The European Medicines Agency(EMA) is set to implement the new European Union (EU) legislation on pharmacovigilance. The new legislation aims to promote and protect public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines.
The new pharmacovigilance legislation will help EMA to make the system more robust for public health and more transparent. It gives regulators a range of improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines. It also increases the efficiency of medicines regulation for the benefit of all stakeholders.
The major focus areas of the new legislation on pharmacovigilance include the establishment of a new scientific committee and the Pharmacovigilance Risk Assessment Committee (PRAC). There is a clarification of the roles and responsibilities of all actors involved in the monitoring of the safety and efficacy of medicines in Europe and strengthened coordination, leading to more robust and rapid EU decision-making. It will help to engage with the patients and healthcare professionals in the regulatory process, including direct consumer reporting of suspected adverse drug events. There is improved collection of key information on medicines, like for instance through risk-proportionate, mandatory post-authorization safety and efficacy studies.
Further the legislation increases more transparency and better communication, including publication of agendas and minutes of the PRAC and the possibility to hold public hearings.
“The progress made in healthcare would not have been possible without medicines and the research and development community behind them. But we need an efficient regulation for the system to be able to continue to deliver safe and effective medicines,” said Guido Rasi, executive director, EMA.
The new legislation was proposed by the European Commission in 2008 and adopted by the European Parliament and the Member States in December 2010.
The Agency is ready for the first meeting of the PRAC on July 19 and 20. All Member States have nominated their members. The European Commission has appointed six independent scientific experts who will also serve as members. The nomination of PRAC members representing patients and healthcare professionals will follow a new public call for expressions of interest.
A section of the pharma industry and the clinical research organizations in India have appreciated the initiative and they stated that the new legislation is the base for other countries to follow.