Update to Guidance Document: Risk Management Plan (RMP) ICH E2E Information for HMP Submission

On 15 February 2022 the Swissmedic announced the updated guidance on RMP ICH E2E submission information for human medicinal products.

Based on established common practice, clarifications on the obligation to submit an RMP in connection with applications for authorization have been added to section 6.

Experience has shown that RMP updates were also being submitted to Swissmedic for review when no relevant content changes had been made. In light of this, the RMP update submission requirements in section 7.1 and its subsections have been clarified and/or redefined.

The “Switzerland-specific Annex (SSA)” on RMP has been newly included. This substantiates and presents any deviations as regards safety concerns or implementation of pharmacovigilance activities or risk-minimizing measures in Switzerland relating to the RMP submitted (usually EU RMP).

Submission of study results from the pharmacovigilance plan, of educational materials and of RMP summaries have been addressed in sections 9 and 10.

The revised guidance document is valid effective 1 March 2022.

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