Combination devices in China are getting more attention from regulatory authorities, China NMPA. Recently RAPS members were asking about the status. Here we provide an overview of one of the guidelines NMPA issued on January 11, 2022, regarding combination product registration, the "Registration Guideline on Combination Products with Devices as Primary Mode of Action" I'd like to share with you some key highlights from the NMPA guideline for combination products. In addition to this guideline, classifications and basic principles are similar to FDA in safety and risks.
Requirements for NMPA Registration
Below lists NMPA submission requirements that are specific for combination product registration:
- Naming and formatting for e-filing submission
- Product description content requirement
- Interactions between medical devices and drugs
- Drug content/dose selection
- Chemical and physical properties
- Biological properties
- Animal study
- Stability study
- Product technical requirements
- Manufacturing information
Key Clinical Points to Consider
The guideline also mentioned the key considerations especially before clinical evaluation and emphasized the main points in clinical trial design of combination products.
Before conducting clinical evaluation, applicants may consider:
- Whether the application scope of device or the drug component when used alone is consistent with or similar to that of the combination product.
- Whether the application scope of the combination product expands or exceeds its original application scope when the components are used alone or claims additional clinical benefits.
- For patients who use the combination product, whether the route of administration, release or drug exposure range would change comparing to the drug being used alone, and whether the change would bring additional risks.
NMPA also recommended applicant to determine the proper clinical evaluation based on risk and benefit of the combination product and suggested some key aspects applicant may consider regarding to clinical trial design.
If you are facing challenges on clinical evaluation submission, pathway determination, and any other questions regarding NMPA registration for combination products, please email me for a further discussion.
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------