Current Status and Regulatory Considerations of Drug-led Combination Products
10.13748/j.cnki.issn1007-7693.20231864
- VernacularTitle:以药为主的药械组合产品监管发展现状与思考
- Author:
GE Yuanyuan
1
,
2
;
LIAO Ping
3
;
JIA Guoshu
4
;
LIANG Yan
5
;
ZHANG Jingchen
3
;
CHEN Guiliang
3
;
YUAN Hongmei
1
Author Information
1. 1. Shenyang Pharmaceutical University, Shenyang 110016, China
2. 2. Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China
3. 2. Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China
4. 3. China Pharmaceutical University, Nanjing 211198, China
5. 4. Center for Inspection of Gansu (Center for Vaccine Inspection of Gansu), Lanzhou 730030, China
- Publication Type:Journal Article
- Keywords:
combination products / drug-led / attribute definition / regulatory science
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(20):2774-2785
- CountryChina
- Language:Chinese
-
Abstract:
Abstract: This paper focuses on the regulatory strategy of drug-led drug device combination products, comparing and analyzing the definition, scope and management mode of drug device combination products in the United States, the European Union, Japan, Canada and China; summarizing and analyzing the types of combination products in the Product-specific Guidances for Generic Drug Development(PSGs) of the US FDA's scientific and technical reports in the past five years, the results show that the top three PSGs newly added to the FDA were transdermal system, nasal sprays, and single-dose prefilled syringes/pens(including auto-injectors).
As of March 1, 2023, the National Medical Products Administration(NMPA) had cumulatively announced the results of 339 combination products applied for attribute definition by enterprises, of which 88 were "drug-led drug device combination products", accounting for 26%; and 78 were "device-led drug device combination products", accounting for 23%; the results of "not belonging to drug device combination products" accounted for more than half (51.0%), which indicated that there was a big difference between the industry and the regulatory understanding of the definition of drug-device combination products, and that the existing guideline and documents were unable to provide clear and predictable positioning of the combination products under research and development for the time being.
This paper also puts forward suggestions for solving the problems in the development of drug-device combination products in China, in order to improve the consistency, predictability and transparency of the classification and definition of drug-device combination products in China, and to provide references for the development and scientific supervision of this kind of products.
