Uzbekistan PSUR and RMP Requirements: Periodic Safety Documentation Guide

1. Key takeaways

Registration No. 3752 requires two categories of periodic documents. The first is the periodic safety update report (PSUR), which must reflect adverse events identified abroad and be prepared in accordance with the national GVP standard. The second is the risk management plan (RMP), which must cover identified risks, potential risks, missing information, and risk minimization measures. The format of the PSUR follows international standards, so companies that already operate PSUR processes for European Union or ICH markets can align with it directly; what still needs local adaptation is the submission timing and the local formatting requirements, and those details should be confirmed with the local representative rather than assumed. Neither document substitutes the other, and the authority expects both to be maintained throughout the life of the certificate. Because both documents draw on the same underlying safety data, keeping them consistent is mostly a matter of governance: one benefit-risk conclusion, expressed once and referenced by both.

2. Legal basis

3. Expert insights

Insight 1: The PSUR and the RMP occupy different positions in the documentation system. The PSUR is a periodic, retrospective document that answers what the safety data over the reporting period shows; the RMP is a forward-looking document that answers how identified and potential risks are to be minimized. The two documents share the same set of benefit-risk assessment conclusions, but they look at it from opposite directions: the PSUR looks backward at what has happened, while the RMP looks forward at what must be prevented or mitigated before it happens. Presenting both documents in this order also helps internal reviewers, who otherwise tend to repeat the same risk discussion twice, once looking backward and once looking forward.

Insight 2: The PSUR must connect with the risk management documents submitted at registration. Item 2.7 of Resolution No. 738 requires a risk management and analysis report, and Item 2.15 requires a post-market plan for the collection and analysis of safety and effectiveness data. The post-market PSUR and RMP should connect with these two registration documents: the residual risks identified at the registration stage are precisely the core content of the RMP and the priority observation objects of the PSUR. A disconnect between the registration file and the post-market file is one of the first things a reviewer will notice. Mapping each residual risk from the registration file to a section of the RMP and a line of the PSUR makes the connection auditable rather than asserted.

Insight 3: The RMP requirement does not prescribe a format, but the obligation itself is explicit. Registration No. 3752 does not specify the exact format of the RMP, but it clearly requires that the plan exist and be maintained. When preparing the document, companies should cover the four elements: identified risks, potential risks, missing information, and risk minimization measures. This is the internationally accepted skeleton of an RMP, and it is also the structure that reviewers expect to find, so deviating from it creates avoidable friction without any benefit. A company can therefore reuse the RMP structure already maintained for other markets and adjust only the market-specific sections, provided the four elements remain visible.

Insight 4: The local adaptation points of the PSUR are timing and format, not methodology. Since the PSUR format follows international standards and the national GVP standard is coordinated with them, companies that already produce PSURs for the European Union or ICH markets can reuse their methodology wholesale. What needs local adaptation is the submission timing and formatting details, and these should be confirmed with the local representative before the first submission cycle, rather than copied from an existing process that was designed for a different regulator. The first submission is the right moment to fix the template, because later cycles inherit whatever structure the first cycle established.

4. Practical recommendations

1. Manage the PSUR and the RMP as two separate documents, with the PSUR oriented to retrospective review and the RMP oriented to forward-looking risk control.
2. Prepare the RMP along the four elements: identified risks, potential risks, missing information, and risk minimization measures.
3. Connect the post-market PSUR and RMP with the Item 2.7 and Item 2.15 documents submitted at the registration stage.
4. Reuse the PSUR methodology from European Union or ICH markets, and confirm the submission timing and formatting details with the local representative.
5. Establish an annual review mechanism for the RMP, updating it promptly whenever the benefit-risk conclusions change; updates should be versioned so that the history of conclusions remains traceable.

5. Verification checklist

• □ The PSUR and the RMP are managed as two separate documents
• □ The RMP covers identified risks, potential risks, missing information, and risk minimization measures
• □ The PSUR includes adverse events identified abroad
• □ The post-market PSUR and RMP are connected with the Item 2.7 and Item 2.15 registration documents
• □ The submission timing and formatting details of the PSUR have been confirmed with the representative
• □ An annual review mechanism for the RMP has been established

Regulatory information verified as of October 29, 2026.

GRZAN provides regulatory support to manufacturers, importers, and authorized representatives seeking medical device registration and post-market compliance in Uzbekistan, including dossier preparation, authorized representative arrangements, vigilance setup, and surveillance readiness. For inquiries, contact info@grzanglobal.com.