For each new active substance in CTIS, a so-called Safety Assessing Member State (SaMS) is appointed to assess the submitted safety information.
The SaMS will carry out the assessments for all investigational medicinal products containing the same active substance, regardless of the pharmaceutical form, strength, or indication being investigated, and regardless of whether they are used in different trials of different sponsors. This means that a Member State can be the SaMS for a trial containing a specific active substance, regardless of whether the Member State received the application as a Member State concerned or not.
The SaMS will share the assessment with all Member States concerned. If necessary, after screening the reported safety information, the SaMS will contact the sponsor for additional information. The SaMS may recommend corrective actions or other risk mitigation measures to the Reporting Member State and Member States Concerned in accordance with Article 77 of the CTR.
There is an Implementing Regulation on the establishment of rules and procedures for the cooperation of Member States regarding the safety assessment of drug studies. Only a Member State will be designated to assess the safety of an active substance for which medicinal product studies are being conducted in more than one involved Member State. For active ingredients used in only one medicinal product study in one involved Member State, that Member State is responsible for the safety assessment. Auxiliary medicinal products, authorized comparators, and placebos fall outside the scope of this Implementing Regulation. Therefore, no SaMS will be assigned for these.