[co-author: Silvia López Arnao]

The European Medicines Agency (“EMA”) has announced its intention to update the Agency’s existing guidance concerning additional risk minimisation measures (“aRMMs”). The revised version will provide extensive guidance on various tools for additional risk minimization. Some of these were already mentioned in the current version of the guidance. Others will be introduced by the revised version. The new version of the guidance is expected to be released for stakeholder consultation by the end of 2020 or early 2021.

The European Medicines Agency (“EMA”) has announced its intention to update the Agency’s existing guidance concerning additional risk minimisation measures (“aRMMs”). The new version of the document is expected to be released for stakeholder consultation by the end of 2020 or early 2021.

Current framework

The current EMA’s guidance on risk minimisation measures is provided in Module XVI of the EMA’s Guideline on good pharmacovigilance practices. The most recent version of this guidance was issued on 28 March 2017. EMA’s attempts to update this version were suspended to ease the EMA’s relocation to Amsterdam due to Brexit. In October 2019, the EMA’s revision work was resumed.

The current version of the EMA’s guidance provides that routine risk minimisation measures, such as labelling and summary of product characteristics, are applied to every medicinal product. When routine measures are not sufficient to manage the risk and/or improve the medicinal product’s benefit-risk balance, aRRMs are required. However, the current version of the guidance provides only a short summary of these additional measures.

Proposed changes concerning additional risk minimisation tools

The new guideline is intended to provide a detailed description of various additional risk minimisation tools that companies can use to address safety issues concerning their medicinal products. Some of these were already mentioned in the current version of the guidance, and others will be introduced by the revised version.

• Guides. The EMA has decided that all educational tools referred to in the current version of the guidance will be called “guides”, to avoid confusion with other tools such as patient leaflets. The updated guidance will outline the intended objectives of such guides.
• Checklists for health professionals. The revised guidance will provide new information on this tool, that was already mentioned in the current version.
• Risk awareness forms. This tool may be used to inform the patient about the risks related to a medicinal product in order to document that this discussion has occurred. However, the EMA warns that they do not constitute a shift in responsibility to the patient.
• Demonstration kits. These include dummy inhalers or injectors that can be used to train the patient in complex administrations.
• Patient diaries. Although these diaries are commonly used in clinical practice, the EMA considers that they can also constitute a risk minimisation tool.
• Patient cards. The current version of the guideline refers to these by different names, such as alert cards, patient reminder cards, and risk minimisation cards. The revised guidance will provide advice on the possibility of having these patient cards inside the product pack, affixed onto the pack or as a standalone.

Other proposed changes

The EMA has announced that the revised guidance will also include the following changes:

• The inclusion of a specific section concerning the re-evaluation of the necessity for aRRMs. This section will provide guidance on how companies must keep their risk management plans updated. The results of the re-evaluation may lead to the withdrawal of an existing tool, the substitution of one tool for another, or the modification of the target audience of the tool.
• The revision of the sections concerning pregnancy prevention program and controlled access.
• The simplification of the section on direct health care professional communication.

The EMA has clarified that the revised guidance will not provide changes in the way the effectiveness of aRMMs is measured. Companies will, therefore, continue to be required to propose an evaluation method.

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