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EMA proposed changes to preparation of risk management plans.

A tendency towards more proactive risk management

In early 2016, the European Medicines Agency (EMA) started a major revision process of the good pharmacovigilance practice (GVP) Module V on risk management systems. Consequent to this, the Agency shared its intention to implement new modifications in the preparation of risk management plans (RMPs), in order to express the experience gained in the last few years. A public consultation was deemed necessary, which was aligned with a review of proposed updates to the current template for RMPs (last updated August 2013).

The consultation for the RMP template (first published February 2016) is now closed, and the revised template is soon due to come into effect. It is as yet not known whether all proposed changes will be followed; however, it is expected that the level of detail and complexity of RMP preparation may increase depending on specific situations.

The most important change that the EMA wishes to adopt is a redefinition of safety concerns: Important (identified and potential) risks and missing information. According to the proposed redefined terminology, there is more stress on causality as a leading factor for considering an undesirable outcome an important risk.

The newly revised definitions, as proposed, are as follows:

  • Identified risk: An undesirable outcome for which there is sufficient scientific evidence that it is caused by the medicinal product.
  • Potential risk: An undesirable outcome for which there is a scientific basis for supposition of a causal relation with the medicinal product (e.g. a signal, a class effect plausible also for the new product, findings from (non-) clinical studies) but where there is insufficient support to conclude there is a causal association.
  • Missing information: Gaps in knowledge about a medicinal product, related to the anticipated utilization patterns such as long term use or use in particular patient populations, which could be clinically significant.

In the draft RMP template, there are further major differences in how specific sections need to be addressed according to the type of application of the product. As opposed to the current procedures, the RMP complexity will probably increase for those generic products where there is no RMP available for the reference medicinal product. In this case, for the risks included in the list of safety concerns of the product(s), the scientific evidence that has led to the inclusion should be discussed, and further details on the safety concerns should be provided in section “Details of important identified and important potential risks” (Part II.SVII.3).

On the other hand, it is expected that the amount of data to be provided in the RMP will decrease for those products approved through hybrid, well-established use or fixed combination medicinal products which do not contain a new active substance (Part II. S.I.-S.VII. may be omitted).

Regarding the pharmacovigilance plan (Part III.1), only a brief description of the routine pharmacovigilance activities beyond ADRs reporting and signal detection may need to be included within “Routine pharmacovigilance activities” section. Additional pharmacovigilance activities (e.g. post-authorization safety studies) are proposed to be addressed in a different section (Part III.2). The same is applicable for additional risk minimization measures (healthcare professional and patient/care guides, prescriber checklist, patient reminder card etc.), as the new approach is to describe these in a dedicated section in Part V.

Some other administrative changes have been proposed in the draft, such as the need to include in the prepared RMP links to specific documents in the eCTD sequence.

Throughout the whole document, there is a focus on the fact that the RMP should be updated to reflect the knowledge and understanding continuously gained following the use of the product.

According to the EMA statement, the overall purpose of the revision process is to simplify the way companies present risk management information to regulators and aim at providing risk-proportionate, fit for purpose RMPs.

In the light of the ever evolving world of pharmacovigilance, marketing authorization holders should be aware of current demands and be ready to adhere to the new changes once they are finalized.


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