According to the European Medicines Agency (EMA) requirements, pharmaceutical companies should provide a risk management plan (RMP) when they apply for a marketing authorization. To simplify this task, EMA has published a guidance on how to develop RMPs in 2012 along with the RMP template.
Therefore, RMPs must contain the following information:
- safety profile of the drug;
- how potential risks for patients associated with this drug will be prevented or mitigated;
- strategies for further trials or other activities with the aim of getting more information on safety and efficacy profiles of this drug;
- how to measure the usefulness of measures taken to minimize potential risks.
In accordance with the European Union requirements, pharmaceutical companies must provide a risk management plan at the same time as applying for marketing authorization. However, if the drug does not have a RMP, the authority may require submitting it when a market authorization holder will apply for adding significant alterations in the marketing authorization. Moreover, if the medicinal product is nationally authorized a national competent authority in the European Union may make a query and demand RMP in case a concern regarding the benefit-risk balance for this drug arises.
EMA issued the second version of the RMP template on 30 March 2017. Marketing authorization holders and applicants may use this template for submitting RMPs since 31 March 2017. However, all marketing authorization holders and applicants are obligated to use it since 31 March 2018.
“Rules of good pharmacovigilance practice of Eurasian European Union” approved by the Decision of the Board of Eurasian European Committee dated 03 Nov 2016 # 87, assumes the use of the RMP template that is maximally harmonized with EMA RMP template issued in 2012.
At the same time, EMA has published the second version of RMP template in 2017 that is substantially different from the version issued in 2012, and corresponding recommendations, that marketing authorization holders and applicants could use when submitting the RMP since 31 Mar 2018, yet, it was on the applicant’s discretion whether to use the old or the new template.
Since 31 Mar 2018, the use of the new RMP template for EU submissions became mandatory, and this creates additional complications for the companies that submit both in EU and EAEU, as substantially different templates are to be used in corresponding regions.