The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission’s 2010 amended pharmacovigilance legislation.
The concept paper details several topics including:
- pharmacovigilance system master files
- the quality system for the performance of pharmacovigilance activities
- the use of internationally agreed terminology, formats, and standards
- monitoring data in the EudraVigilance database
- the electronic transmission of suspected adverse reactions
- electronic periodic safety update reports and risk-management plans
- postauthorization safety studies.
According to the concept paper, these measures will supplement essential aspects of the new pharmacovigilance system with the more technical details that must be observed by marketing authorization holders, national competent authorities, and EMA in the daily practice of applying the new legislation. “It is therefore important that they are fit for purpose and strike the necessary balance between the fundamental objective of the current legislative framework for medicinal products, i.e. to safeguard public health, and general internal market requirements,” explains the concept paper.
The new legislation was formalized last year (Directive 2010/84/EU amending Directive 2001/83/EC, and Regulation (EU) No. 1235/2010 amending Regulation (EC) No 726/2004). According to an implementation plan, most of the provisions will come into force by the end of July 2012.
“This new public health legislation is far reaching in scope and in depth and goes far beyond any narrow concept of pharmacovigilance,” said the EMA in the implementations plan. “The legislation strengthens safety monitoring, [rationalizes] reporting and increases the use of studies including pharmacoepidemiology, makes clear roles and responsibilities, sets out decision-making, increases participation, reinforces transparency and strengthens the action that can be taken to protect and promote public health.”
The paper describes the scope and content of the implementing measures and will be available for consultation until Nov. 7, 2011. The Commission is seeking the views of all stakeholders, and details on how to participate are available on the EMA website.