Discrepancies Persist in Generic Drug Approval Data Despite Regulator’s Efforts
00:00/00:00
Listen to this article
1x
Subscribe now
Listen to the full version
Listen to the full version
Statistical errors remain after the Center for Drug Evaluation temporarily cut off public access to the information earlier this year.
New data discrepancies involving generic drug approvals in China have added to concerns that led a national regulator to suspend public access to the information for more than two weeks earlier this year to correct the problems.
Statistical errors persist in the restored Center for Drug Evaluation (CDE) data, and problems with the drug approval data submission process have surfaced as an issue, Caixin has learned.
You've accessed an article available only to subscribers
VIEW OPTIONS
Unlock exclusive discounts with a Caixin group subscription — ideal for teams and organizations.
Save an extra $50. Introductory offer for new readers. Subscribe now.
- RELATED
Share this article
Open WeChat and scan the QR code
- DIGEST HUB
Digest Hub
Back
Explore the story in 30 seconds
- China's drug approval data faced discrepancies, causing temporary suspension and leading to ongoing statistical errors despite correction claims.
- A blogger identified persistent issues with confidence interval mismatches in the data, affecting four generic drugs, highlighting problems in the submission process.
- Identical bioequivalence data errors for two different drugs indicate submission phase issues, traced back to an outdated template, prompting corrective actions.
AI generated, for reference only
Who’s Who
- Hainan General Sanyo Pharmaceutical Co. Ltd.
- Hainan General Sanyo Pharmaceutical Co. Ltd. discovered discrepancies between the confidence intervals in the CDE’s published data and what they had submitted, which went unnoticed until highlighted. The company's bioequivalence testing staff mentioned that prior to this issue, the CDE data held little reference value for them, and as long as approvals were granted, the publication of data was not a significant concern.
- Huazhong Pharmaceutical Co. Ltd.
- Huazhong Pharmaceutical Co. Ltd. manufactures clindamycin hydrochloride capsules, an antibiotic mentioned in the article. The company is involved in a data discrepancy issue where its drug's bioequivalence data, used to demonstrate performance similarity to brand-name counterparts, appeared identical to another drug. The error is attributed to using an outdated template during the data submission phase, managed by Anhui Wanbang Pharmaceutical Technology Co. Ltd., and is being resolved.
- China Resources Sanjiu Medical & Pharmaceutical Co. Ltd.
- China Resources Sanjiu Medical & Pharmaceutical Co. Ltd. (Sanjiu Medical) is involved in producing tenofovir alafenamide fumarate tablets for treating chronic hepatitis B. Data discrepancies, including identical bioequivalence data shared with another drug, were attributed to outdated templates used during data preparation. These errors highlight issues in the data submission phase overseen by Anhui Wanbang Pharmaceutical Technology Co. Ltd. and a hospital affiliated with Liaoning University of Traditional Chinese Medicine.
- Anhui Wanbang Pharmaceutical Technology Co. Ltd.
- Anhui Wanbang Pharmaceutical Technology Co. Ltd. is a contract research organization involved in managing clinical trials for two different generic drugs, clindamycin hydrochloride capsules and tenofovir alafenamide fumarate tablets. Both drugs had identical bioequivalence data discrepancies due to errors during the data submission phase. These errors likely stemmed from using an outdated template for publication, an issue currently being addressed with the journal involved.
AI generated, for reference only
What Happened When
- January 2025：
- A blogger under the name "Air-Moving Device" flagged data discrepancies regarding generic drug approvals in China.
- Before February 2025：
- The Center for Drug Evaluation (CDE) suspended public access to generic drug approval information to correct errors.
- 2025-02-10：
- The CDE restored public access to generic drug approval data, claiming errors had been corrected.
- 2025-02-10：
- "Air-Moving Device" discovered that statistical errors persisted in four generic drugs despite the data restoration.
- 2025-02-11：
- Hainan General Sanyo Pharmaceutical Co. Ltd. confirmed discrepancies between confidence intervals in their submitted data and what was published by the CDE.
- 2025-02-11：
- Representatives from Sanjiu Medical and a LUTCM-affiliated hospital acknowledged data discrepancies due to using an outdated template and are working to correct the issue with a journal.
AI generated, for reference only
- MOST POPULAR
Sign in with Google
Sign in with Facebook
Sign in with 财新