The changing face of European regulatory affairs - Pharmaceutical Technology

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The changing face of European regulatory affairs


Pharmaceutical Technology Europe
Volume 4, Issue 22


Faiz Kermani
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
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




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


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