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 Pharmacovigilance Guidelines for the Preparation of PSRs (Ministerial Resolution No. 1110, Aug 2012).
👉 See all requirements and source documents on the Bolivia page of RegIntelHub.​

🇧🇼 Botswana — New PV Guidance for MAHs

BoMRA published an updated Pharmacovigilance Guidance Document for MAHs (effective 28 March 2025).
Key sections revised: QPPV nomination, RMP format and criteria, PSUR submission, and classification of safety variations.
Most notable change — PSURs must now be submitted via BRIMS, not by CD or email.
👉 Explore the updated guidance and all requirements on the Botswana page of RegIntelHub.

🇨🇭 Switzerland — Updated Guidance (v5.0)

Swissmedic released version 5.0 of “Drug Safety Reporting Duties in Switzerland” (MU101_20_004) with immediate effect.
Changes include updated contact details and cross-references to the TPA, VAM, and FAQs — no operational impact, but ensure your SOPs cite the latest version.
👉 The newest document and summary are already available on the Switzerland page of RegIntelHub.

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🌍 Other Updates in Brief

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

• 🇨🇷 Costa Rica – Progress on two key PV regulations:
  • Modification of the National Pharmacovigilance System Regulation (Decree N°35244-S)
  • Modification of the Good Pharmacovigilance Practices Regulation (Decree N°39417-S)
  Both drafts are under final legal review by the Dirección de Asuntos Jurídicos (DAJ) before public consultation.
• 🇬🇧 United Kingdom – Six-month countdown to new Clinical Trials Regulations (effective Apr 2026).
• 🇪🇺 EU (HMA/EMA) – Updated Recommendation on Decentralised Elements in Clinical Trials and Auxiliary Medicinal Products in CTs (effective Dec 2025).
• 🇦🇹 Austria – Revised DHPC/Educational Material guideline; updated process for joint MAH distributions.
• 🇩🇰 Denmark – New Q&A on Sponsor Responsibilities and updated Protocol Template aligned with ICH GCP E6(R3).
• 🇫🇮 Finland – Updated Instructions for Preparing Additional Risk Minimisation Materials; new safety info symbol now required.

🗣️ Join the Conversation

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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.
RegIntelHub assumes no liability for actions taken based on this content.