Update: 在最近公布的《全国药品集中采购文件》中，增加了两项关于集采药品生产环节变更的规定：变更时需公开变更内容、未发生变更的企业在同等价位时优先入选。

这两项规定明显弱于之前征求意见稿中的硬性规定：首个中选周期内不得进行重要生产环节的变更，否则取消中选资格。

大概是多方博弈的结果，baby steps也好吧。

DOGE/Musk preferentially cancelled grants and contracts to recipients in counties that voted for Harris in 2024.

Among cancellations with election data available, 92.9% and 86.1% cancelled grants and contracts went to Harris counties, representing 96.6% and 92.4% of total dollar amounts.

Thread: prevalence of post-approval changes in generic drugs and jicai (集采) drugs.

I analyzed >160k supplemental filings and found widespread post-approval changes in generics and jicai drugs. Importantly, jicai drugs underwent more changes than non-jicai counterparts.

bsky.app/profile/airm...

一致性评价是确保仿制药有效、安全的关键监管措施。然而，若仿制药在通过一致性评价后，生产环节发生变化，是否依旧符合与参比试剂的一致性？

实际上，一款仿制药在通过一致性评价后，可对原材料供应商、生产工艺、生产厂址等多项生产环节进行变更，而无需重新进行一致性评价，多数情况只需在省级药监部门进行备案。

我分析了国家药监局公布的2019年至今的16万余条药物补充备案，发现通过一致性评价的仿制药、进入集采的药品中，广泛存在过评后生产环节的变更。

并且，进入集采的药品，相对于同成分但未进入集采的药品，进行了更多此类变更。

这些变更并非一定会影响药效、安全性，但仍需解决如何对此进行有效监管的问题。

一致性评价是确保仿制药有效、安全的关键监管措施。然而，若仿制药在通过一致性评价后，生产环节发生变化，是否依旧符合与参比试剂的一致性？

实际上，一款仿制药在通过一致性评价后，可对原材料供应商、生产工艺、生产厂址等多项生产环节进行变更，而无需重新进行一致性评价，多数情况只需在省级药监部门进行备案。

我分析了国家药监局公布的2019年至今的16万余条药物补充备案，发现通过一致性评价的仿制药、进入集采的药品中，广泛存在过评后生产环节的变更。

并且，进入集采的药品，相对于同成分但未进入集采的药品，进行了更多此类变更。

这些变更并非一定会影响药效、安全性，但仍需解决如何对此进行有效监管的问题。

It’s weird seeing my data contributing to public discussions in China — something I’ve wanted to do from the start, but for obvious reasons I cannot post inside the GFW.
A small part of me wants some credit, but it’s more the powerlessness that I can’t explain and defend my data on my own terms.

Glaring data duplication and discrepancies in NMPA's generics trial data, caught using multiple different methods.
I believe they cannot be attributed to simple "editing errors" as claimed by NMPA.
This points to potential fraud, negligence, and poor NMPA oversight.

Thread: data manipulation and discrepancies in generics clinical trials that cannot be attributed to "editorial errors" by NMPA
1) An instance of blatant data duplication in a clinical trial for an HBV drug, appearing in material published by the drugmaker/clinical trial team.

The saga of data issues in Chinese clinical trials continues...
While NMPA works on their internal audit, I found more instances of data discrepancies that are hard to attribute to "editorial errors", as NMPA claimed in response to my previous posts. This gets technical but bear with me.

深层次分析药监局公布的仿制药一致性数据时，发现了难以用“编辑错误”解释的统计学问题。不知问题具体出在哪一个环节，临床，药企，还是药监局。
但很明显的问题经过层层审核未被发现，至少说明药监局对数据的分析核查能力不足。加上之前的低级“编辑错误”，药监局未能对一致性评价起到该有的监管作用。

The saga of data issues in Chinese clinical trials continues...
While NMPA works on their internal audit, I found more instances of data discrepancies that are hard to attribute to "editorial errors", as NMPA claimed in response to my previous posts. This gets technical but bear with me.

Follow-up: NMPA has made all downloads to trial data unavailable. Internal auditing is my guess.
I do think that some of these data discrepancies could be honest editorial mistakes as NMPA claimed, especially ones where the entire result section was lifted from another trial.
But…

NMPA Center for Drug Evaluation has issued a statement claiming that these data discrepancies are due to editorial errors on their end when making the trial results public, and they have corrected the errors.

www.cde.org.cn/main/news/vi...

As of 1/24 2:00PM Beijing time, NMPA NDE has updated the publicly available results file for 2 of the 5 examples of suspected data fraud that I listed in my tweet. The edits are made by a 魏春敏, who works at NMPA NDE.

I do want to point out that I’m in no way against centralized, volume-based procurement and generics. In fact, I think they’re fundamentally a great idea for patients, given that their safety and effectiveness are demonstrated with rigorous testing and proper regulatory oversight.

I hate to plug my own research, but I believe this is an important issue — fraud and plagiarism with real world consequences for healthcare and the drug industry in China.
What strikes me most is how blatant and dumb the fraud is — simple copy-and-paste plagiarism of a competitor drug’s trial.

Thread: I found data fraud in multiple clinical trials for generic drugs in China.
I've seen limited coverage outside China of the recent controversy over 集采 — centralized procurement of drugs, especially generics. It is a hugely important issue close to my heart.