Post-authorisation safety study

A Post-Authorisation Safety Study (PASS) of a medicinal product may be initiated, monitored, or sponsored by the market authorization holder voluntarily or under an obligation imposed on it by an authorized body as a condition of issuing a market authorization or after issuing market authorization, if there is an assumption of risks associated with a registered medicinal product that require further investigation through clinical study.

The objectives of the post-authorisation safety study are:

  • quantification of potential or identified risks, as well as the study of risk factors and factors modifying the effect of the drug product;
  • assessment of the risks of a drug used for an approved indication in groups of patients who have not been studied or have been insufficiently studied at the pre-registration stage;
  • assessment of the risks associated with long-term use of the drug;
  • confirmation that there are no risks associated with the use of the drug;
  • evaluation of standard clinical practice for prescribing medications;
  • assessment of the effectiveness of risk minimization measures.

The X7 Research team has extensive experience in conducting non-interventional studies in Russia, EAEU, CIS, EU. We work by the latest legal requirements in the field of drug circulation.

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