Recently, the State Food and Drug Administration issued the newly revised "Notice on Matters Concerning the Registration of Combination Products of Medicines and Devices" (No. 52 of 2021, hereinafter referred to as Circular No. 52). The background and main revisions of the announcement of Circular 52 are as follows:

 

1. Revised background

 

With the rapid development of the pharmaceutical industry, as well as the revision and implementation of the "Drug Administration Law", "Regulations on the Supervision and Administration of Medical Devices" and supporting regulations, the "Notice on Matters Concerning the Registration of Medicine and Device Combination Products" (formerly the State Food and Drug Administration Announcement 2009 No. 16, hereinafter referred to as Circular No. 16) can no longer fully meet the needs of current laws, regulations and industry development. The more prominent issues are as follows:

 

　　 One is the inapplicability of product listing certification requirements. According to Announcement No. 16, when applying for registration of an imported drug-device combination product, in addition to submitting a certification of the combination product's marketing in the country of origin, it is also necessary to submit a certification of the drug's part in the country of origin or my country. In actual work, some imported medicine and device combination products contain pharmacologically effective ingredients that are not subject to drug management or are only developed for combination products in foreign countries, and it is impossible to provide the country of origin drug marketing certificate; and the combination products often use raw materials and dosages during production. , Mode of action, etc. are different from independently marketed drugs. Therefore, some pharmaceutical and device combination products listed overseas cannot be registered in my country.

 

　　 The second is the change in the work procedures for defining the attributes of drug-device combination products. Announcement No. 16 clarifies that the Acceptance Center, in conjunction with the Drug Evaluation Center and the Device Evaluation Center, is responsible for defining the attributes of drug-device combination products, and stipulates the time limit for the attribute definition work; and the "Notice on Adjusting the Attribute Definition of Drug-Device Combination Products" issued in 2019 (National Drug The Supervision Administration Notice No. 28 of 2019, hereinafter referred to as Notice No. 28), adjusted the attribute definition functional department of drug-device combination products to the standard management center, and further clarified the attribute definition process, time limit, work requirements and application data requirements, etc. .

 

Therefore, in order to adapt to changes in laws and regulations and the needs of industry development, it is urgent to amend Circular 16.

 

2. Explanation of the main contents of the revision

 

(1) Adjusted the relevant requirements of the drug-device combination product listing certificate

 

In Circular 52, Article 6 of Circular 16 requires that drugs contained in imported drug-device combination products need to be separately registered in China or approved for marketing by the country of production (region), and the content of Article 2 is integrated, and the role of drugs is clearly defined. The main drug-device combination products shall be applied for registration in accordance with the relevant requirements of drugs; the drug-device combination products that focus on the role of medical devices shall be applied for registration in accordance with the relevant requirements of medical devices, and the requirements of the corresponding regulatory categories for the country of origin listing certification documents shall be implemented; for the drug-device combination If the drug or medical device contained in the product has been approved for marketing in China or the country of production (region), the corresponding marketing certification documents should be submitted when applying for the registration of the drug-device combination product to further support the safety and effectiveness of the product; If the medicines or medical devices contained in the drug-device combination product have not been separately approved for marketing in China or the country of production (region), the marketing and sales certification documents of the contained drugs or medical devices are not required when applying for the registration of the drug-device combination product.

 

(2) Revise the relevant content of the attribute definition of the combination product of medicine and equipment

 

In view of the adjustment of the functional departments, process, time limit, work requirements, and application materials requirements for the attribute definition of drug-device combination products, the corresponding contents of Articles 3 and 4 of Circular 52 have been revised. As Article 8 of Circular 28 clearly states that "other matters related to the registration of drug-device combination products shall be implemented in accordance with the "Notice on Registration of Drug-Device Combination Products" (State Food and Drug Administration Announcement No. 16, 2009)", Circular 28 The relevant content has been adjusted to Announcements 1 and 2 of Circular 52, and further clarified the time limit for the Standardization Management Center to accept applications and reexamination for the attribute definition of drug-device combination products, as well as the meaning of the "primary mode of action". Announcement No. 28 shall be repealed at the same time.

 

For the drug-device combination product to be registered, if the applicant cannot determine its management attributes, it should apply to the Standards Management Center for the definition of the drug-device combination product attributes before applying for registration; for example, refer to previously registered drug-device combination products or published drug-device combination products If the result of attribute definition can determine the management attributes of the product, it can apply for registration in accordance with the determined management attributes.

 

Considering that the examples of drug-device combination product attributes cannot be exhaustively listed, the relevant content of the examples of drug-device combination product management attributes has been deleted and amended to "If there are clear management attribute provisions in relevant regulations and documents, they shall be implemented in accordance with their regulations."

 

3.Other

 

In the actual application of the product, there are cases where pharmacologically active ingredients are combined with medical devices. Such active ingredients are usually not used alone or are only developed for combined products, and no separate drug marketing certificate can be obtained. Regardless of whether such active ingredients are included in the pharmacopoeia, their combination with a medical device as a single entity is deemed to meet the definition of a drug-device combination product.