FDA · EMA · PMDA · ISO · ICH
Regulatory Insights
What regulators expect and what is changing, with practical guides, checklists and templates for quality and regulatory teams in medical devices and pharma.
5 reports · 25 regulation sources · 27 AI regulation guides · 108 guides
Guides
Deep Research reports
- Transitioning to Quality Management System Regulation (QMSR): A Systemic Analysis of Olympus Medical Systems Corporation What FDA's October 2026 warning letter to Olympus shows about global CAPA oversight, complaint handling and corrective actions under the QMSR.
- FDA QMSR 2026: What Warning Letters Reveal About Medical Device Quality Failures What FDA inspects under the QMSR since February 2, 2026, and what device warning letters show about internal audits, suppliers, management review and CAPA.
- The Hidden Regulatory Risks Behind the GLP-1 Boom: Evidence from FDA Warning Letters What FDA warning letters from 2024 to 2026 show about compounded semaglutide and tirzepatide, misleading telehealth claims and unapproved peptides.
- Why Sterile Drug Manufacturing Keeps Failing: Lessons from FDA Warning Letters What FDA warning letters show about smoke studies, media fills, environmental monitoring, OOS retests and quality unit failures in sterile drug plants.
- Why CAPA Fails: Recurring Quality Problems in FDA Warning Letters What FDA warning letters from 2017 to 2026 show about CAPA triggers, root cause analysis, effectiveness checks, other-batch investigations and risk files.
Regulation maps
- Japan, US, and EU Medical Device and Pharma Rules: 2026 Guide for AI Use A map of the main Japan, US and EU medical device and pharma sources, their 2026 status, and what each allows when you use it in AI tools.
- Can You Use ISO, IEC, and ICH in AI? 2026 Guide to Global Standards Which global standards and guidelines you may use in AI, how their licences differ from regional law, and what changes in 2026.
- Medical Device Regulations Map 2026: Japan, US, EU, and Global Standards for AI Use One map of medical device rules across Japan, the US, the EU and global standards, stage by stage, with notes on using each source in AI tools.
- Pharmaceutical Regulations Map 2026: Japan, US, EU, ICH, and PIC/S for AI Use Pharma rules across Japan, the US, the EU, ICH and PIC/S in one map, with 2026 changes such as draft Annex 22 and notes on using each source in AI.
- IVD Regulations Map 2026: IVDR Deadlines, US and Japan Rules, and Global Standards for AI Use How IVDs are regulated in the EU, the US and Japan in 2026: IVDR classes and deadlines, the frameworks that cover IVDs elsewhere, and notes for AI use.
Regulation sources by region
One guide per source: what it is, where the current text lives, and what to check before using it in AI tools.
Japan
7PMD Act, ordinances, Japanese Pharmacopoeia and PMDA
- Japan's PMD Act and MHLW Ordinances: A Guide for US Pharma and Device Companies
- Japan's GMP, GQP and GVP Ordinances Explained for US Drug Makers
- Japan's QMS Ordinance for Medical Devices: How It Compares with ISO 13485 and QMSR
- The Japanese Pharmacopoeia: What US Manufacturers Need to Know
- PMDA Notifications, Review Guidelines and Q&As: How to Find and Use Them
- Japanese Package Inserts and RMPs on the PMDA Website: Access and Reuse Rules
- e-Gov Law Search: Finding Japan's Pharmaceutical and Medical Device Laws
United States
4FDA guidance, inspections and 21 CFR
European Union
9MDR, IVDR, CTR, EU GMP and the EU databases
- EU MDR 2017/745 in 2026: Status, Transition Deadlines and Working With the Text
- EU IVDR 2017/746 in 2026: Transition Timelines and Practical Guidance
- EU Clinical Trials Regulation 536/2014: What Sponsors Need to Know Now
- EU GMP Annex 1, Annex 11 and Annex 15: Current Status and Revisions
- EudraLex Explained: The Rules Governing Medicinal Products in the EU
- EMA Scientific Guidelines, GMP, GCP and GVP: Where to Find Them and How to Use Them
- MDCG Guidance for MDR and IVDR: A Practical Guide
- EUDAMED Public Data: What Is Available and How to Use It
- EudraGMDP: GMP Certificates and Non-Compliance Reports Explained
Global
5ICH, IMDRF, ISO, IEC and PIC/S
- ICH Quality Guidelines Q7 to Q12: A Practical Guide With Licensing Notes
- IMDRF Guidance Documents: What They Are and How to Use Them
- ISO 13485 and ISO 14971: What They Require and Why You Cannot Simply Load Them Into AI
- IEC 62304 and IEC 60601: Medical Device Software and Electrical Safety Standards Explained
- PIC/S GMP Guide (PE 009): What It Is and How It Relates to EU GMP
AI regulation by region
One guide per AI law, guideline or standard: what it requires, where it stands in 2026, and what its terms allow when you use it in AI tools.
