Company environment · Oral FDC · NMPA / CDE
A combination tablet under review in China
Under review; answering a formal deficiency notice. Start at the top to see what the company does, then the jobs AI models were given here and how each scored.
1What does this company do?
A drug company seeking approval in China for a tablet that combines two existing medicines.
Combining two known drugs in one tablet still needs full quality evidence and proof it behaves like taking both.
2Where is the product on its way to patients?
The application is under review, and China’s drug evaluation center has sent a list of deficiencies.
- 1Discovery
- 2Lab & animal studies
- 3Human trials
- 4Filing & review
- The product is here
- 5Approved
- 6On the market
The company has 80 days to answer questions on impurities, manufacturing, dissolution and specifications.
3What is happening right now?
The deficiency notice arrived 31 January 2024; the 80-day clock is running.
Each team drafts its part of the answer from the file as it stands, without leaning on answers that were only written later.
4Which jobs were the models given?
6 jobs, each graded against a specialist’s checklist.
Scores are checks passed out of checks in the list. Each model ran each job once.
This company’s files stay private.
The jobs above are scored. The files, the model’s steps, and each check stay unpublished, because they come from a real product’s records. To follow a job all the way down, open one of the public environments.
Havenor Therapeutics (fictional, fully published) →
Broad Institute (real, public FDA record) →