Regulatory Open Forum

On September 28, 2023, the China NMPA published a draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis." This release comes just ahead of China's Mid-Autumn Festival and National Day and invites feedback from stakeholders until October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

In addition to the Hainan RWD, China has rich real data across its top hospitals as well. China is a centralized structure. Its top-level III hospitals have thousands of beds, some with 10,000 beds. At the same time, these hospitals have much better interoperability in their HIS systems due to the centralized public hospital structure. 

The Hainan Boao Pilot Zone has introduced a unique initiative that allows overseas medical devices, in-vitro diagnostics (IVDs), and drugs with clinical urgency status to be used in China. Manufacturers can use these unapproved products for commercialization while collecting real-world data (RWD) through Real-World Studies (RWS) conducted in Hainan. This RWD can then be utilized as local clinical evidence in China to support their national NMPA registration approval. As a result, this program has the potential to expedite market access in China, reducing approval times to as little as four months. The "Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port," issued by the Hainan government on March 28, 2023, further reinforces this initiative by not requiring local type testing or significant proof burdens for national approval.

The guideline categorizes real-world study into Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Study, which includes descriptive studies, cohort designs, case-control and derived designs, and the use of real-world data as external controls.

Key considerations for designing real-world study protocols include defining research background and objectives, assessing feasibility, selecting appropriate research designs, creating study flowcharts, defining the study population, assessing device exposure, determining suitable control groups, defining outcome measures, planning data collection, adjusting for confounding variables, establishing follow-up times, and calculating sample size and statistical power.

Moreover, the guideline emphasizes the critical aspect of quality control in real-world study. This includes evaluating data quality, managing bias risks throughout the study process, conducting assessments of bias types, and ensuring compliance with ethical review processes and informed consent regulations.

I'd love to hear your thoughts on your experience in RWD in Hainan. Feel free to email me your feedback before Oct 16, 2023. We can help you submit to China NMPA.

Is the draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis" available in English? T

On September 28, 2023, the China NMPA published a draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis." This release comes just ahead of China's Mid-Autumn Festival and National Day and invites feedback from stakeholders until October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

In addition to the Hainan RWD, China has rich real data across its top hospitals as well. China is a centralized structure. Its top-level III hospitals have thousands of beds, some with 10,000 beds. At the same time, these hospitals have much better interoperability in their HIS systems due to the centralized public hospital structure. 

The Hainan Boao Pilot Zone has introduced a unique initiative that allows overseas medical devices, in-vitro diagnostics (IVDs), and drugs with clinical urgency status to be used in China. Manufacturers can use these unapproved products for commercialization while collecting real-world data (RWD) through Real-World Studies (RWS) conducted in Hainan. This RWD can then be utilized as local clinical evidence in China to support their national NMPA registration approval. As a result, this program has the potential to expedite market access in China, reducing approval times to as little as four months. The "Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port," issued by the Hainan government on March 28, 2023, further reinforces this initiative by not requiring local type testing or significant proof burdens for national approval.

The guideline categorizes real-world study into Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Study, which includes descriptive studies, cohort designs, case-control and derived designs, and the use of real-world data as external controls.

Key considerations for designing real-world study protocols include defining research background and objectives, assessing feasibility, selecting appropriate research designs, creating study flowcharts, defining the study population, assessing device exposure, determining suitable control groups, defining outcome measures, planning data collection, adjusting for confounding variables, establishing follow-up times, and calculating sample size and statistical power.

Moreover, the guideline emphasizes the critical aspect of quality control in real-world study. This includes evaluating data quality, managing bias risks throughout the study process, conducting assessments of bias types, and ensuring compliance with ethical review processes and informed consent regulations.

I'd love to hear your thoughts on your experience in RWD in Hainan. Feel free to email me your feedback before Oct 16, 2023. We can help you submit to China NMPA.

Dan, English version is not available yet.  If you want, we can send you a machine translated English version or the Chinese version.  We recently reviewed 90 FDA approved cases with RWD. Almost 50 cases for premarket clearance.  China NMPA is a little behind in its thinking.  We are trying to work with them to open up more with RWD usage.  Especially China has a lot more centralized harmonized raw patients data that those in the US and EU.   

Is the draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis" available in English? T

On September 28, 2023, the China NMPA published a draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis." This release comes just ahead of China's Mid-Autumn Festival and National Day and invites feedback from stakeholders until October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

In addition to the Hainan RWD, China has rich real data across its top hospitals as well. China is a centralized structure. Its top-level III hospitals have thousands of beds, some with 10,000 beds. At the same time, these hospitals have much better interoperability in their HIS systems due to the centralized public hospital structure. 

