FDA, EMA and MHRA, read for your pipeline.
Regulatory intelligence for life sciences: RegWatch reads the FDA, the EMA, the MHRA and ICH and says which product, trial or device a change reaches, citing the source.
What a life sciences team sees
Linnavec, a fictional group headquartered in Boston, Massachusetts, United States, runs RegWatch on its regulators. This is the alert it received for the U.S. Food and Drug Administration’s rule of 17 Aug 2026.
- FDA reclassifies ISH companion diagnostics for oncology therapeutics from class III to class II (official source, opens in a new tab)MEDIUM · relevance 85
- MHRA: amended UK Clinical Trials Regulations in full effect from 28 Apr 2026 (official source, opens in a new tab)MEDIUM · relevance 80
- EU Digital Omnibus on AI: AI Act high-risk rules for AI in IVDs apply from 2 Aug 2028 (official source, opens in a new tab)LOW · relevance 68
- FDA draft guidance on potency assessment for active immunotherapy products (official source, opens in a new tab)LOW · relevance 22
Linnavec is fictional. The regulators and publications are real. Not legal advice.
The regulators and topics in scope
RegWatch suggests the authorities for your markets; your team decides the scope and can add any source that publishes online.
- U.S. Food and Drug AdministrationUnited States (official site, opens in a new tab)
- European Medicines AgencyEuropean Union (official site, opens in a new tab)
- Medicines and Healthcare products Regulatory AgencyUnited Kingdom (official site, opens in a new tab)
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human UseGlobal (official site, opens in a new tab)
- European CommissionEuropean Union (official site, opens in a new tab)
- European Parliament and Council of the European UnionEuropean Union (official site, opens in a new tab)
- Cell and gene therapy
- Clinical trials
- Companion diagnostics
- In vitro diagnostics
- AI governance
- Manufacturing quality
How life sciences teams run it
Device classification and submissions
The FDA’s reclassification of ISH companion diagnostics for oncology from class III to class II, effective 16 September 2026, can turn a planned PMA into a 510(k). The alert names the diagnostic and the submission plan it changes.
Clinical trial transparency
The amended UK Clinical Trials Regulations took full effect on 28 April 2026. The alert explains which trials run under the old and new rules, and the obligation for lay results summaries carries its approved template as evidence.
Set aside, with the reason
An FDA draft guidance on potency for active immunotherapy products scored 22 out of 100 for a gene and cell therapy company with none in its pipeline, and was dismissed with the reason on record.
Trial and co-development agreements
RegWatch Legal reviews clinical trial and co-development agreements for results-publication and transparency duties, one row per agreement, each cell cited. Outputs are drafts for professional review.
Questions
Do you cover ICH guidelines and EU legislation as well as agencies?
Yes. Standard setters such as ICH, and the Official Journal of the EU for regulations such as the AI Act and the IVDR, are sources like any agency’s site. Your watchlists decide which are read.
Can RegWatch tell us when something does not apply?
Yes. Findings that do not apply are set aside with a reason, and a dismissed alert keeps the reason your team gave. A reviewer can see what was read and why it was left out.
How fast can we start?
After the demo, the onboarding agent drafts your company profile from your website and a short brief, then suggests jurisdictions, topics and sources. Your team confirms them, invites colleagues and sets each watchlist’s schedule. The first alerts arrive after the first run, which you can start on demand.
Guides
- Regulatory Intelligence vs Horizon Scanning vs Change Management: Definitions UntangledRegulatory intelligence, horizon scanning and change management are three stages of one pipeline. Each definition is anchored in a standard setter's text, with an ownership matrix for who does what, how often and with what evidence.
- The Regulatory Horizon Scanning Process: 7 Steps From Sources to Board ReportA seven-step operational playbook for regulatory horizon scanning, from scoping and source mapping through triage and ownership to the board report. It includes a full RACI table, a triage rubric with dispositions, and four defined KPIs.
- How Many Regulatory Changes Happen Per Year? The Statistics, SourcedNo single global number exists, so this page publishes the defensible ones: 2,441 US final rules in 2025, 2,575 EU legal acts, 1,120 UK statutory instruments and 61,228 regulatory events one vendor tracked worldwide in 2022, each dated and sourced.
See a life sciences demo on your agencies.
Name the agencies and markets your programs answer to. The demo runs on them.