Guangdong MPA Implements 2026 Guideline for Importing Hong Kong and Macao Drugs into the Greater Bay Area

On July 20, 2026, the Guangdong Provincial Medical Products Administration (GDMPA) and Guangdong Provincial Health Commission announced a new 2026 Guideline for the Application of Drugs Imported from Hong Kong and Macao in the nine mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area (GBA). The guideline, jointly issued on June 25, 2026, took effect on August 8, 2026, replacing the 2024 version.

The revised framework takes a more structured approach to evaluating clinically urgent drugs. For first-time applications, it raises expectations for demonstrating unmet clinical need, benefit-risk balance, and readiness for safe clinical use. Products already approved under the scheme, however, continue to benefit from the streamlined repeat-application process.

Key Changes at a Glance

• 2024 guideline replaced: The previous application guideline was replaced when the new guideline took effect on August 8, 2026.
• Higher evidence requirements for first-time applications: Clinical need assessments are more structured and detailed, with benefit-risk assessments introduced.
• Greater emphasis on global and post-marketing experience: Global utilization, Asian patient experience and post-marketing safety information have a more prominent role in supporting the benefit-risk assessment.
• Stronger institutional requirements: Hospitals must demonstrate adequate governance, training and risk-management capabilities.
• More detailed ethics documentation: Applications must provide clearer evidence of ethics oversight and informed consent.

From Pilot Pathway to More Structured Review

The GBA Connect Scheme was established to improve access to urgently needed drugs and medical devices that are available in Hong Kong and Macao but have not yet been approved for marketing in mainland China.

As the scheme has developed, Guangdong has progressively formalized the requirements and procedures governing the importation and use of these products. The 2026 guideline continues this shift by integrating a newly established directory management mechanism into the application framework and setting clearer expectations for the evidence required to support new applications.

What First-Time Applicants Need to Demonstrate

Rather than simply demonstrating that a product addresses an unmet need, applicants must now provide a structured assessment of its value relative to existing treatment options and support its use with broader safety and utilization data.

1. Enhanced Clinical Need Assessment

Applicants must establish the product's clinical necessity against the treatment landscape in China.

The clinical need assessment should cover:

• Disease burden and epidemiology
• Current treatment options
• Unmet clinical needs
• Guideline-supported treatment approaches
• Comparison with therapies already available in China

This creates a more evidence-driven assessment of whether the product provides a meaningful option for patients who cannot be adequately treated with existing therapies.

2. New Benefit-Risk Evaluation Framework

The 2026 framework introduces a formal benefit-risk assessment.

Applicants should provide information on:

• Global marketing history
• Global utilization
• Experience in Asian populations
• Safety updates
• Serious adverse reactions
• Risk mitigation measures

 Together, this information should support an assessment that the expected clinical benefits outweigh the potential risks for the proposed use.

3. Stronger Institutional Readiness Requirements

The higher evidentiary threshold for the product is matched by greater expectations for the healthcare institution responsible for its use.

Designated hospitals must demonstrate that they have the systems and personnel needed to manage the product safely, including:

• Appropriate governance structures
• Qualified healthcare personnel
• Relevant training records
• Adverse event management capabilities
• Risk-control procedures

Accordingly, the application should address both the clinical justification for use of the product and the designated medical institution’s capability to manage its use safely.

4. More Detailed Ethics Review Requirements

This institutional focus also extends to ethics oversight. Applications must provide documentation addressing:

• Ethics committee composition
• Conflict-of-interest management
• Review procedures and conclusions

Informed consent materials must also clearly state that the product has not been approved for marketing in mainland China.

Review Pathways Depend on Product Status

The revised framework differentiates the review process according to whether a product is already included in the urgent drug directory.

Drugs Outside the Urgent Drug Directory (Typically First-Time Applications)

Products not yet included in the urgent drug directory generally undergo the more comprehensive review process:

1. Application acceptance and dossier review
2. Technical review and expert evaluation organized by the Guangdong Medical Products Administration (GDMPA)
3. Guangdong Health Commission review within 10 working days
4. GDMPA approval decision within 10 working days

The 15-working-day expert review period is excluded from the statutory review clock.

