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The Changing Face of European Regulatory Affairs


Pharmaceutical Executive

In 1995, pharmaceutical regulation in Europe underwent a dramatic change with the emergence of the European Medicines Agency. The agency's 15-year history has been eventful, with it having to adapt to a changing regulatory landscape and new expectations from those relying on it for guidance.

An important point to understand is that the European Medicines Agency is not supposed to be a European equivalent to the FDA, although the two agencies do enjoy a high level of cooperation.1 The European Medicines Agency has a unique set-up because the EU regulatory system combines national viewpoints with regional viewpoints, which means that it works with national competent authorities in individual EU member states, as well as the EEA-EFTA states (Iceland, Liechtenstein and Norway). In effect, the European Medicines Agency is almost a virtual entity in that it works as an interface between different national agencies, enabling coordination of regulations across Europe as a whole.1 To achieve this, the national agencies agreed to pool their sovereignty for the authorisation of medicines and use the European Medicines Agency as a forum for achieving consensus.

Faiz Kermani

At present, the European Medicines Agency works with a network of 40 national competent authorities in 30 EU and EEA-EFTA countries, involving more than 4500 European experts.1 The main scientific work of the agency is coordinated through six scientific committees, which feature members from all EU and EEA-EFTA states, with some including patients' and doctors' representatives.2 Although further improvements can still be made, there can be no doubt that the European Medicines Agency has helped improve regulatory harmonisation across Europe and beyond.

A lengthy start

Most people tend to think of the launch of the European Medicines Agency as representing the start of European regulatory harmonisation. However, initiatives to achieve this started much earlier, defining elements that are now well known features within the European Medicines Agency set-up. In 1965, a European directive laid the foundations for authorising medicinal products for human use.1 In 1975, a second directive covered technical principles and outlined the creation of a scientific committee for medicinal products for human use.1 The origins of the Committee for Medicinal Products for Human Use (CHMP), which represents the agency's opinions on all questions concerning medicines, lie in this directive. In 1985, a European single market project was launched and by 1993 the foundation of the European Medicines Agency as an organization was well on its way with a formal regulatory system having been described.1 This sequence of Directives allowed the agency to launch in 1995 and introduce its centralised and decentralised approval procedures.

The EU regulatory system now covers three main activities in relation to medicines regulation: scientific assessment, monitoring of authorised medicines and harmonisation of the technical requirements for the evaluation and supervision of medicines. While the system still allows for different licensing routes for human (and veterinary) medicines — sometimes because of regulatory circumstances that pre-date the formation of the European Medicines Agency — there has been a move to reduce some of these options by extending the scope of the centralised procedure (Table 1).

Table 1: Authorisation of medicines in the EU

A distracting issue for the agency following its launch was confusion over its former corporate acronym — EMEA. Originally, EMEA stood for the European Agency for the Evaluation of Medicinal Products, but over time the agency dropped this lengthy title to become known simply as the European Medicines Agency. A number of stakeholders and partners expressed dissatisfaction with the acronym — the main comments being that the second 'E' did not quite match the full agency name and that EMEA was also a term used in the business community to refer to Europe, Middle East and Africa.3

While the acronym issue might be considered a trivial issue to some observers, the agency is concerned that confusion over names will lead to misunderstandings over the agency's role and set-up.3 As of 2010, the agency is attempting to move beyond this issue by using its full title in corporate material, although it has recognised that it cannot use this approach for its website and email addresses, which now incorporate the EMA acronym following the launch of a new corporate identity programme in December 2009.3 However, the agency has stated that it is not averse to considering the EMA acronym in the future, if this evolves naturally as an accepted acronym.3

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.


The European Medicines Agency is unique among global regulatory agencies because it operates on a networking model and because its area of geographic influence does not remain static. While this would appear to create numerous difficulties for the agency, it appears confident about its future and is already planning to extend its activities. Its expanding European responsibilities and wide range of contacts through its networking arrangements should tie in well with its desire to become a stronger force in international regulatory affairs.

Faiz Kermani is a freelance consultant and President of the Global Health Education Foundation, a charity that supports medical education and medical research projects in development countries. He is a member of Pharmaceutical Technology Europe's Editorial Advisory Board. faiz@doctors.org.uk


1. P. Le Courtois, Introduction to the EMEA (1st EMEA Workshop with Patient Organisations, 2002). www.emea.europa.eu

2. EMA, "About Us — Structure" (2010). www.ema.europa.eu

3. EMA, "New visual identity, web/e-mail addresses and organisation chart of the European Medicines Agency" (2009). www.ema.europa.eu

4. EMA, "The European Medicines Agency Road Map to 2010" (2004). www.ema.europa.eu

5. EMA, "EMEA and patients' and consumers' organisations" (2009). www.ema.europa.eu

6. EMA, "The European Medicines Agency Road Map to 2015: The Agency's Contribution to Science, Medicines, Health. Draft for Public Consultation" (2010). www.ema.europa.eu