GBA Connect Scheme: Using Real World Data to Support China NMPA Approval

Real World Data (RWD) collected through the GBA Connect Scheme can be transformed into standard clinical evidence for the National Medical Products Administration (NMPA) registration approval process, enabling products to be marketed across all provinces and regions in China. This approach accelerates approval timelines and ensures the safety and efficacy of medical products in real-world settings.

As of March 2024, the GBA Connect Scheme has approved 59 urgently needed imported medical products from Hong Kong and Macau, benefiting over 5,000 patients. The impact is significantly growing, and the increasing maturity of the RWD collection and analysis process in the GBA is evident. Read more about the progress of approvals through our blog post on the GBA Connect Scheme.

Continue below for the full guide or get in touch with Cisema for regulatory consulting on GBA Connect Scheme and China NMPA registration.

Recent Developments: Harnessing GBA Real World Data for Better Healthcare

The collection and analysis of RWD in the China GBA allow NMPA reviewers to understand how medical products perform outside of controlled trial environments. This data offers insights into product safety, effectiveness, and potential benefits, which are essential for informed regulatory decisions.

Two recent announcements by the Guangdong MPA illustrate the potential of the GBA Connect Scheme to drive advanced medical research through RWD:

Lemborexant Real World Study for Insomnia in China

On April 12, 2024, the Guangdong MPA highlighted a pioneering Real World Study (RWS) conducted on Lemborexant, targeting insomnia treatment in Chinese patients.

This study, the first domestic RWS for Lemborexant in China, was led by the Guangdong Provincial People's Hospital and the Nanfang Hospital of Southern Medical University. By focusing on patient-reported outcomes, the research aims to collect comprehensive data on the drug's efficacy and safety, enhancing clinical understanding and supporting regulatory processes.

Brolucizumab Real World Study for Diabetic Macular Edema

On June 6, 2024, another case study was shared by the Guangdong MPA. The Guangdong Provincial People's Hospital has launched a pioneering RWS to evaluate the use of Brolucizumab in treating refractory diabetic macular edema. This study, the first of its kind in China for Brolucizumab, aims to assess the drug's effectiveness and safety in a real-world clinical setting. The findings provide valuable insights into the drug's performance, potentially influencing broader clinical practices and regulatory decisions.

These real-world studies for GBA-approved products align with the Technical Review Guidelines for Real-World Evidence Supporting Drug Development released by the NMPA in 2020. These guidelines provide a fundamental framework for conducting real-world research, promoting drug development, evaluation, and regulation in China.

Why GBA Real World Data Matters for Overseas Manufacturers

Understanding the strategic value of GBA RWD helps manufacturers determine whether this pathway aligns with their China market entry plans.

Accelerated Market Access Through Early Clinical Use

The GBA Connect Scheme allows early introduction of medical products into designated institutions, facilitating RWD collection before nationwide approval and expediting NMPA processes.

Broader and More Representative Clinical Insights

RWD encompasses diverse patient populations, offering broader insights into product benefits and risks compared to traditional clinical trials. This inclusivity supports informed clinical and regulatory decisions.

Reduced Time and Cost Burden

Conducting RWD studies in the GBA reduces the time and financial burden associated with extensive clinical trials required for NMPA approval. The data collected can serve as supplementary evidence, potentially expediting product launches and improving patient access.

Improved Patient Outcomes

By leveraging the GBA Connect Scheme, medical products reach patients in need more quickly, offering access to advanced treatments that are not yet available in the broader mainland market. This approach improves patient care but also provides invaluable data that can inform future medical advancements.

How GBA Real World Data Accelerates Approval Timelines in China

GBA RWD contributes to faster approvals through several interlinked mechanisms that reshape the traditional evidence pathway.

Policy Supporting Early Data Collection

The GBA Connect Scheme allows for the early introduction and usage of medical products in designated institutions within the GBA before nationwide approval. This early usage, facilitated by policy support, generates valuable Real World Data on the product’s performance, helping to accelerate the data collection and approval process for NMPA registration.

Streamlined Review Process

The NMPA uses the RWD to complement traditional clinical trial data. This dual approach provides a more comprehensive evidence base, which can expedite the regulatory review process.

Timeframes

While traditional clinical trials can take several years, the integration of RWD can shorten this period significantly. The time from initial data collection to regulatory submission may be reduced up to 50% of time required for traditional approval pathways, depending on the robustness of the RWD and the efficiency of the review process.

Final Thoughts on GBA Real World Data and China Market Strategy

Since the official launch of the GBA Connect Scheme in 2021, overseas manufacturers have utilized their marketing approvals in Hong Kong to effectively distribute pharmaceuticals and medical devices to designated medical institutions in the GBA. The GBA Connect Scheme is expected to expand its coverage across more product categories, reinforcing its role as a hub for impactful real-world research and supporting broader healthcare innovation.  By focusing on RWD, manufacturers can gain comprehensive clinical insights, expedite regulatory approvals, and ultimately enhance patient outcomes. 

For further details, explore Cisema’s advisory services covering drug registration and medical device listing in Hong Kong, as well as GBA Connect Scheme regulatory support. Get in touch today to navigate your path to regulatory approval and expedite market entry in China.

Further Information

• Drug Registration (Hong Kong Drug Office) and GBA Connect Scheme Advisory
• Medical Device Listing (Hong Kong, MDACS) and GBA Connect Scheme Advisory

References

Guangdong Provincial Medical Products Administration

• Another “Hong Kong and Macao Pharmaceutical and Medical Device Connect” Innovative Drug Launches a Real-World Study (Chinese)
  Read the official announcement
• Guangdong MPA Supports Real-World Research Under the “Hong Kong and Macao Pharmaceutical and Medical Device Connect” Scheme (Chinese)
  Read the Guangdong MPA media release

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About the Author: Jacky Li

Jacky Li is a Senior Manager at Cisema, based in Hong Kong and Taiwan. He has over a decade of experience in regulatory intelligence and market access, and serves as the lead supporting clients across Hong Kong, Mainland China (including the Greater Bay Area), and Taiwan, with a strong focus on pharmaceutical and medical device regulatory projects.

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