For drugs outside the directory, the review process includes technical/expert review, followed by review by the Guangdong Provincial Health Commission and an approval decision by the GDMPA. The expert review period is generally 15 working days and is not counted within the relevant administrative review time limits. Applicant supplementation time is also excluded.

In practice, the sequential review stages may result in an overall processing period of approximately 35 working days, excluding applicant supplementation time.

Drugs Included in the Urgent Drug Directory (Repeat Applications)

 For eligible subsequent applications involving products already approved under the scheme and included in the urgent drug directory, the submission requirements are substantially simplified. The designated medical institution can rely on information concerning previous importation and use, including relevant safety monitoring and risk-management activities, together with the other materials required under the applicable streamlined pathway.

The process is as follows:

1. The designated healthcare institution submits the application through the provincial licensing system
2. Guangdong authorities conduct an initial review to confirm that the application materials are complete
3. The Guangdong Health Commission reviews institutional qualifications, ethics approval, clinical need and management systems within 5 working days
4. The GDMPA issues an approval decision within 5 working days, based on the review outcome

 For eligible directory-listed products, the streamlined pathway provides for review by the Guangdong Provincial Health Commission within 5 working days, followed by a GDMPA approval decision within 5 working days. Applicant supplementation time is not included in these review periods.

For companies managing recurring access to the GBA market, maintaining complete records of product utilization, safety monitoring and risk-management activities will therefore become increasingly important.

What Pharmaceutical Companies Should Do Now

The practical implications of the revised framework depend largely on where a product sits within the GBA Connect Scheme lifecycle.

For Products Not Yet Approved Under the Scheme: Build the Evidence Case Earlier

Companies should treat clinical need, comparative treatment evidence and benefit-risk assessment as core components of the regulatory strategy. In particular, they should demonstrate why therapies available in mainland China do not adequately address the target patient population, using global utilization data, Asian patient experience and post-marketing safety information to strengthen the case for clinical relevance and a favorable benefit-risk profile.

For Established Products: Maintain a Strong Use Record

Companies with products already approved under the scheme have an opportunity to benefit from the simplified repeat-application pathway.

To make that process efficient, sponsors and healthcare institutions should maintain organized records covering:

• Importation and utilization
• Safety monitoring
• Serious adverse events
• Risk-management activities
• Relevant patient experience

For All Applicants: Align the Product and Institution Strategies

Pharmaceutical companies should confirm early that the designated medical institution can satisfy the applicable requirements for governance, personnel, training, ethics oversight and risk management. This is particularly important for products being submitted under the pathway for the first-time, where gaps in institutional readiness could undermine an otherwise strong clinical case.

What the 2026 Guideline Means for GBA Drug Access

The 2026 guideline represents an important evolution of the Hong Kong-Macao drug access pathway. While products entering the scheme for the first-time face more detailed a evidentiary requirements, the revised framework provides a more structured application process and streamlined pathway for eligible products already included in the urgent drug directory.

For companies pursuing accelerated patient access and early patient access and broader China development strategies through the Greater Bay Area, early regulatory planning will become increasingly important. Cisema supports pharmaceutical companies with clinical need assessments, dossier preparation, regulatory strategy and end-to-end support for applications under the GBA Connect Scheme pathway.

Contact Cisema today to discuss your GBA drug access strategy.

Further Information

• Explore Cisema's services for pharmaceutical consulting, covering drug registration (Hong Kong Drug Office) and GBA Connect Scheme Advisory ‍
• Explore Cisema’s services for innovative biotech products, covering cell and gene therapies, CAR-T, monoclonal antibodies, and peptides from early development through post-market compliance

References

• Notice from the Guangdong Provincial Medical Products Administration and Guangdong Provincial Health Commission on Issuing the Application Guide for Imported Hong Kong and Macao Drugs and Medical Devices in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area in Guangdong Province