Defining matters related to the registration of pharmaceutical and pharmaceutical products

In order to strengthen the registration management of pharmaceutical and pharmaceutical products, according to the relevant regulations on the registration management of pharmaceuticals and medical devices, the State Food and Drug Administration issued a notice to the composition, declaration and registration of pharmaceutical and pharmaceutical products, and the registration and acceptance departments. Clear. The notice shall be implemented as of the date of promulgation, and the Notice on Issues Concerning the Registration and Management of Products Combined with Drugs and Medical Devices (National Food and Drug Administration [2004] No. 94) shall be abolished at the same time.

Notice on matters relating to the registration of pharmaceutical and pharmaceutical products

In order to strengthen the registration management of pharmaceutical and pharmaceutical products, according to the relevant regulations on the registration management of pharmaceuticals and medical devices, the relevant matters concerning the registration of pharmaceutical and pharmaceutical products are as follows:

1. A medical device combination product is a product that is composed of a drug and a medical device and is produced as a single entity.

Second, the drug-medicine combination products based on the role of drugs, need to declare drug registration; medical equipment combined products based on the role of medical devices, need to declare medical device registration.

3. The pharmaceutical and medical combination products to be declared for registration. If such products have not been approved for listing in China, the applicant shall apply to the Administrative Acceptance Service Center of the State Food and Drug Administration for the definition of product attributes before submitting the application for registration. Instructions for registration of drugs or medical devices and related supporting materials.

4. The Administrative Acceptance Service Center of the State Food and Drug Administration, together with the Drug Evaluation Center and the Medical Device Technology Evaluation Center, shall form an expert group for the evaluation of the attributes of the drug and medical combination products, and shall be responsible for verifying the attributes of the drug and medical combination products as pharmaceutical or medical device declarations. Within 20 working days from the date of application, the opinions on the definition of the property shall be submitted and the applicant shall be notified in writing.

5. The applicant shall submit an application for registration of a drug or medical device to the State Food and Drug Administration according to the product property evaluation opinions, and indicate the “pharmaceutical combination product” in the application form.

6. The first imported medical and medical combination products, which have not been approved for export by the exporting country (region), and the drugs contained in the medical equipment combination products have not been registered in China or have not been approved by the producing country (region), will not be accepted.

7. The Drug Evaluation Center of the State Food and Drug Administration and the Medical Device Technology Evaluation Center establish a coordination mechanism. The drug and medical combination products registered in accordance with the drug declaration shall be reviewed by the drug evaluation center. If a joint review is required, the medical device part of the registration application materials shall be forwarded to the medical device technical evaluation center for simultaneous review; the medical device registered according to the medical device registration The combined products shall be reviewed by the Medical Device Technical Evaluation Center. If a joint review is required, the drug part of the registration application materials shall be forwarded to the Drug Evaluation Center for simultaneous review. The two sides completed the review work separately, and issued the conclusions of the review. The lead units will summarize and make an overall evaluation. After issuing the conclusions of the review, they will be transferred to the corresponding business department of the State Food and Drug Administration for administrative approval.

8. Drug-coated stents, catheters with antibacterial coatings, drug-containing condoms, medicated birth control rings, etc., registered and managed according to medical devices, wound-sticks containing antibacterial and anti-inflammatory drugs, and topical products for external use of traditional Chinese medicines Wait for registration by drug.

IX. This Notice shall be implemented as of the date of promulgation. The Notice on Issues Concerning the Registration and Management of Drugs and Medical Devices Combined Products (National Food and Drug Administration [2004] No. 94) shall be abolished at the same time.