NMPA Gives Full Support To China Real World Data Application Pilot Projects
2022-04-27
On April 22, 2022, NMPA published a Communication Procedure for Medical Device Real World Data Application Projects in Hainan Boao Lecheng Medical Tourism Pilot Zone. As per this Procedure, NMPA will enhance the guide on medical device pilot program in Hainan to help apply RWD for China registration.
Hainan Medical Tourism Pilot Zone
Urgent Use Policy & RWD
The foreign-approved medical devices, IVDs and drugs for urgent Chinese clinical needs, without predicates approved in China, can be imported to Hainan via the policy dated back to April 2018.
The real-world data generated in the Hainan pilot zone can support the registration with NMPA.
What Products are Qualified ?
NMPA unapproved products
No predicates or better than predicates in China
Clinically significant
Benefits:
Expanded scope of overseas imported medical devices allowed to enter the Pilot Zone; Imported and inventoried products in Hainan are considered duty-free.
Greater access to urgently needed medical devices entering Hainan via the emergency review pathways, and devices can be stored in bonded warehouses in Pilot Zones before approval is obtained; and
More leeway given to enterprises to collect and apply real-world clinical data for medical devices, to expedite approval processes and shorten time of marketing.
The urgent use approved products by Hainan can be promoted outside of Hainan throughout China. Patients can come from anywhere in China. However, treatments need to be done in Hainan, but follow-up can be done outside of Hainan.
Generating revenue immediately while collecting Real-World data (RWD). Products can be sold directly to hospitals from overseas manufacturers.
Hainan Pilot Zone Benefits: Commercial & Regulatory
NMPA un-approved devices but with major country-of-origin approval can be used and sold in real clinical setting
No local type testing required before commercial use
Save money and time for national NMPA regulatory approval
Revenue generating clinical data can be used as real-world evidence (RWE) to support China NMPA regulatory approval
Duty free with local warehouse
Overseas clinicians can practice and perform surgeries
Real World Data Application
providing clinical evidence for the CER based on equivalence route;
supporting product registration by using the real-world data generated after special approval of clinically urgently needed foreign medical devices;
as the external control for a single arm study;
providing clinical data for the establishment of the objective performance criteria for a single arm study;
supporting an amendment to existing medical device registration in terms of scope of application, intended use, and contraindications;
supporting an amendment to the clinical values claimed in IFU;
supporting post-market studies on products with a conditional approval;
for use in the evaluation of long-term safety and effectiveness of high-risk implants;
for use in the clinical evaluation of medical devices for treatment of rare diseases throughout the full life cycle to expedite the product registration; and
post-market surveillance.
NOTE: Currently, real world data cannot be used as sole clinical evidence; however, it can be used to support product registration as a supplement to existing evidence.
Hainan Real World Study Program (RWD Pilot Program → Fast Track Program)
October, 2019, 1st batch of clinical real-world data application research products (Fast Track Program) granted
3 medical device products (2 devices have been approved)
December, 2020, 2nd batch of clinical real-world data application research products (Fast Track Program) granted
3 drug products (1 drug has been approved)
11 medical device products of 9 manufacturers (1 medical device has been approved)
NMPA Approval Examples with RWD
Boston Scientific
Dec, 2020: Approved as 2nd batch of RWD application pilot (Fast Track)
Oct, 2021: Submitted RWD with overseas clinical trial data for registration
Mar, 2022: Approved with NMPA registration certificate
Notes:
RWD plays a role of supplementary clinical evidence for China registration, rather than solo clinical evidence
RWD should be combined with overseas clinical trial data or clinical evaluation with comparison to predicate
BradyKnows is managing eight real world studies now in Hainan to help overseas manufactures use RWD for supporting China registration. Pls feel free to reach out to us for any questions in China RWD via info@bradyknowsmedical.com
