The RegIntelHub Weekly

Global PV updates, distilled.

👀 This Week’s Highlights

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🇧🇷 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.

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🇬🇧 United Kingdom - Updated MHRA Guidance for Medicine & Device CTs

MHRA updated two core guidance documents:

• ​Clinical trials for medicines: apply for authorisation in the UK (13 Nov 2025) - Added 'IVD process flow diagram'.
• ​Clinical investigations for medical devices (12 Nov 2025)
  New section 'Pilot of a medical device clinical investigation fee waiver programme for micro and small sized enterprises'.

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🌍 Other Updates in Brief

Here’s what else moved this week across the regulatory landscape:

• 🇪🇺 EMA — Incident Management Plan updated (14 Nov 2025)​
  Expanded scope + updated procedures for handling quality, efficacy and safety incidents across the EU network.
• 🇨🇭 Swissmedic — Vigilance-News now multilingual (18 Nov 2025)​
  Edition 35 introduces English as the primary language for PV articles, with DE/FR/IT summaries.

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Until next week — stay compliant, stay curious.

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⚖️ Disclaimer
This newsletter is for informational purposes only and does not constitute professional or legal advice.
All summaries are based on publicly available regulatory information. Always verify requirements with the relevant authority or qualified professional before implementation.
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