The Changing Face of European Regulatory Affairs - Pharmaceutical Executive


The Changing Face of European Regulatory Affairs

Pharmaceutical Technology Europe

A complicated future

The European Medicines Agency has a challenging task; the EU continues to expand and the scope of the agency's activities needs to keep pace with these developments. The agency has acknowledged that with every wave of expansion in the EU, the integration of new national agencies into its network increases the complexity of operating an efficient European regulatory system. This was particularly the case in 2004 when 10 new member states joined the EU.4 Unlike most other regulatory agencies, the European Medicines Agency also has to deal with coordinating information in a range of different languages, which places considerable pressure on the agency's resources and makes it difficult to meet expectations. Many pharmaceutical companies are frustrated by the fragmented nature of the European market and are looking to the European Medicines Agency to introduce standardisation across the region. Equally, patients want to see quicker access to new medicines across the region. Many patient and consumer groups have been engaged in dialogue with the European Medicines Agency since its creation in 1995,5 but despite these issues, the European Medicines Agency also sees its changing role as an opportunity because it will be given greater responsibilities in the future. This will result in rapid expansion and give it greater prominence in international regulatory affairs.

The European Medicines Agency admits that since it operates on a networking model, its strength and efficiency will be determined by its weakest link. To identify and eliminate weaknesses, it has committed to publishing a plan every few years detailing its priorities and how it intends to achieve them.4,6 In 2004, the agency published an action plan to take it through to 2010.4 As part of this, the agency consulted with more than 65 stakeholders in a 3-month exercise. Comments from diverse parties, such as EU institutions, national health authorities, patient groups, pharmaceutical companies, trade associations, and academics, all influenced the final report. With respect to human medicines, the priorities to be achieved by 2010 included top-quality scientific assessment, timely access to safe and effective innovative medicines, continuous monitoring of medicinal products and improved access to medicines. As part of this, the European Medicines Agency also decided to benchmark its performance against that of other non-EU regulatory agencies.

In January 2010, the European Medicines Agency drafted its "Road Map to 2015", which represents an extension of the goals it sought to achieve with the 2010 version.6 The release of this document is set to be accompanied by public consultations, and comments from these will be used to publish a final version. In its 2010 document, the European Medicines Agency outlined how it intends to strengthen the partnership between all national EU regulatory authorities to improve its networking model. For 2015, it has extended this concept to include other EU institutions relevant to the regulatory environment, such as the European Centre for Disease Prevention and Control (ECDC). It has also placed greater emphasis on international cooperation, citing the confidentiality agreements it has signed with the US, Japanese, Canadian and Australian health agencies. Although the European Medicines Agency has always had an international outlook, this has become much more central to its plans for the future. The agency is currently developing a defined international strategy plan that will support the authorisation and supervision of medicines on a global scale.6

Another trend is improving the contribution from academics and scientific societies to the agency's work, as the European Medicines Agency would like to better support the development of regulatory science as a defined discipline. Similarly, integrating patient viewpoints into benefit/risk discussions is of interest to the agency because it would like to hear the views of those affected by its decisions.6 The agency still believes it can improve the process by which patients become involved in its activities.


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Source: Pharmaceutical Technology Europe,
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