China Drug Evaluation Report 2019 by CDE – Part 2. Drug Registration Review & Approval

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.

Table 1. Number of applications reviewed and approved in 2019.

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.

Table 2. Number of applications under or pending review and approval in 2019.

Table 3. Number of applications with completed technical review of 2019.

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.

Table 4. Number of applications approved under each chemical drug registration classification.

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).

Table 5. Overview of approvals for Chemical Drug Registrations in 2019.

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).

Table 6. Overview of approval for Traditional Chinese Medicine registrations in 2019.

The approved traditional Chinese medicine IND registrations covered 10 indications, among which 10 approvals were for:

• cardiovascular,
• gastrointestinal,
• anti-neoplastic,
• respiratory,
• 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).

Table 7. Overview of approvals for Biological Product REgistrations in 2019.

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.

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