Faiz Kermani
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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.
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.
Table 1: Authorisation of medicines in the EU
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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).
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
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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
