https://rafihive.com/ 2026-09-19 weekly 1.0 https://rafihive.com/pricing 2026-09-19 monthly 0.8 https://rafihive.com/sample-output 2026-09-17 monthly 0.8 https://rafihive.com/sources 2026-08-14 monthly 0.8 https://rafihive.com/assets/diagrams/regulatory-source-hierarchy.png What binds and what only guides: legislation, guidance, questions and answers, templates, then agency practice — with draft and superseded material kept outside the hierarchy rather than blended into it. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/ai-governance 2026-08-14 monthly 0.7 https://rafihive.com/evaluation 2026-09-09 monthly 0.6 https://rafihive.com/use-cases 2026-08-14 monthly 0.7 https://rafihive.com/regulatory-affairs-ai-agent 2026-09-14 monthly 0.9 https://rafihive.com/gap-check 2026-08-14 monthly 0.9 https://rafihive.com/packaging-check 2026-08-19 monthly 0.9 https://rafihive.com/security 2026-08-14 monthly 0.6 https://rafihive.com/about 2026-08-14 monthly 0.5 https://rafihive.com/contact 2026-08-14 monthly 0.6 https://rafihive.com/privacy 2026-09-09 yearly 0.3 https://rafihive.com/terms 2026-08-14 yearly 0.3 https://rafihive.com/imprint 2026-09-09 yearly 0.3 https://rafihive.com/guides 2026-08-14 monthly 0.8 https://rafihive.com/guides/eu-variation-classification 2026-09-17 monthly 0.8 https://rafihive.com/assets/diagrams/eu-variation-classification-decision-tree.png Classifying an EU post-authorisation change: screen Annex I of the Variations Regulation for an extension first, then work through the Classification Guideline's scope and conditions. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/guides/eu-ectd-module-1 2026-09-17 monthly 0.8 https://rafihive.com/assets/diagrams/eu-ectd-module-1-section-map.png EU eCTD Module 1, section by section: 1.0 to 1.2 and the product information in 1.3 against the conditional sections 1.4 to 1.10. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/guides/mrp-dcp-variations 2026-09-17 monthly 0.8 https://rafihive.com/guides/centralised-procedure-variations 2026-09-17 monthly 0.8 https://rafihive.com/guides/nitrosamine-risk-assessment 2026-08-14 monthly 0.8 https://rafihive.com/assets/diagrams/nitrosamine-risk-assessment-three-steps.png The three-step EU nitrosamine exercise, with the question that decides whether each step holds — and how the applicable limit is set. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/guides/elemental-impurities-ich-q3d 2026-08-14 monthly 0.8 https://rafihive.com/assets/diagrams/ich-q3d-elemental-impurities-approaches.png The drug product, component and summation approaches of ICH Q3D side by side. All three end at the same decision point: 30% of the permitted daily exposure. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/guides/asmf-or-cep 2026-08-14 monthly 0.8 https://rafihive.com/assets/diagrams/asmf-cep-full-details-route-comparison.png The three routes to section 3.2.S — full details, a Certificate of Suitability, or an Active Substance Master File — and what the applicant owes whichever is used. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/insights 2026-09-17 weekly 0.8 https://rafihive.com/insights/eu-variations-2026 2026-09-17 monthly 0.8 https://rafihive.com/insights/eu-pharmaceutical-legislation-reform-2026 2026-09-17 weekly 0.8 https://rafihive.com/insights/electronic-product-information-epi-2026 2026-09-17 monthly 0.8 https://rafihive.com/assets/diagrams/epi-product-information-data-flow.png What ePI changes: the unit of work stops being a QRD document and becomes structured FHIR data managed through EMA's PLM Portal — which changes how far a single error reaches. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/insights/ectd-v4-eu-transition 2026-09-19 monthly 0.8 https://rafihive.com/assets/diagrams/ectd-v4-eu-transition-timeline.png EMA's published eCTD v4.0 plan for new centrally authorised MAAs: optional since December 2025, strongly recommended from Q1 2027, mandatory from Q1 2028. The dates have moved before. https://creativecommons.org/licenses/by/4.0/ https://rafihive.com/insights/what-is-a-regulatory-affairs-ai-agent 2026-09-17 monthly 0.8 https://rafihive.com/insights/hallucinated-citations-regulatory-ai 2026-09-17 monthly 0.8