Safety assessing MS

On basis of article 44 of the CTR, an implementing regulation has been published laying down the rules for the cooperation between Member States in the assessment of information and reports submitted under Articles 42 (SUSARs) and 43 (annual safety report, ASR) of the CTR.

The coordinated assessment of SUSARs and ASR is led by a safety assessing MS (saMS) for multi-national active substances. For mononational active substances, the RMS is responsible for the assessments of SUSARs and ASRs.

In case an originally mono-national active substance becomes a multi-national active substance, for example through the extension of the clinical trial to another Member State or where another Member State has authorised a clinical trial that involves the same active substance, a saMS will be appointed for the coordinated safety assessment.

In the Netherlands, the role of saMS is a task of the CCMO – national clinical trial office ('Landelijk Bureau').