Pharmacovigilance – Guidance on EU Risk Management Plans

In the EU, a Risk Management Plan (RMP) should be submitted as part of a Marketing Authorisation Application by the Marketing Authorisation Applicant (MAA). It should also be submitted for marketed products by the Marketing Authorisation Holder (MAH) in case of major updates affecting the benefit-risk balance or by request from EMA or a national competent authority.

In early 2017, EMA updated its guidance on how to write RMPs. This guidance is now fully implemented and all new and updated RMPs must be written in accordance with this new format.

So what are the implications? Can’t we just move the content a little around?

The short answer to this is “No”. Even though the changes at first sight seem to be insignificant they represent a new mindset that warrants less data dump and more thinking.

After having now helped several customers writing both initial and updated versions in the new template, I can only stress that it is not easy! If at all possible, start the work on the RMP very early to allow for all the thought processes and review rounds that are necessary, even in situations where you already know your product inside and out and have written one or more RMPs in the old format.

The first template released by EMA, seemed to foster a “better safe than sorry approach” meaning that the MAHs and MAAs would tend to list everything they could consider as important risks and missing information, and there seemed to be a mantra that once a risk was put into the RMP it could never be removed, which could make the documents rather voluminous after several updated versions.

All of this has changed. Now EMA insists that the risks that are listed requires managing. If a risk is already known and managed by the healthcare professionals and the patients themselves, and there is no further risk minimisation possible, there is no point in listing this in the RMP and it should be described why it is not considered a risk. Likewise, the risks that are included in the RMP should be there for a reason, and the rationale for listing them as significant risks needs to be provided.

It is no secret that I like the new format. I think it is a big step forward in keeping the MAHs /MAAs focused on their tasks; ensuring that the medicines that are put and kept on the market are as safe as at all possible to the benefit of us all. At the same time, there are some indications that the template as released by the EMA is not necessarily all thought through. Some naming of tables and sections are a bit inconsistent and the guidance text is somewhat contradictory from time to time. Again, start the work early, to ensure the mindset of the guidance is adhered to and you do not get side-tracked by these small annoyances.