Global PV updates, distilled - powered by our community
A deadline-heavy week. Iraq is switching to electronic ICSR reporting with a hard June cutover, and Costa Rica has opened two separate PV consultations โ both closing before mid-April.
Thank you to everyone who shared links, documents, and local insights by email or in Slack - this newsletter exists because of you ๐
๐ Start with the 10-Second Summary, then dive deeper if something touches your portfolio.
โฑ๏ธ 10-Second Summary (Read This First)
If you read nothing else this week:
๐ฎ๐ถ Iraq โ eReporting system launched for ICSR submission. CIOMS/XML route closes 1 June 2026.
๐จ๐ท Costa Rica โ two PV regulations open for consultation simultaneously. Deadlines: 7 April and 17 April 2026.
๐ณ๐ฎ Nicaragua โ MINSA publishes RMP submission guide and evaluation request form for human medicines.
๐ฒ๐ป Maldives โ Ministry of Health issues major revision of its PV and ADR reporting guideline.
๐ช๐ฌ Egypt โ GCP oversight guideline version 4 entered into force on 26 March 2026.
Details and links below ๐
๐ This Period's Highlights
๐ฎ๐ถ Iraq โ electronic ICSR reporting system goes live, legacy route closing June 2026
Iraq's drug authority has formally launched an industry eReporting system for ICSR submission, covering cases raised by marketing authorisation holders and local distributors. The existing CIOMS/XML submission route runs in parallel until 1 June 2026 โ after that date, only registered system users can submit.
- The new platform is the mandatory channel for all ICSRs from MAHs and local distributors in Iraq
- Circular 24806 (29 March 2026) formally launches the system; an industry eReporting manual has been published alongside
- Two months of parallel running before the legacy route closes permanently on 1 June 2026
What to do:
- Register on the eReporting system before 1 June โ do not wait until the legacy route closes
- Read the published eReporting manual to understand the submission workflow and technical requirements
- Brief local distributors or agents who currently submit on your behalf โ they need to transition too
- Update your Iraq ICSR process and SOPs to reference the new system
Official source: Circular 24806 and eReporting Manual available on RegIntelHubโ
๐จ๐ท Costa Rica โ two PV regulations open for public consultation simultaneously
Costa Rica's Ministry of Health has opened two separate consultations within days of each other โ one on Good Pharmacovigilance Practices, the other on the structure of the National Pharmacovigilance System itself. With deadlines falling ten days apart in April, the window for engagement is narrow.
- Consultation 1 โ Good PV Practices: open from 23 March 2026, comments due 7 April 2026 using the observation matrix, to un.correspondencia@misalud.go.cr
- Consultation 2 โ National PV System: opens 6 April 2026, comments due 17 April 2026 using the comment form, to drpirs.consultapublica@misalud.go.cr
- Both consultations have structured templates โ use the designated form for each
What to do:
- Review both drafts โ the GVP consultation closes first on 7 April, prioritise accordingly
- Loop in regional regulatory or medical affairs teams covering Central America
- Submit using the correct template and email address for each consultation โ they are separate
โCosta Rica PV requirements on RegIntelHub
Official sources: GVP notice | National PV System noticeโ
๐ณ๐ฎ Nicaragua โ MINSA publishes RMP submission guide for human medicines
Nicaragua's Ministry of Health has released a User Guide for submitting Risk Management Plans, covering new active substances, biologicals, biotechnologicals, orphan medicines, and cases where the authority identifies safety risks or significant changes to an existing marketing authorisation. A standardised evaluation request form accompanies the guide.
- Submissions go to the Pharmacovigilance Department within the Directorate of Pharmacy
- Form H04 must accompany all RMP evaluation requests
What to do:
- If your Nicaragua portfolio includes in-scope product types, review the guide and confirm your RMP submission process aligns
- Use form H04 for upcoming evaluations
โFull Nicaragua PV requirements on RegIntelHub
Official source: MINSA RMP User Guideโ
Also this week:
๐ฒ๐ป Maldives โ The Ministry of Health issued a significantly revised Guideline on Pharmacovigilance and ADR Reporting this month, incorporating updated international standards.
โOfficial guideline | RegIntelHub Maldives pageโ
๐ช๐ฌ Egypt โ Version 4 of the EDA's Guideline for Good Regulatory Oversight of Clinical Trials entered into force on 26 March 2026.
โOfficial guideline | RegIntelHub Egypt pageโ
๐ฃ๏ธ Join the Conversation & Contribute
What did you think of this weekโs edition? Was it helpful?
Hit reply to share your thoughts or tell us if we missed an update.
โ
If this issue was useful, please share it with one PV colleague or join our growing Slack workspace to discuss these changes.
Until next week - stay compliant, stay curious.
โ๏ธ 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.
โ