Japan
7AI Promotion Act, government guidelines, copyright and APPI
- Japan's AI Promotion Act: What US Companies Need to Know in 2026
- Japan AI Guidelines for Business Version 1.2: What Changed in 2026
- Japan's Article 13 AI Guideline: Ensuring Appropriate AI R&D and Use
- Japan AI and Copyright: Article 30-4, RAG, and the Agency for Cultural Affairs Guidance
- Japan PPC Alert on Generative AI: Personal Data Rules for Prompts
- Japan's APPI and AI: The 2026 Amendment and Personal Data in RAG
- Japan's AI Security Guidelines: Prompt Injection and RAG Defenses (MIC 2026)
United States
7NIST frameworks, FDA AI guidance, the FTC and state law
- NIST AI Risk Management Framework (AI RMF 1.0): 2026 Guide and Revision Status
- NIST AI 600-1 Generative AI Profile: The 12 Risks and How to Use Them
- FDA Draft Guidance on AI for Drug Regulatory Decisions: The 7-Step Credibility Framework
- FDA PCCP Guidance for AI-Enabled Devices: Planning Model Updates Before Clearance
- FDA Draft Guidance on AI-Enabled Device Software Functions: Lifecycle and Submissions
- FTC and AI: Deceptive AI Claims, Operation AI Comply, and 2026 Enforcement
- Colorado AI Act in 2026: SB24-205 Replaced by the ADMT Law (SB26-189)
European Union
7AI Act, GPAI Code, GDPR, copyright, MDR and IVDR
- EU AI Act in 2026: What the Digital Omnibus Changed and What Applies Now
- EU AI Act Implementation Timeline 2024-2028: Every Key Date After the Omnibus
- EU General-Purpose AI Code of Practice: Transparency, Copyright, and Safety Chapters Explained
- GDPR and AI in 2026: EDPB Opinion 28/2024 and the Digital Omnibus Proposals
- EU DSM Copyright Directive and AI: Text and Data Mining Opt-Outs Explained
- AI Medical Devices Under the EU MDR and AI Act: How the Two Rules Fit Together
- AI Diagnostics Under the EU IVDR and AI Act: Classes, Performance Studies, and Dates
Global
6ISO/IEC AI standards, OECD and UNESCO
- ISO/IEC 42001 AI Management System: Certification, Status, and AI Use of the Standard
- ISO/IEC 23894 AI Risk Management Guidance: What It Covers and Licence Limits for AI Use
- ISO/IEC 22989 AI Concepts and Terminology: The Generative AI Amendment and AI Use Limits
- ISO/IEC 23053 Framework for AI Systems Using Machine Learning: Overview and AI Use Limits
- OECD AI Principles: The 2024 Update, 47 Adherents, and How to Reuse Them
- UNESCO Recommendation on the Ethics of AI: Principles, Readiness Assessment, and Strict AI Reuse Terms
Latest guides
- USP <797> Quality Assurance Program: Documentation Requirements and Checklist What a USP <797> QA/QC program must document after the 2023 revision: SOPs, designated person, release checks, recalls, training records and annual review.
- Pharmaceutical Quality Assurance and the QMS: Roles, Regulations and 2026 Priorities What pharmaceutical QA does under 21 CFR 211.22 and ICH Q10, how QA differs from QC in pharma, what FDA cites most, and 2026 priorities such as QMM.
