New Chemical Drug/Biological Product Registration Classification

On June 30, the State Food and Drug Administration issued a notice on the requirements for registration classification and declaration information of biological products (No. 43 in 2020), and a notice on the requirements for registration classification and declaration information of chemical drugs (No. 44 in 2020). The registration and classification of chemicals and biological products will be implemented from July 1, 2020. The requirements for the registration and application materials for chemical drugs and biological products will be implemented from October 1, 2020. Before September 30, 2020, the application materials can be submitted according to the original requirements.

The chemical drug registration classification has not changed much compared with the 2016 version. The classification of chemical drug registration is divided into 5 categories, namely: innovative drugs that are not listed at home and abroad (category 1), improved new drugs that are not listed at home and abroad (category 2), and domestic applicants imitating overseas listing but not listed in the original research Pharmaceutical drugs (category 3), domestic applicants imitating drugs already listed in the domestic market for original drugs (category 4), and overseas drug applications for domestic market (category 5). Compared with the 2016 version, the new version only refines keywords and some terms. The main changes are: 1. "APIs and preparations", "preparations" are changed to "drugs"; the definition of category 2, 3 and 4 medicines emphasizes consistency evaluation; 3, 5.1 classification adds improved New drugs and new indications for domestically-listed overseas original research drugs are declared and listed in China.

Biological product registration classification: The unified classification rules of the three types of biological products are concise and clear. Biological products are divided into three categories: preventive biological products, therapeutic biological products, and in vitro diagnostic reagents managed by biological products. The classification of the three types of biological products is based on the degree of innovation and the rules of domestic and foreign listing, which is concise and clear. Preventive biological products are divided into innovative vaccines (category 1), improved vaccines (category 2), and vaccines that have been marketed in China or abroad (category 3).There are detailed types under each classification; therapeutic biological products are divided into Innovative biological products (category 1), improved biological products (category 2), and domestic or overseas biological products (category 3), each of which has a detailed type below; according to the in vitro diagnostic reagents managed by biological products Innovative in vitro diagnostic reagents (category 1), in vitro diagnostic reagents already on the market at home and abroad (category 2).

Refine drug registration classifications and encourage innovation across the board. Drug registration classification is an important indicator for positioning a drug, and it has an impact on various aspects of drug clinical trials, declaration, pricing, and access. In the context of the state encouraging innovation, Class 1 innovative drugs can receive priority review treatment, have higher independent pricing power, and have smooth access channels. In contrast, the 4 generic drugs with many competitive products have less preferential treatment. Therefore, accurate classification of drugs is an important prerequisite for drug management. In the context of medical insurance control costs, the strategy of changing cages and birds requires that the costs of generic and auxiliary drugs with low innovation and full competition be reduced as much as possible, in exchange for more innovative drugs and clinically needed drugs to enter medical insurance. The new version of drug registration classification more strictly follows the standard of classification based on the degree of innovation. Combined with the new version of "Drug Registration Management Measures" and "Drug Production Supervision and Management Measures", drugs with a high degree of innovation can enjoy corresponding preferential treatment.