The European Medicines Agency (EMA) has released draft versions of the latest revisions to Module XVI of its good pharmacovigilance practice (GVP) guidelines for public consultation.
The modifications to “Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators” include changes to existing sections, the addition of three new sections and the removal of an appendix which has been integrated into Addendum II instead.
The new sections cover the criteria for requiring additional risk minimisation measures, the role of risk communication, dissemination and implementation as a relevant part of any additional risk minimisation activity, and recommendations on the additional risk minimisation measures within the lifecycle of a product.
The modified sections include clarifications on the role of risk minimisation for risk management planning and for the impact on the risk-benefit balance of medicinal products, additional guidance on risk minimisation evaluation parameters and the criteria and methods for risk minimisation evaluation, and more details on the role of healthcare professionals and patients in risk minimisation development, dissemination and evaluation.
“Addendum II – methods for effectiveness evaluation” details how to assess the outcomes of risk minimisation measures through guidance on data sources, research methodologies and reporting results. Consequently, the EMA decided that Appendix I on survey methodologies should be integrated into Addendum II of Module XVI.
The deadline for comments on the revised module is 28 April 2021, after which the EMA anticipates that the finalised version will come into effect by Q4 2021/Q1 2022.
To view the revised Module XVI in full, click here.
To view the revised Addendum II in full, click here.