<?xml version="1.0" encoding="UTF-8"?><rss version="2.0"><channel><title>GxPlex — regulatory status changes</title><description>Recorded changes to the published status of tracked regulatory instruments. Reports status only; no advice or interpretation.</description><link>https://gxplex.com/</link><language>en</language><item><title>EMA AI reflection paper: status change</title><link>https://gxplex.com/instrument/ema-ai-reflection/</link><guid isPermaLink="true">https://gxplex.com/instrument/ema-ai-reflection/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ema.europa.eu/en/use-artificial-intelligence-ai-medicinal-product-lifecycle</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EMA work programme: status change</title><link>https://gxplex.com/instrument/ema-work-programme/</link><guid isPermaLink="true">https://gxplex.com/instrument/ema-work-programme/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ema.europa.eu/en/about-us/how-we-work/planning-reporting</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU AI Act: status change</title><link>https://gxplex.com/instrument/eu-ai-act/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-ai-act/</guid><description>unknown → in-force. status recorded as in-force (previously unknown). Source: https://eur-lex.europa.eu/eli/reg/2024/1689/oj</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 11: status change</title><link>https://gxplex.com/instrument/eu-gmp-annex-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-11/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU GMP Annex 22: status change</title><link>https://gxplex.com/instrument/eu-gmp-annex-22/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-gmp-annex-22/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU IVDR: status change</title><link>https://gxplex.com/instrument/eu-ivdr/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-ivdr/</guid><description>unknown → in-force. status recorded as in-force (previously unknown). Source: https://eur-lex.europa.eu/eli/reg/2017/746/oj</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU MDR: status change</title><link>https://gxplex.com/instrument/eu-mdr/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-mdr/</guid><description>unknown → in-force. status recorded as in-force (previously unknown). Source: https://eur-lex.europa.eu/eli/reg/2017/745/oj</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA AI guidance: status change</title><link>https://gxplex.com/instrument/fda-ai-guidance/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-ai-guidance/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA data integrity: status change</title><link>https://gxplex.com/instrument/fda-data-integrity/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-data-integrity/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA DHCoE: status change</title><link>https://gxplex.com/instrument/fda-dhcoe/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-dhcoe/</guid><description>unknown → draft. status recorded as draft (previously unknown). Source: https://www.fda.gov/medical-devices/digital-health-center-excellence</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FDA PCCP: status change</title><link>https://gxplex.com/instrument/fda-pccp/</link><guid isPermaLink="true">https://gxplex.com/instrument/fda-pccp/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>Health Canada ML: status change</title><link>https://gxplex.com/instrument/health-canada-ml/</link><guid isPermaLink="true">https://gxplex.com/instrument/health-canada-ml/</guid><description>unknown → draft. status recorded as draft (previously unknown). Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>IEEE 7000: status change</title><link>https://gxplex.com/instrument/ieee-7000/</link><guid isPermaLink="true">https://gxplex.com/instrument/ieee-7000/</guid><description>unknown → withdrawn. status recorded as withdrawn (previously unknown). Source: https://standards.ieee.org/ieee/7000/6781/</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>NIST AI RMF: status change</title><link>https://gxplex.com/instrument/nist-ai-rmf/</link><guid isPermaLink="true">https://gxplex.com/instrument/nist-ai-rmf/</guid><description>unknown → draft. status recorded as draft (previously unknown). Source: https://www.nist.gov/itl/ai-risk-management-framework</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>NMPA: status change</title><link>https://gxplex.com/instrument/nmpa-ai/</link><guid isPermaLink="true">https://gxplex.com/instrument/nmpa-ai/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://english.nmpa.gov.cn/</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S GMP Guide: status change</title><link>https://gxplex.com/instrument/pic-s/</link><guid isPermaLink="true">https://gxplex.com/instrument/pic-s/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://picscheme.org/en/publications</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>PIC/S PI 041: status change</title><link>https://gxplex.com/instrument/pics-pi041/</link><guid isPermaLink="true">https://gxplex.com/instrument/pics-pi041/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://picscheme.org/en/publications</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>21 CFR Part 11: status change</title><link>https://gxplex.com/instrument/us-21-cfr-part-11/</link><guid isPermaLink="true">https://gxplex.com/instrument/us-21-cfr-part-11/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>FSMA: status change</title><link>https://gxplex.com/instrument/us-fsma/</link><guid isPermaLink="true">https://gxplex.com/instrument/us-fsma/</guid><description>unknown → final. status recorded as final (previously unknown). Source: https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma</description><pubDate>Tue, 28 Jul 2026 00:00:00 GMT</pubDate></item><item><title>EU AI Act: added to tracker</title><link>https://gxplex.com/instrument/eu-ai-act/</link><guid isPermaLink="true">https://gxplex.com/instrument/eu-ai-act/</guid><description>Added to the tracker. Status not yet verified against the primary source. Source: https://eur-lex.europa.eu/eli/reg/2024/1689/oj</description><pubDate>Mon, 27 Jul 2026 00:00:00 GMT</pubDate></item></channel></rss>