10. Roadmap of the Submission Process of a Clinical Trial
- 1 Mins to read
- DarkLight
10. Roadmap of the Submission Process of a Clinical Trial
- 1 Mins to read
- DarkLight
Article summary
Did you find this summary helpful?
Thank you for your feedback
10.1 Clinical Trial with Investigational Medicinal Product
10.2 Pediatric Investigation Plan (PIP)
A PIP is not required.
10.3 Clinical Study (Interventional or Observational)
COFEPRIS has lower expectations for observational studies which are considered to be low risk.
Was this article helpful?