Knowledge index
Life Sciences Regulation (FDA and EU)
FDA and EU rules for pharma, clinical trials and medical devices: 21 CFR, ICH guidelines, EU pharma law and EUDAMED.
Works with
Claude Code, Codex, Claude, ChatGPT, Grok and any MCP client
Domain
Life sciences
Size
5 regulatory sources
Coverage
Current US and EU pharma and device regulation, including ICH E6(R3) and EUDAMED
Example questions
What are the sponsor's responsibilities for trial oversight under ICH E6(R3)?
What does 21 CFR Part 11 require for electronic records and signatures?
What must a CONSORT trial report say about participant flow?
Use cases
Check what a specific CFR part or ICH guideline requires before filing.
Confirm trial oversight, consent and reporting obligations against ICH E6(R3), SPIRIT and CONSORT.
Answer questions on adverse event reporting, electronic records and GDPR Article 9.
About this index
Life sciences companies work against several overlapping rulebooks: FDA regulation under 21 CFR and the Orange Book in the US, EU pharmaceutical legislation and EUDAMED for medical devices, and the ICH guidelines that trial sponsors in both regions follow. Some of these are moving targets. ICH E6(R3), the current Good Clinical Practice guideline, took effect in July 2025 and replaced E6(R2), and EUDAMED's first modules become mandatory across the EU from May 2026. This index follows US and EU pharma and device regulation together and is kept current as the CFR, the Orange Book, and ICH and EMA guidance change.
Owner
FDA, European Commission, EMA and ICH
Coverage
Current US and EU pharma and device regulation, including ICH E6(R3) and EUDAMED
License and credit
Data comes from the FDA, EUR-Lex, EMA, ICH and EUDAMED. Kapa provides this page and the MCP URL. It is not an official product of any of them and implies no endorsement. Credit the source when citing.
Caveats
Regulations are indexed for search. Confirm the current official text before relying on it. This is not legal or regulatory advice.
Add to your agent
Copy the setup prompt and paste into your agent.
Or add it manually
MCP URL
https://lifescienceindex.mcp.kapa.ai
Claude Code
Codex
Claude
ChatGPT
Grok Bot
Other
claude mcp add --transport http
life-sciences
https://lifescienceindex.mcp.kapa.ai
Then run /mcp and finish sign-in in the browser.
Example
With the MCP, Claude cites the actual records
Same question, same model (Opus 5.5, high effort). Left: Claude with web search. Right: Claude with this index.
Normal Claude
Web search
With knowledge index
Life sciences
MCP
Frequently asked questions
What is a knowledge index?
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A searchable index of a public data source, like NASA's aviation safety reports, that your agent can query over MCP.
How do I add one to my agent?
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How is this different from web search?
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Is it free?
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Are these official connectors?
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Can I create my own index?
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