Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries)

Update to the guidance document “RMP ICH E2E Information submission HMP”

08.11.2023

The guidance document “RMP ICH E2E Information for submission HMP” has been fully revised.  The most important change concerns the obligation to submit RMPs, which now only applies to first authorisation applications for new active substances and their indication extensions.

There is no RMP obligation for known active substances without/with innovation or for biosimilars.

Other changes include clarifications regarding the submission of RMP updates and concerning the implementation of the RMP, as well as additional risk-minimisation measures.

The changes take effect on 1 November 2023.

Update to Guidance document "Information on PSUR / PBRER submission"

01.04.2022

The following points have been expanded on or clarified in section 5.2:

• PSURs are generally submitted once a year as a 12-month report. It is possible to modify the submission cycle (e.g. submission every 6 months, submission every 2 years).
• In future, modification of the reporting period will be via notification with brief supporting information (not an application as previously) by the marketing authorisation holder to riskmanagement@swissmedic.ch
• As a general rule, only one PSUR/PBRER document will be accepted per application.

Clarifications in section 5.4 regarding submission of RMP Updates have also been expanded on.

This guidance document enters into force on 1 April 2022 with a transitional period of 30 days.

Adaptation of guidance document “Drug Signals HMP”

21.01.2022

Shortened reporting time limits for signals from foreign authorities that are classified as emerging safety issues have been included in section 7.1.

The reporting time limit for these signals (e.g. “EU referral procedures for safety reasons: urgent EU procedures”) is 5 or 15 days respectively (Art. 62 para. 2 let. a TPO, Art. 62 para. 2 let. B TPO) for reporting the opening or conclusion of the signal/process.

A new subsection (7.1.1) includes explanations on the implementation of risk-minimising measures relating to signals from authorities.

The revised guidance document is valid with effect from 01.02.2022.

Update of the form «PSUR/ PBRER for human medicines HMV4»

20.01.2020

The «PSUR/ PBRER for human medicines HMV4» form has been updated.

Information on the latest approved ICH E2E / RMP documentation is now requested under «Supplementary documents submitted» and redundant administrative information has been removed from the form.

Safety signals for human medicinal products: change in the safety signal process following modification of medicinal product information as a risk minimisation measure, effective 1.01.2020

19.12.2019

As a new feature of the safety signal process, official decisions on the final wording for modified medicinal product information and/or packaging are already being issued after the signal has been evaluated. This means that once an official decision has been issued, marketing authorisation holders can submit the variation to Swissmedic within 30 calendar days as a C.I.1 a) type IA_IN application. Please note, however, that these applications for a variation cannot be submitted as part of a multiple application.

Modifying the safety signal process means that variations can be implemented faster.

The process in detail:
If medicinal product information has to be modified in the course of Swissmedic's evaluation of a signal, marketing authorisation holders will be sent the wording of the modified text by letter.

They will then have an opportunity to comment on the measures and the wording of the modification.

Unless marketing authorisation holders inform Swissmedic otherwise within the specified deadline, the Agency will assume that they consent. It will then issue its official decision on the text and complete the signal with that decision.

If marketing authorisation holders do inform Swissmedic otherwise, the Agency will review their reply and notify them of its decision by means of a preliminary decision.

Once the official decision on the wording has been issued, the modified medicinal product information and/or packaging texts must be submitted as a C.I.1 a) type IA_IN application.

Swissmedic can propose a general wording when extensive and complex modifications are required. In such cases, marketing authorisation holders should submit the final text plus their own comments as they deem necessary. After reviewing the proposed text, Swissmedic will notify marketing authorisation holders of the outcome of its review, including any text corrections, in the form of a preliminary decision.

An official decision on the final text will be issued once marketing authorisation holders have replied to the preliminary decision. A C.I.1 a) type IA_IN application should then be submitted within the specified deadline.

Section 11 of guidance document MU101_20_001e_WL Guidance document Drug Safety Signals HMV4 will be updated accordingly.

The new safety signal process will apply from 1 January 2020.