GVP: EMA consults on revised risk minimization module
The European Medicines Agency (EMA) on Wednesday released draft versions of the third revision to its good pharmacovigilance practice (GVP) module XVI guideline on risk minimization measures and its second addendum to the guideline on methods for evaluating the effectiveness of risk minimization measures for public consultation.The deadline to comment on the documents is 28 April 2021 and EMA says it expects the revised guideline and new addendum to come into effect in late 2021 or early 2022. The current versions of the guideline came into effect since March 2017.
EMA explains that, “Together, these two GVP documents are meant to clarify and enhance tools for risk minimisation measures and strengthen methods for studying the effectiveness of the implementation of risk minimisation measures and the possible need for adjustments of risk minimisation measures in the interest of patient safety.”
Revisions to the 30-page GVP guideline Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators include changes to several sections, the addition of three new sections and the deletion of an appendix on survey methodologies, the latter of which has been integrated into Addendum II of the module.
The updated sections now include clarifications about the role of risk minimization for risk management planning and the impact on the risk-benefit balance of medicinal products; a fleshed-out discussion of controlled access systems; expanded guidance on criteria and methods for risk minimization evaluation; additional guidance study designs and data collection methods; and strategies for early engagement with healthcare professionals and patients in risk minimization development, dissemination and evaluation.
The three new sections include guidance on applying and requesting additional risk minimization measures, the role of risk communication, dissemination and implementation and the addition of risk minimization measures within the lifecycle of product.
The 15-page draft addendum provides expanded guidance for marketing authorization holders and regulators on data sources and methodologies for monitoring the outcomes of risk minimization measures.
EMA