Review time of oncology drugs and its underlying factors: an exploration in China
Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We included all new oncology drug applications submi...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-11-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2023.1151784/full |
| _version_ | 1797643394682454016 |
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| author | Xingyue Zhu Bao Liu |
| author_facet | Xingyue Zhu Bao Liu |
| author_sort | Xingyue Zhu |
| collection | DOAJ |
| description | Introduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We included all new oncology drug applications submitted to China’s National Medical Product Administration (NMPA) between 1 January 2018 and 31 December 2021, and ultimately succeeded in achieving marketing approval. For each drug, the length of the NMPA review process and other major characteristics were collected, including the registration class, approval class, priority review designation, and launch delay relative to the United States, as well as the number of patients enrolled, comparator, and primary endpoint of the pivotal trials supporting the approval. Linear regression model was employed to analyze the effects of factors of interest on the NMPA review time.Results: From 2018 to 2021, NMPA received 137 oncology applications that were ultimately approved. Half of the approvals [76 (55.5%)] were first licensed in the US, leaving a median launch delay of 2.71 years (IQR, 1.03–5.59) in China. In the pivotal studies, the median enrollment was 361 participants (IQR, 131–682), and the use of control groups [90 (65.7%)] and surrogate endpoints [101 (73.7%)] was prevalent. The median review time was 304 days (IQR, 253–376). Multivariate analysis for log-transformed review time showed that larger enrollment (> 92) was associated with a drop of 20.55% in review time (coefficient = −0.230; 95% CI, −0.404 to −0.055; p = 0.010); and a short delay (0 < delay ≤ 1.95 years) was associated with a drop of 17.63% in review time (coefficient = −0.194; 95% CI, −0.325 to −0.062; p = 0.004).Discussion: The short launch delay relative to the US was one important driver to the review speed of NMPA, which might suggest its latent regulatory reliance on the other global regulator during the post-marketing period when new information on the drug’s clinical benefit was still lacking. |
| first_indexed | 2024-03-11T14:14:09Z |
| format | Article |
| id | doaj.art-5ccc3192a3f64445b833d17f2f1a325e |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-03-11T14:14:09Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pharmacology |
| spelling | doaj.art-5ccc3192a3f64445b833d17f2f1a325e2023-11-01T11:04:40ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122023-11-011410.3389/fphar.2023.11517841151784Review time of oncology drugs and its underlying factors: an exploration in ChinaXingyue Zhu0Bao Liu1Department of Pharmacy Administration, School of Medicine and Health Management, Guizhou Medical University, Guiyang, ChinaDepartment of Health Economics, School of Public Health, Fudan University, Shanghai, ChinaIntroduction: How the launch delay of drugs and other factors of interest can influence the length of the review period by drug agencies is still unknown, and understanding this can help better strike the trade-off related to review speed.Methods: We included all new oncology drug applications submitted to China’s National Medical Product Administration (NMPA) between 1 January 2018 and 31 December 2021, and ultimately succeeded in achieving marketing approval. For each drug, the length of the NMPA review process and other major characteristics were collected, including the registration class, approval class, priority review designation, and launch delay relative to the United States, as well as the number of patients enrolled, comparator, and primary endpoint of the pivotal trials supporting the approval. Linear regression model was employed to analyze the effects of factors of interest on the NMPA review time.Results: From 2018 to 2021, NMPA received 137 oncology applications that were ultimately approved. Half of the approvals [76 (55.5%)] were first licensed in the US, leaving a median launch delay of 2.71 years (IQR, 1.03–5.59) in China. In the pivotal studies, the median enrollment was 361 participants (IQR, 131–682), and the use of control groups [90 (65.7%)] and surrogate endpoints [101 (73.7%)] was prevalent. The median review time was 304 days (IQR, 253–376). Multivariate analysis for log-transformed review time showed that larger enrollment (> 92) was associated with a drop of 20.55% in review time (coefficient = −0.230; 95% CI, −0.404 to −0.055; p = 0.010); and a short delay (0 < delay ≤ 1.95 years) was associated with a drop of 17.63% in review time (coefficient = −0.194; 95% CI, −0.325 to −0.062; p = 0.004).Discussion: The short launch delay relative to the US was one important driver to the review speed of NMPA, which might suggest its latent regulatory reliance on the other global regulator during the post-marketing period when new information on the drug’s clinical benefit was still lacking.https://www.frontiersin.org/articles/10.3389/fphar.2023.1151784/fulldrug lagreview durationdrug approvalinformation vacuum periodquality of evidence |
| spellingShingle | Xingyue Zhu Bao Liu Review time of oncology drugs and its underlying factors: an exploration in China Frontiers in Pharmacology drug lag review duration drug approval information vacuum period quality of evidence |
| title | Review time of oncology drugs and its underlying factors: an exploration in China |
| title_full | Review time of oncology drugs and its underlying factors: an exploration in China |
| title_fullStr | Review time of oncology drugs and its underlying factors: an exploration in China |
| title_full_unstemmed | Review time of oncology drugs and its underlying factors: an exploration in China |
| title_short | Review time of oncology drugs and its underlying factors: an exploration in China |
| title_sort | review time of oncology drugs and its underlying factors an exploration in china |
| topic | drug lag review duration drug approval information vacuum period quality of evidence |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2023.1151784/full |
| work_keys_str_mv | AT xingyuezhu reviewtimeofoncologydrugsanditsunderlyingfactorsanexplorationinchina AT baoliu reviewtimeofoncologydrugsanditsunderlyingfactorsanexplorationinchina |