The Hainan Boao Pilot Zone has introduced a unique initiative that allows overseas medical devices, in-vitro diagnostics (IVDs), and drugs with clinical urgency status to be used in China. Manufacturers can use these unapproved products for commercialization while collecting real-world data (RWD) through Real-World Studies (RWS) conducted in Hainan. This RWD can then be utilized as local clinical evidence in China to support their national NMPA registration approval. As a result, this program has the potential to expedite market access in China, reducing approval times to as little as four months. The "Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port," issued by the Hainan government on March 28, 2023, further reinforces this initiative by not requiring local type testing or significant proof burdens for national approval.

The guideline categorizes real-world study into Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Study, which includes descriptive studies, cohort designs, case-control and derived designs, and the use of real-world data as external controls.

Key considerations for designing real-world study protocols include defining research background and objectives, assessing feasibility, selecting appropriate research designs, creating study flowcharts, defining the study population, assessing device exposure, determining suitable control groups, defining outcome measures, planning data collection, adjusting for confounding variables, establishing follow-up times, and calculating sample size and statistical power.

Moreover, the guideline emphasizes the critical aspect of quality control in real-world study. This includes evaluating data quality, managing bias risks throughout the study process, conducting assessments of bias types, and ensuring compliance with ethical review processes and informed consent regulations.

I'd love to hear your thoughts on your experience in RWD in Hainan. Feel free to email me your feedback before Oct 16, 2023. We can help you submit to China NMPA.

Grace,

I work in post-market surveillance and I'm interested in the statistical analysis portion. I think a machine translation would be good. Could you send it me at OmbuEnterprises@msn.com?

Dan

Dan, English version is not available yet.  If you want, we can send you a machine translated English version or the Chinese version.  We recently reviewed 90 FDA approved cases with RWD. Almost 50 cases for premarket clearance.  China NMPA is a little behind in its thinking.  We are trying to work with them to open up more with RWD usage.  Especially China has a lot more centralized harmonized raw patients data that those in the US and EU.   

Is the draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis" available in English? T

On September 28, 2023, the China NMPA published a draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis." This release comes just ahead of China's Mid-Autumn Festival and National Day and invites feedback from stakeholders until October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

In addition to the Hainan RWD, China has rich real data across its top hospitals as well. China is a centralized structure. Its top-level III hospitals have thousands of beds, some with 10,000 beds. At the same time, these hospitals have much better interoperability in their HIS systems due to the centralized public hospital structure. 

The Hainan Boao Pilot Zone has introduced a unique initiative that allows overseas medical devices, in-vitro diagnostics (IVDs), and drugs with clinical urgency status to be used in China. Manufacturers can use these unapproved products for commercialization while collecting real-world data (RWD) through Real-World Studies (RWS) conducted in Hainan. This RWD can then be utilized as local clinical evidence in China to support their national NMPA registration approval. As a result, this program has the potential to expedite market access in China, reducing approval times to as little as four months. The "Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port," issued by the Hainan government on March 28, 2023, further reinforces this initiative by not requiring local type testing or significant proof burdens for national approval.

The guideline categorizes real-world study into Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Study, which includes descriptive studies, cohort designs, case-control and derived designs, and the use of real-world data as external controls.

Key considerations for designing real-world study protocols include defining research background and objectives, assessing feasibility, selecting appropriate research designs, creating study flowcharts, defining the study population, assessing device exposure, determining suitable control groups, defining outcome measures, planning data collection, adjusting for confounding variables, establishing follow-up times, and calculating sample size and statistical power.

Moreover, the guideline emphasizes the critical aspect of quality control in real-world study. This includes evaluating data quality, managing bias risks throughout the study process, conducting assessments of bias types, and ensuring compliance with ethical review processes and informed consent regulations.

I'd love to hear your thoughts on your experience in RWD in Hainan. Feel free to email me your feedback before Oct 16, 2023. We can help you submit to China NMPA.

Hi Dan,

Please find the Chinese and the machine translated English copies attached.

Grace.

Grace,

I work in post-market surveillance and I'm interested in the statistical analysis portion. I think a machine translation would be good. Could you send it me at OmbuEnterprises@msn.com?

Dan

Dan, English version is not available yet.  If you want, we can send you a machine translated English version or the Chinese version.  We recently reviewed 90 FDA approved cases with RWD. Almost 50 cases for premarket clearance.  China NMPA is a little behind in its thinking.  We are trying to work with them to open up more with RWD usage.  Especially China has a lot more centralized harmonized raw patients data that those in the US and EU.   

