The newly released 2021 Drug Review Annual Report by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) data shows that China has achieved doubling of drug approvals in 2021 compared to prior year.
More importantly, it suggests the determination of Chinese authority to encourage more New Drugs to the market by means of facilitating measures in drug review and approval.
In particular, 4 highlights are remarkably noteworthy for those interested in Chinese drug market:
-
- Growing number of approvals,
- Accelerated pathways for drug registration,
- Priority for drugs for specific and urgent uses,
- Innovative new drugs
compiled some of the highlights here below:
- Growing Number of Approvals for Surging Registration Applications
- In 2021, both the number of drug registration applications accepted by CDE and the number of completed approvals have hit record high. The completion rate of on-time review & approval for registration applications has increased to a historical 98.93%.
- For more changes and trends please see China Records Growth in New Drug Application for 2021 (https://www.accestra.com/china-records-growth-in-new-drug-applications-for-2021/)
- Introducing four accelerated pathways for drug registration in China
- Procedure for Breakthrough Therapy Drugs
- In 2021, 263 applications have undergone procedures for breakthrough therapy drugs. 53 of them covering 41 categories were finally approved, targeting multiple indications such as diseases resulted from COVID infections, ovarian cancer, etc.
- Owing to the procedures for breakthrough therapy drugs, 5 New Drugs out of the suggested approved NDAs have expedited their marketing authorization process in 2021.
- Procedure for Conditional Approval
- In 2021, CDE has approved 60 out of 323 suggested approved NDAs and authorized them for marketing with specific conditions, taking up a share of 18.58%.
- Procedure for Priority Review & Approval
- Under the current Drug Registration Regulation, 115 registration applications covering 69 types were included into procedures for priority review & approval in 2021. The detailed distribution as well as a comparison with Year 2020 is as follows:
Drug Categories under Current Drug Registration Regulation
2020
2021
Number of Registration Applications
%
Number of Registration Applications
%
Drugs in clinically urgent need, Innovative drugs and Improved New Drugs for prevention & treatment of major infectious diseases 14 18.67% 5 4.35% New varieties, dosage forms and specifications of pediatric medicines applying to children’s physiological characteristics 7 9.33% 34 29.57% Urgently needed vaccines and innovative vaccines for prevention & control of diseases 4 5.33% 3 2.61% Drugs incorporated into Procedure for breakthrough therapy drugs — — 11 9.57% Drugs applicable to conditional approval 27 36.00% 41 35.65% Drugs under other circumstances stipulated by the NMPA 23 30.67% 21 18.26% Total 75 100% 115 100% - Amongst the registration applications for priority review & approval, 219 drugs (covering 131 varieties) were approved for marketing—with 130 under current Drug Registration Regulation and 89 prior to its promulgation. See the following:
Drug Categories under Current Drug Registration Regulation
Number of Registration Applications
%
Drug Categories prior to Promulgation of Drug Registration Regulation
Number of Registration Applications
%
Drugs in clinically urgent need, Innovative drugs and Improved New Drugs for prevention & treatment of major infectious diseases 9 10.11% New Drugs of obviously clinical value 22 16.92% New varieties, dosage forms and specifications of pediatric medicines applying to children’s physiological characteristics 9 10.11% Synchronous registration application 56 43.08% Urgently needed vaccines and innovative vaccines for prevention & control of diseases 2 2.25% Drugs for rare diseases 13 10.00% Drugs incorporated into Procedure for breakthrough therapy drugs 5 5.62% Pediatric medicine 9 6.92% Drugs applicable to conditional approval 31 34.83% Re-application after improvement by standard of consistency in quality and efficacy with original drugs 16 12.31% Major projects 3 2.31% Drugs under other circumstances stipulated by the NMPA 33 37.08% Expired patents 8 6.15% Drugs in clinically urgent need, Drugs of market shortfall 3 2.31% Total 89 100% Total 130 100%
- Under the current Drug Registration Regulation, 115 registration applications covering 69 types were included into procedures for priority review & approval in 2021. The detailed distribution as well as a comparison with Year 2020 is as follows:
- Procedure for Special Review & Approval
- 81 registration applications were reviewed and approved via procedures for special review & approval in 2021. All of them were either vaccines or treatment medicines for COVID-19.
- Procedure for Breakthrough Therapy Drugs
- Priority to New Drugs with Urgent Need in China
- CDE has continuously invested increasing resources in registration applications for New Drug with urgent clinical needs, Pediatric Medicine, and Drugs for Rare Diseases.
- In the 81 varieties of overseas New Drugs in clinically urgent need, registration applications of 54 varieties were filed, out of which 51 varieties have been authorized for marketing by the end of 2021, bringing new hope for patients suffering from cancer and rare diseases.
- China Approves Innovative New Drugs at Record Highs
- In 2021, CDE accepted 1886 registration applications for innovative drugs (covering 998 varieties), a 76.10% spike year on year, while completing review & approval of 1744 innovative drugs (covering 943 varieties), jumping by 67.85% of last year.
For more detailed information about China’s CDE drug approval or any questions, please contact us at info@accestra.com .
