Preparing for the next wave
In late 2009, the EMA launched its Instrument for the Pre-accession Assistance (IPA) programme, for EU candidate countries
in pre-accession activities (3), which included Croatia, the former Yugoslav Republic of Macedonia, Turkey, Albania, Bosnia
and Herzegovina, Kosovo, Montenegro and Serbia. An earlier initiative, backed by €600000 from the EC, had focused on supporting
the participation of the former Yugoslav Republic of Macedonia, Croatia and Turkey in EMA activities.
To fund the latest IPA programme, from 2009 to 2011, a budget of €900000 was requested from the EC (3). In a similar fashion
to the approach the EMA adopted for the EU's expansion in 2004, nominated representatives of the candidate countries were
invited to selected meetings and training courses as observers. As well as scientific training, a number of legal measures
were also conducted so that EU technical regulations could be transposed into the national legislation of the participating
candidate and potential candidate countries. According to the EMA, the programme is not only for the national agencies to
gain experience of the current system, but also for them to feel that they are equal, mutually respected partners. As part
of this, the EMA sends members of its staff to the countries to talk to the national agencies about their respective needs.
The scope of the project was expected to vary according to the needs of the country concerned and the stage of its candidacy
(6). The EMA has adopted a three-step approach to training, moving from general topics through to more specific ones. Initially,
information regarding the pan-European approach to regulations is provided to national representatives at the EMA headquarters
in London (UK). The next step is a series of conferences held within candidate and potential candidate countries, which involves
representatives from the pharma industry, as well as other interested parties. This allows the national agencies not only
to develop a solid understanding of the EMA's work and processes, but also to understand which stakeholders are involved and
how to interact with them. The third training step involves participation from national experts in specific training sessions
organised in London.
The EMA is confident in its system and believes that the step-wise training will ensure the implementation and enforcement
of harmonised regulatory and technical requirements. It also aims to make sure that any divergent practices still existing
within candidate and potential candidate countries are eradicated in time for their entry into the EU. Progress of the overall
IPA project is to be monitored by the EMA's Administrative Unit, with checks to ensure that goals are being achieved and that
sufficient time is allocated to carry out remaining activities. Annual reports will be posted on the EMA website (6).
Of all the countries involved in the IPA process, Croatia is working particularly closely with the EMA, since it is due to
enter the EU on 1 June 2012. Indeed, so far, the only detailed reports available on the EMA website relating to candidate
countries are for Croatia. The work with Croatia was kick-started in November 2008, when a conference involving more than
350 participants was held in Rijeka (7). The meeting was timed to coincide with the fifth anniversary of the Croatian Agency
for Medicinal Products and Medical Devices (ALMP), and featured presentations from experts at the EC, the EMA, the ALMP and
the National Medicines Agency of Romania. The involvement of Romania's regulatory agency was considered particularly important
because as a recent EU entrant, it was able to offer its Croatian counterparts a unique perspective on the post-accession
In January 2011, the EMA and the ALMP began a pre-accession linguistic checking process for product information in the Croatian
language (3). Guidance documents, available on the EMA website, have been prepared to explain how marketing-authorisation
holders should translate their product information into Croatian and submit it for checking. There are also product information
templates translated into Croatian, and reference documents for the Croatian translations of European country names and non-standard
terms used in product information. A phasing-in process for EC decisions on centrally authorised medicines will take place
to coincide with Croatia's entry date, which will avoid any delays in the supply of medicines to Croatia, as well as prevent
any non-compliant products with Croatian translations gaining access to the markets of other EU member states.
Prior to the 2004 expansion of the EU, some observers had expressed concern at the inclusion of Central and Eastern European
countries and how they might affect pharmaceutical regulation. A primary concern was that these new countries had never had
a chance to influence the development of EU regulations in line with their capabilities (8). Some countries were also believed
to lack the institutional structures to meet new regulatory standards, and the means to sufficiently implement and enforce
European regulations (8). It would appear that these views were rather pessimistic. Despite the fact that newer entrant countries
have had limited regulatory experience for pan-European matters, the EMA is already preparing for a new wave of expansion.