- Regulatory Gap Analysis and Impact Assessment: A Practical Method for Life Sciences How to run a regulatory gap analysis in life sciences, with QMSR, EU reform and Annex 11 examples, how it differs from a government RIA, and a template.
- Regulatory Submission Management and Automation: eCTD, Tools and What to Automate How regulatory submissions are planned, assembled and published: eCTD 4.0 and eSTAR timelines, submission software, what to automate and AI review.
- RIM Software: Regulatory Information and Document Management Explained What regulatory information management (RIM) software does, how it differs from document management, why IDMP and eCTD 4.0 matter, and how to choose.
- Regulatory Intelligence: Sources, Process, Software and the Role of AI What regulatory intelligence is, the three parts of a mature RI function, what to look for in RI software, and where AI helps and where it does not.
Regulatory Affairs & Intelligence
All 20 →Regulatory submissions, gap and impact analysis, regulatory document review and keeping up with regulatory change.
- Medical Device Regulatory Affairs in 2026: Role, Responsibilities and Trends
- Medical Device Regulatory Software: RIM, Submissions and Regulatory Intelligence Tools
- Regulatory Affairs in Life Sciences: What the Function Does and How It Is Changing
- Regulatory Compliance Management for Life Sciences: Building a System That Holds Up
- Regulatory Change Management: How to Monitor and Act on Regulatory Changes
- Regulatory Intelligence: Sources, Process, Software and the Role of AI
- RIM Software: Regulatory Information and Document Management Explained
- Regulatory Submission Management and Automation: eCTD, Tools and What to Automate
FDA, ISO 13485 & EU MDR
All 39 →Inspection readiness, FDA 483s and warning letters, QMSR, ISO 13485 audits and EU MDR technical documentation.
- QMSR Compliance Software: What Medical Device Makers Need After the FDA's 2026 Transition
- FDA QMSR Checklist: An ISO 13485 Gap Analysis for U.S. Device Makers
- EU MDR Technical Documentation Checklist: Annex II, Annex III and the GSPR Matrix
- FDA 483 Response Checklist: How to Answer Observations in 15 Business Days
- ISO 13485 Internal Audit Checklist: QMSR-Ready for 2026
- ISO 13485 in 2026: Requirements, QMSR Alignment and Compliance Guide
- EU MDR in 2026: Deadlines, the Simplification Proposal and a Compliance Roadmap
- FDA Form 483 Explained: What It Means, Top Observations and How to Respond
Pharma & GMP
All 45 →Pharmaceutical quality assurance, GMP and GxP compliance, data integrity and inspection readiness.
- GMP Data Integrity Checklist: ALCOA+, Audit Trails and 2026 Expectations
- ICH Q9(R1) Quality Risk Management Template: What Changed and How to Apply It
- What Is GMP? Good Manufacturing Practice Explained for 2026
- Pharmaceutical Manufacturing in 2026: Onshoring, Advanced Manufacturing and What FDA Expects
- GxP Compliance: What GMP, GLP, GCP and GDP Require and How to Stay Compliant
- GMP Compliance and GMP Inspections: What FDA Investigators Look For in Drug Facilities
- GMP and GxP Software: Validation, Data Integrity and Automation in 2026
- GMP Audits: How to Plan and Run Internal, Supplier and Mock Inspection Audits
Medical Devices
All 41 →Quality management, regulatory compliance and documentation review across the medical device lifecycle.
- ISO 14971 Risk Management Checklist: What FDA Inspectors Look for in 2026
- Medical Device Manufacturing in 2026: Regulations, Tariffs and Automation
- Medical Device Compliance in 2026: An FDA and EU Regulatory Compliance Guide
- Medical Device Regulations Explained: FDA Classes, Pathways and 2026 Updates
- Medical Device Automation: Validating Automated Manufacturing and QA Under QMSR
- Medical Device Compliance Software: A 2026 Buyer's Guide to Quality Management Tools
- Medical Device Certification Explained: FDA Clearance, CE Marking and ISO 13485
- Medical Device Audits in 2026: Internal, Supplier, Notified Body and MDSAP