Pathways’ Pick of the Week: China Clarifies Combination Products Rules

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The National Medical Products Administration updated its policies and issued a draft guidance on designation and submissions of single-entity drug-device combination products. Importantly, NMPA made its submission requirements more flexible. Excerpted from Pathways’ Picks July 27.

China has a country-of-origin requirement for combination products, under which premarket certification granted by the country where the product is made must be submitted to NMPA in its registration application. Up until late July, NMPA also required sponsors to include a separate country-of-origin, or Chinese, medicine certification for the drug component. But that policy has blocked combo products from China’s market in cases where the drug component is not sold as a standalone product or is not regulated on its own as a drug elsewhere. The new policy removes the requirement for individual drug certification documents to be submitted in cases where the components have not been separately approved in China or the country of origin.

In addition, NMPA clarified it procedures for determining whether the device or drug center should take the review lead for a product based on its primary mode of action. In China, similar to US FDA policies, a manufacturer should initially assess which component plays the principal role in the product’s action to determine the lead center. If it is not clear, the company must submit to NMPA for a designation decision. The updated policy specifies that companies must seek this “attribute” decision from the Medical Device Standards Management Center and sets new submission requirements and timelines for the process. NMPA also emphasizes the need for the device and drug review centers to coordinate efforts, and for the lead center to forward materials to the other when a joint review is necessary.

Also, NMPA issued a draft guidance describing general clinical evaluation, animal testing, and other expectations for registration filing applications for drug-device combo products. Public comments on the draft are due August 20. (Links in Simplified Chinese.)

Excerpted from “Pathways Picks July 27: Combo Product Policies, EU Updates, and More to Watch,” Market Pathways, July 27, 2021.


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