In 2019, the Center for Drug Evaluation (CDE) in China approved a large number of registrations for drug products as well as drug-device combinations. The majority of drug registrations required technical review & approval, whereas the others required only administrative approval. The number of different registrations approved by China CDE in 2019 is listed in the table below (Table 1).

The diagram below (Fig. 1) shows a comparison of registration amount among different drug products from 2016 to 2019. Remarkably, 80.2% drug registrations approved in 2019 were for chemical drugs, which had a number of 6475 registrations.

The diagram below (Fig. 2) shows the number of drug registrations approved through technical review from 2016 to 2019. In 2019, a total of 6199 drug registrations were approved through technical review, which shows an increase of 11.21% over last year.

The table below (Table 2) shows the number of drug registrations approved through technical review in 2019. Each drug class is compared with the total drug products in the number of drug registrations in percentage. When comparing with 2018, the registrations of chemical drugs and biological products increased, whereas the registrations of traditional Chinese medicines decreased.

In 2019, there were 700 innovative new drugs approved under registration Class 1, which covered 319 drug categories. The drug category of a chemical drug is referred to as the active pharmaceutical ingredient for the making of that drug, whereas the drug category of a biological product or a traditional Chinese medicine is referred to as the international nonproprietary name (INN) of that drug. The table below (Table 3) shows the number of drug categories of which innovative new drugs were registered in 2019 either for clinical trials (IND) or marketing authorizations (NDA).

In 2019, there were 528 domestic innovative new drugs approved under the drug registration Class 1, which covered 244 drug categories. The table below (Table 4) shows the number of drug registrations as well as categories of domestic innovative new drugs respectively for INDs and NDAs, including chemical drugs and biological products. The indications of these domestic innovative new drugs are mainly cancers, infectious diseases and gastrointestinal disorders.

The table below (Table 5) shows the number of drug registrations as well as categories of imported innovative new drugs and original drugs respectively. The indications of these drugs are mainly cancers, endocrine and neurological disorders.

As shown in Table 2, there were in total 4937 chemical drug registrations approved in 2019. They can be classified according to their application types as INDs, bridging studies, NDAs, ANDAs, supplementary applications, re-registrations of imported drugs, review of re-applications, consistency evaluations and administrative approvals. The diagram below (Fig. 3) shows the number of chemical drug registrations which were approved for all application types in 2019. For new drugs and generics, the number of registrations approved from 2016 to 2019 are shown in another diagram below (Fig. 4) respectively for INDs, bridging studies, NDAs, ANDAs and consistency evaluations.

In 2019, CDE approved 444 IND registrations for domestic chemical drugs and 250 IND registrations for imported chemical drugs. The indications of domestic INDs are mainly cancers, gastrointestinal disorders and infectious diseases, whereas the indications of imported INDs are mainly cancers, infectious diseases and neurological disorders. The diagram below (Fig. 5) shows the number of approved IND registrations for different indications of both domestic and imported chemical drugs in 2019.

In 2019, CDE approved 45 NDA registrations for domestic chemical drugs and 85 NDA registrations for imported chemical drugs. The indications of domestic NDAs are mainly cancers and infectious diseases, whereas the indications of imported NDAs are mainly cancers and neurological disorders. The diagram below (Fig. 6) shows the number of approved NDA registrations for different indications of both domestic and imported chemical drugs in 2019.

In 2019, CDE approved 573 innovative new drug registrations for chemical drugs under registration Class 1, which covered 219 drug categories. The table below (Table 6) shows the number of chemical drug categories of IND and NDA registrations respectively.

The diagram below (Fig. 7) shows the number of approved innovative new drug registrations for domestic and imported chemical drugs respectively from 2016 to 2019.

In 2019, CDE approved 423 traditional Chinese medicine registrations, including 17 IND registrations, 3 NDA registrations and 3 ANDA registrations. The diagram below (Fig. 8) shows the number of traditional Chinese medicine registrations approved for all application types in 2019. For new or generic traditional Chinese medicines, the number of registrations approved from 2016 to 2019 are shown in another diagram below (Fig. 9) respectively for INDs, NDAs and ANDAs.

For innovative new traditional Chinese medicines, 17 IND registrations were approved by CDE in 2019, which were mainly indicated for the treatment of gastrointestinal, respiratory and orthopedic disorders.

In 2019, CDE approved 1179 biological product registrations, including 310 IND registrations and 124 NDA registrations. Furthermore, IND registrations had an increase of 4% over the last year, and NDA registrations had an increase of 45.9%. The diagram below (Fig. 10) shows the number of biological product registrations approved for all application types in 2019. For new or generic biological products, the number of registrations approved from 2016 to 2019 are shown in another diagram below (Fig. 11) respectively for INDs and NDAs (preventative or therapeutic).

In 2019, CDE approved 127 innovative new drug registrations for biological products under registration Class 1, including 2 preventative and 125 therapeutic biological products. The table below (Table 7) shows the number of drug registrations as well as categories of innovative new biological products respectively for INDs and NDAs.

119 therapeutic biological products were approved for IND registrations under registration Class 1. These products covered 95 drug categories and were mainly indicated for the treatment of cancers. The diagram below (Fig. 12) shows the number of approved IND registrations for different indications of therapeutic biological products in 2019.

Accestra Consulting Provides China Regulatory Affairs Outsourcing for Drugs/Pharmaceutical, Food and Feed products for China NMPA (Formerly CFDA) regulatory approval including product registration for China Investigational New Drug (IND), China New Drug Application (NDA), China Drug Master File (DMF) for APIs, Excipient and Packaging Materials, ANDA, eCTD submission and others.

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