In 2019, the Center for Drug Evaluation of China reviewed and approved a total of 8730 drug registration applications. As a follow-up on part 1 of Drug Evaluation Report 2019, part 2 gives an overview of technical review and approval of these registration applications, and an analysis of those approved under each registration classification, including chemical drugs, traditional Chinese medicines and biological products.

From 2015 to 2018, a backlog of drug registration applications was being reviewed and approved by the Center for Drug Evaluation (CDE) reviewers by expanding staff and improving work efficiency. In 2019, CDE further improved the work efficiency to ensure that the registration approvals could be issued for the majority of applications according to the timeline which was stipulated by the National Medical Products Administration (NMPA) of China. More than 90% of applications were reviewed and approved within the timeline, which indicates the achievement of working goals set forth in the Opinions on Reforming the Review & Approval System for Drug and Medical Device Registrations (State Council [2015] No.44, hereinafter referred to as Document No. 44).

CDE reviewed and approved a total of 8730 registration applications in 2019. For each approval type, the number of applications is listed below (Table 1). By the end of 2019, the number of applications which were under or pending for review and approval has dropped from nearly 22,000 at the peak of September 2015 to 4423, indicating the accomplishment of reducing the backlog of registration applications as required by Document No. 44.

For applications under or pending for review and approval, the number of applications under each status is listed in Table 2. For applications with completed technical review, the number of applications under each drug classification is listed in Table 3.

In 2019, CDE completed the technical review for 6817 drug registration applications, among which the number of applications of each application type is shown in the diagram below (Fig. 1) along with the data from 2016 to 2018.

The table below (Table 4) shows the number of applications approved under each registration classification of chemical drugs, including Investigational New Drug (IND), New Drug Application (NDA) and Abbreviated New Drug Application (ANDA). As highlights, 493 applications for Class 1 Innovative New Drug were approved under IND registration while 260 applications for oral solid dosage forms were approved under ANDA.

In 2019, CDE completed the technical review for 5413 chemical drug registration applications, among which the number of applications of each application type is shown in the diagram below (Fig. 2).

Among the chemical drug registration applications, 3412 applications were approved for technical review. For each application type, the number of approvals is listed in Table 5. Under the registration classification New Drug Application (NDA), 88 applications were approved in 2019. For a comparison with the last three years, the numbers of approvals from 2016 to 2019 are shown in the diagram below (Fig. 3).

Others*: herein refers to the applications which were withdrawn by the applicants, pending for material supplement after technical review, submitted to NMPA’s Department of Drug Registration instead of CDE, for drug-device combination registration with NMPA’s Center for Medical Device Evaluation, or withdrawn from the technical review of drug products combined with their related APIs/excipients.

Under the registration classification Investigational New Drug (IND), 599 applications were approved in 2019, among which 493 approvals were under Class 1 Innovative New Drug and covered 189 drug categories. For a comparison with the last three years, the numbers of drug categories where Class 1 IND applications were approved from 2016 to 2019 are shown in the diagram below (Fig. 4). 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.

Among the 189 drug categories, anti-neoplastic, gastrointestinal, anti-infective and nervous system drugs covered 70% of the approvals. The diagram below (Fig. 5) shows the number of drug categories for each indication where Class 1 IND applications were approved in 2019.

In 2019, CDE completed the technical review for 300 traditional Chinese medicine registration applications, among which the number of applications of each application type is shown in the diagram below (Fig. 6).

Among these registration applications, 15 IND applications and 2 NDAs for traditional Chinese medicines were approved for technical review. For each application type, the number of approvals is listed in Table 6. For a comparison with the last three years, the numbers of IND/NDA approvals from 2016 to 2019 are shown in the diagram below (Fig. 7).

The approved traditional Chinese medicine IND registrations covered 10 indications, among which 10 approvals were for cardiovascular, gastrointestinal, anti-neoplastic, respiratory and urological drugs (67% of the total number). The diagram below (Fig. 8) shows the number of approvals for each indication of traditional Chinese medicine IND registrations in 2019.

In 2019, CDE completed the technical review for 1104 biological product registration applications, among which the number of applications of each application type is shown in the diagram below (Fig. 9).

Among these registration applications, 312 IND applications and 74 NDAs for biological products were approved for technical review. For each application type, the number of approvals is listed in Table 7. For a comparison with the last three years, the numbers of IND/NDA approvals from 2016 to 2019 are shown in the diagram below (Fig. 10).

For biological INDs, anti-neoplastic treatment was a hot topic in drug development and covered 50% of the approvals. Meanwhile, half of the biological NDA approvals were for anti-neoplastic and endocrine treatment. The diagrams below (Fig. 11 and 12) show the number of approvals for each indication of biological IND and NDA registrations respectively 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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