Analysis of Errors Identified during Regulatory Review of Risk Management Plans Submitted as Part of Registration Dossiers

Abstract

Scientific relevance. On 6 December 2022, an updated version of the Rules for Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP) came into force. The greatest changes were made to the requirements for pharmacovigilance documents, particularly the risk management plan (RMP). In practice, the changed EAEU GVP has resulted in multiple errors, creating the need to thoroughly analyse their structure and causes and to develop recommendations for their prevention.Aim. This study aimed to identify, analyse, and collate inconsistencies between the information submitted by marketing authorisation holders in their RPMs and the updated EAEU GVP requirements.Materials and methods. The Scientific Centre for Expert Evaluation of Medicinal Products analysed 50 RMPs received after 6 December 2022 as part of registration dossiers aimed to support marketing authorisation applications and/or align the registration dossiers with the EAEU requirements.Results. The errors made by applicants when preparing RMPs were categorised according to their influence on the interpretation of a medicinal product’s safety profile. The errors leading to incorrect safety profile interpretations were considered type 1 errors (63% of the cases). The errors affecting the perception of the RMP but not the interpretation of the safety profile (e.g., grammatical errors, notes and comments by applicants, incorrect translation of terms) were deemed type 2 errors (37% of the cases). The majority of EAEU GVP noncompliance cases were detected in Part II of the RMP, the section providing the most information on the safety profile of a medicinal product.Conclusions. There are several ways to improve the quality of RMP preparation. The information included in the RMP should be compared with the information provided in the registration dossier. The RMP should be incorporated into the integrated pharmaceutical quality system according to the requirements of good practices.A responsible employee of the marketing authorisation holder’s quality assurance system should control the final RMP version. Employees of pharmacovigilance departments should receive regular training.

Keywords

• risk management plan
• authorisation of medicines
• rules of good pharmacovigilance practice
• gvp
• pharmacovigilance
• drug safety
• eurasian economic union
• marketing authorisation holder
• drug safety profile