Is the draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis" available in English? T

On September 28, 2023, the China NMPA published a draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis." This release comes just ahead of China's Mid-Autumn Festival and National Day and invites feedback from stakeholders until October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

In addition to the Hainan RWD, China has rich real data across its top hospitals as well. China is a centralized structure. Its top-level III hospitals have thousands of beds, some with 10,000 beds. At the same time, these hospitals have much better interoperability in their HIS systems due to the centralized public hospital structure. 

The Hainan Boao Pilot Zone has introduced a unique initiative that allows overseas medical devices, in-vitro diagnostics (IVDs), and drugs with clinical urgency status to be used in China. Manufacturers can use these unapproved products for commercialization while collecting real-world data (RWD) through Real-World Studies (RWS) conducted in Hainan. This RWD can then be utilized as local clinical evidence in China to support their national NMPA registration approval. As a result, this program has the potential to expedite market access in China, reducing approval times to as little as four months. The "Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port," issued by the Hainan government on March 28, 2023, further reinforces this initiative by not requiring local type testing or significant proof burdens for national approval.

The guideline categorizes real-world study into Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Study, which includes descriptive studies, cohort designs, case-control and derived designs, and the use of real-world data as external controls.

Key considerations for designing real-world study protocols include defining research background and objectives, assessing feasibility, selecting appropriate research designs, creating study flowcharts, defining the study population, assessing device exposure, determining suitable control groups, defining outcome measures, planning data collection, adjusting for confounding variables, establishing follow-up times, and calculating sample size and statistical power.

Moreover, the guideline emphasizes the critical aspect of quality control in real-world study. This includes evaluating data quality, managing bias risks throughout the study process, conducting assessments of bias types, and ensuring compliance with ethical review processes and informed consent regulations.

I'd love to hear your thoughts on your experience in RWD in Hainan. Feel free to email me your feedback before Oct 16, 2023. We can help you submit to China NMPA.

Grace,

Thank you for the documents. I look forward to studying them.

Regards,

Dan

Hi Dan,

Please find the Chinese and the machine translated English copies attached.

Grace.

Grace,

I work in post-market surveillance and I'm interested in the statistical analysis portion. I think a machine translation would be good. Could you send it me at OmbuEnterprises@msn.com?

Dan

Dan, English version is not available yet.  If you want, we can send you a machine translated English version or the Chinese version.  We recently reviewed 90 FDA approved cases with RWD. Almost 50 cases for premarket clearance.  China NMPA is a little behind in its thinking.  We are trying to work with them to open up more with RWD usage.  Especially China has a lot more centralized harmonized raw patients data that those in the US and EU.   

Is the draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis" available in English? T

On September 28, 2023, the China NMPA published a draft guideline "Guideline on Medical Device Real-world Study Design and Statistical Analysis." This release comes just ahead of China's Mid-Autumn Festival and National Day and invites feedback from stakeholders until October 16, 2023. The proposed guideline will facilitate overseas manufacturers to further explore the Hainan Real-world Data pilot program.

In addition to the Hainan RWD, China has rich real data across its top hospitals as well. China is a centralized structure. Its top-level III hospitals have thousands of beds, some with 10,000 beds. At the same time, these hospitals have much better interoperability in their HIS systems due to the centralized public hospital structure. 

The Hainan Boao Pilot Zone has introduced a unique initiative that allows overseas medical devices, in-vitro diagnostics (IVDs), and drugs with clinical urgency status to be used in China. Manufacturers can use these unapproved products for commercialization while collecting real-world data (RWD) through Real-World Studies (RWS) conducted in Hainan. This RWD can then be utilized as local clinical evidence in China to support their national NMPA registration approval. As a result, this program has the potential to expedite market access in China, reducing approval times to as little as four months. The "Regulations on the Administration of Urgent Use Imported Drugs and Medical Devices in the Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port," issued by the Hainan government on March 28, 2023, further reinforces this initiative by not requiring local type testing or significant proof burdens for national approval.

The guideline categorizes real-world study into Pragmatic Randomized Controlled Trials (pRCTs) and Observational Real-World Study, which includes descriptive studies, cohort designs, case-control and derived designs, and the use of real-world data as external controls.

Key considerations for designing real-world study protocols include defining research background and objectives, assessing feasibility, selecting appropriate research designs, creating study flowcharts, defining the study population, assessing device exposure, determining suitable control groups, defining outcome measures, planning data collection, adjusting for confounding variables, establishing follow-up times, and calculating sample size and statistical power.

Moreover, the guideline emphasizes the critical aspect of quality control in real-world study. This includes evaluating data quality, managing bias risks throughout the study process, conducting assessments of bias types, and ensuring compliance with ethical review processes and informed consent regulations.

I'd love to hear your thoughts on your experience in RWD in Hainan. Feel free to email me your feedback before Oct 16, 2023. We can help you submit to China NMPA.