Pharmacovigilance: Overview

2024-07-17 12:32| 来源: 网络整理| 查看: 265

In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and published a second revision in April 2022:

PRAC strategy on measuring the impact of pharmacovigilance activities

AdoptedReference Number: EMA/590673/2020 Rev.2Summary:

Pharmacovigilance activities contribute to the protection and promotion of public health through preventing harm caused by medicines as well as by enabling the safe and effective use of medicines.

English (EN) (525.98 KB - PDF)

First published: 19/04/2022View

Also know as the PRAC impact strategy, it aims to shift the focus of pharmacovigilance towards the activities and regulatory tools that are most relevant to patients and make the greatest difference in daily healthcare.

The latest revision highlights the achievements attained since the strategy's launch, in its four key activity areas:

effectiveness evaluation of risk-minimisation measures;effectiveness of pharmacovigilance processes;enablers of effective pharmacovigilance and stakeholder engagement;analytical methods for impact research.

The revised strategy also includes:

• new information on how to prioritise and carry out impact research;• a review of industry-sponsored post-authorisation safety studies evaluating the effectiveness of risk-minimisation measures.

The strategy follows a 2016 stakeholder workshop on measuring the impact of pharmacovigilance activities. For more information, see:

Report - Workshop on measuring the impact of pharmacovigilance activities

Reference Number: EMA/59474/2017

English (EN) (353.84 KB - PDF)

First published: 27/03/2017Last updated: 27/03/2017View

The PRAC has published a checklist with criteria to prioritise collaborative impact research for identifying and selecting safety topics discussed at the PRAC which require the generation of data to monitor the impact of regulatory interventions:

Checklist for prioritisation of EU regulatory network collaborative impact research

Reference Number: EMA/318043/2017

English (EN) (203.78 KB - PDF)

First published: 26/06/2017Last updated: 26/06/2017ViewResearch projects

EMA has contracted several institutions to conduct research projects collecting and analysing real-world data from clinical practice. This helps monitor the safety and effectiveness of medicines.

Alternatively, national competent authorities - as members of the European medicines regulatory network (EMRN) - may conduct research collaboratively.

The document below includes information on:

Research frameworkSafety concern(s)Risk minimisation measures (RMM)Regulatory procedure for RMM implementationStudy objectivesPublication of the results

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