Air-Moving Device
China and the world in data and graphs
一点浩然气 千里快哉风
airmovingdevice@gmail.com
- 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.
- Data source: doge.gov/savings — cancelled federal grants and contracts USAspending.gov — contract/grant recipient info github.com/tonmcg/US_Co... & github.com/nytimes/pres... — county-level election data
- I retrieved all publicly available cancellations from DOGE on 3/22, which according to DOGE is a subset of all cancellations. I then cross-referenced them to official spending data on USAspending using links provided by DOGE and ended up with 5,137 and 4,679 contracts and grants with rich metadata.
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View full threadIt is therefore possible that they made cancellations unbiasedly across the Trump-Harris political spectrum but preferentially disclosed ones to Harris counties for publicity purposes.
- 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...
- After passing bioequivalence tests, generics can undergo changes in supplier, manufacturing process or site. These are often submitted as supplemental filings to province-level drug admins, and no further BE tests are required. Here I quantified how prevalent these changes are.
- I analyzed supplemental filings disclosed by NMPA during 2019/1/1-2025/2/5 and found a total of >160k filings. I cross referenced these with generics that passed BE disclosed by NMPA (n = 1,988) and drugs that entered centralized procurement jicai disclosed by NHSA (n = 1,933).
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View full threadAgain, 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.
- 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。
- 国家药监局网站定期公开“境内生产药品备案信息”（https://www.nmpa.gov.cn/datasearch/search-result.html）。 经查询可见，许多药品会进行原料供应商、生产工艺、生产厂址的多项变更，并只需在省级药监部分进行备案。即使是进行了一致性评价的仿制药，进行此类变更后，也无需重新进行一致性评价。
- 为了分析通过一致性评价的仿制药和进入集采的药品，是否存在过评后、进入集采后进行变更的情况，我抓取了从2019-1-1到2025-2-5的16万余条药物补充备案信息。我将此信息与CDE公开的1988条过评药品信息和医保局公布的1933条集采药品信息进行了对比。 备案信息来源： www.nmpa.gov.cn/datasearch/s... （经业内权威数据库整理） 一致性评价药品信息： www.cde.org.cn 集采药品信息：上海医保局阳光采购网 www.smpaa.cn
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View full thread推广仿制药、集采制度是解决医保支付问题、为广大患者提供低价药品的必要的、有效的方法。 为应对、缓解患者和广大民众对仿制药和集采制度的质疑，药厂、药监部门、医保部门应扩大信息公开的力度并确保公开的信息及时准确。药监部门也应对于可能影响药效、安全性的过评后变更进行更加有效的审核与监管。
- 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.
