The EMA And EU Expansion

In addition to coordinating centralised authorisation procedures for medicines, the EMA is responsible for a number of other tasks, and must rely heavily on the involvement of the EU member states and the countries of the European Economic Area. The greatest challenge faced by the agency, however, is the continuing expansion of the EU.
Jun 01, 2011

The EMA has extensive obligations in Europe, including issuing scientific opinions in support of EU-wide marketing authorisations, offering advice on medicine-related issues, and working with institutions and partner agencies on major European public-health issues. The agency works closely with the EU's 27 member states, as well as the European Economic Area (EEA) countries of Norway, Iceland and Liechtenstein, and relies on these countries to maintain regulatory standards in Europe on its behalf. Unlike the FDA in the US, the EMA itself does not carry out day-to-day operational matters itself. Representatives of the member states serve as members of the EMA's management board, and the EMA's six scientific committees and network of 4500 scientific experts are also nominated by the member states.

From the pharma industry's point of view, the most high-profile role for the EMA is coordinating the centralised authorisation procedure for medicines, which results in a single marketing authorisation that is valid in all member states and EEA countries. This regulatory procedure is compulsory for biotech medicines, which represent a growing percentage of the drug output of major companies. Applications for the centralised procedure are submitted directly to the EMA where they are evaluated by scientific committees. After this, the committee adopts an opinion on whether the medicine should be marketed or not—a process that can take up to 210 days. The opinion is then sent to the EC, which is the ultimate body for granting marketing authorisations in the EU. This last process is almost a formality; no opinion has ever been overturned by the EC. Once the marketing authorisation has been granted, a company can begin to market the product across the EU.

Adapting to EU expansion

Table I: EU expansion.
One of the challenges for the EMA in coordinating the centralised procedure is that the EU has expanded considerably since its inception in 1995 (see Table I). Therefore, the EMA has had to bear in mind that its decisions have a wider impact on an ever-increasing population of patients. Creating a robust regulatory system for the EU was never considered a straightforward task, but the EMA has faced the additional challenge of a growing number of regulatory partners to interact with and oversee. As its remit widens to taken on new European countries, the agency must also rely on regulatory bodies in entrant countries for operational matters. While there is an expectation that these bodies will work to the same standards as more long-standing members, they will inevitably lack the same level of experience.

The EU has always been characterised by expansion and the political drive to pursue this strategy continues to have a knock-on effect on the EMA's workload. However, the EMA has become adept at planning in advance for future expansion, particularly since May 2004 when the EU expanded to take in 10 new countries with a combined population of almost 75 million (1,2). It was around this time that the agency's founding legislation was also changed to reflect its expanding role with Regulation (EC) No 726/2004 replacing Regulation (EEC) No 2309/93 (3).

After the signing of their respective accession treaties, the national authorities of the candidate countries were invited to send observers to the EMA's scientific committees and working parties, with effect from April 2003 (4). As well as ensuring that the national agencies of entrant countries became familiarised with EMA processes and standards, preparations also had to be made for the translation of EMA documents into new languages. During 2003, the agency's website was updated with an estimated 10000 new documents (4). The EMA was also tasked with ensuring that the new regulatory authorities were linked to EudraNet (the European Telecommunication Network in Pharmaceuticals), an IT platform that enables scientific experts, policy makers and other designated staff to have a secure electronic environment to exchange and share information on a pan-European basis (5). There was also a need to recruit and train new staff; some of this training was achieved through the secondment of national experts from accession countries. At this point in time, Bulgaria and Romania were not part of the EU, but due to the short timeframe for them to join, the EMA also started cooperating with their national agencies.