hong Kong?

Primary evaluation depends on local clinical trial data. Sponsors must obtain clinical trial certificates under Regulation 36B (Cap. 138A) via the e-CTS portal before conducting trials. Robust GCP-compliant trials generate the evidence a future CMPR would evaluate. Trial certificates authorise research — they do not replace Cap. 138 marketing authorisation for commercial supply.

Can I register a drug in Hong Kong today without overseas approval?

Yes, under the current system — PRS accepts dossiers with clinical study reports and quality documentation regardless of overseas MA status, though overseas data is commonly submitted. The future primary evaluation model explicitly de-emphasises reliance on overseas registration. For interim patient access to selected new drugs, evaluate the 1+ mechanism separately.

Does CMPR cover medical devices as well as pharmaceuticals?

Yes. The 2023 Policy Address and DH Preparatory Office materials refer to medical products including both drugs and medical devices. Devices currently fall under MDACS via the Medical Device Division. How device primary evaluation will operate — and how MDACS transitions to CMPR — is part of the Preparatory Office's study and planning work.

What is the Preparatory Office doing now?

The Preparatory Office is: (1) studying and planning a suitable regulatory regime; (2) proposing CMPR establishment steps; (3) reviewing legislative amendment needs; and (4) recommending to the Steering Committee on Health and Medical Innovation and Development while engaging stakeholders. It does not process registration applications.

How does CMPR differ from the GBA registered drugs measure?

CMPR is a future domestic registration authority using primary evaluation based on local clinical data. The GBA registered drugs measure addresses cross-border supply of already HK-registered medicines in Greater Bay Area contexts. They serve different policy objectives and legal bases. See gba-hk-registered-drugs-measure for GBA-specific requirements.

Official sources

• Department of Health — Preparatory Office for the Hong Kong Centre for Medical Products Regulation: https://www.dh.gov.hk/english/main/main_pocmpr/main_pocmpr.html
• Department of Health — CMPR Preparatory Office latest updates: https://www.dh.gov.hk/english/main/main_pocmpr/main_pocmpr_news.html
• Department of Health — CMPR related documents and booklets: https://www.dh.gov.hk/english/main/main_pocmpr/main_pocmpr_related_documents.html
• Department of Health — Registration of Medicines in Hong Kong (Cap. 138): https://www.dh.gov.hk/english/useful/useful_registration/useful_registration.html
• Department of Health — Drug Office main page: https://www.dh.gov.hk/english/main/main_ps/main_ps.html