The RegIntelHub Weekly Global PV updates, distilled - powered by our community Every issue comes from what you share - updates posted in the group, messages you send, or things you tag us in. If you discover a regulatory update, new guideline, portal change, or anything that could help others: 👉 Send it to info@regintelhub.com or DM/tag us on LinkedIn. If we missed something, tell us - this newsletter gets better because you help improve it. Thank you to everyone who contributed this week....
about 1 month ago • 2 min read
The RegIntelHub Weekly Global PV updates, distilled - powered by our community Every issue comes from what you share - updates posted in the group, messages you send, or things you tag us in. If you discover a regulatory update, new guideline, portal change, or anything that could help others: 👉 Send it to info@regintelhub.com or DM/tag us on LinkedIn. If we missed something, tell us - this newsletter improves because you help improve it. These updates were brought to you by members of the...
about 2 months ago • 1 min read
The RegIntelHub Weekly Global PV updates, distilled. 👀 This Week’s Highlights 🇧🇷 Brazil - Anvisa Updates the Medicines Regulatory Library (14 Nov 2025) Anvisa released an updated, consolidated Medicines Regulatory Library document, covering all current regulations across MA, GMP, inspections, CMED pricing, PV, advertising, and post-marketing oversight.Why it matters: gives MAHs a single, structured view of all rules in force — ideal for compliance mapping and SOP auditing. 🇬🇧 United Kingdom -...
about 2 months ago • 1 min read
The RegIntelHub Weekly Global PV updates, distilled. 👀 This Week’s Highlights This week’s updates focus on documentation, submissions, and system updates - from CTIS changes in the EU to new PSMF requirements in South Africa. 🇪🇺 EU — CTIS Sponsor Handbook Updated (v6.1) After nearly 18 months, EMA has released an updated version (6.1) of the Clinical Trial Information System (CTIS) Sponsor Handbook (dated 7 Nov 2025). Key updates include: Clarifications on Multi-Factor Authentication and OMS...
2 months ago • 1 min read
The RegIntelHub Weekly Global PV updates, distilled. 👀 This Week’s Highlights Three updates this week deserve your attention — they directly impact how MAHs handle safety reporting and compliance. 🇧🇴 Bolivia — PSURs Now Mandatory From 28 October 2025, PSUR submission becomes mandatory for all MAHs registered with AGEMED.Circular No. 37/2025 introduces clear submission frequencies based on product registration age — from semi-annual to every five years.Full details are set out in the...
2 months ago • 1 min read