Post-registration security studies

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The company ANO NSC Pharmacovigilance provides such a service as conducting post-registration studies of the safety of medicines.

According to the rules of Good Practice of the EAEU Pharmacovigilance, a post-registration safety study (PRSS) is a study conducted to determine, characterize or quantify a security threat, confirm the safety profile of a medicinal product or evaluate the effectiveness of risk management measures. The possible risks of special, specific populations of patients are also analyzed during the procedure. A post-registration safety study can have both an interventional and non-interventional design.

The documents prepared by us comply with the principles of Good Pharmacovigilance Practice, as well as the regulatory requirements of state authorities.

Purpose

One of the most important goals of the PRSS is to assess the benefit-risk ratio of the use of the drug.

Post-registration supervision

In Russia, since 2010, medicines have been subject to safety monitoring in accordance with Federal Law No. 61-FZ of 12.04.2010 «On
circulation of medicines» (Article 64), Order of Roszdravnadzor No. 1071 of 15.02.2017 «On approval of the procedure for pharmacovigilance» and Order of the Ministry of Health and Social Development of 26.08.2010 No. 757n.

«Subjects of circulation of medicines are obliged to report in accordance with the procedure established by the authorized federal executive authority
in the order about all cases of side effects not specified in the instructions for the use of the drug, about serious adverse reactions, unforeseen adverse reactions when using drugs, about the features of the interaction of drugs with other drugs that were identified during clinical trials and the use of drugs.»

After receiving the decision of the authorized bodies on the appointment of the PRSS,
the holder of the registration certificate develops a Research Protocol and submits it to the authorized body for consideration. Within 60 calendar days from the date of submission of the draft Protocol, the authorized body draws up a response in the form • of approval of the draft Protocol of the study;
• recommendations for making changes to the Study Protocol;
• refusal to approve the Research Protocol;
• notifying the RU holder that the study is a clinical trial subject
to the requirements of the Rules of Good Clinical Practice and relevant local legal requirements.