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At a high level, new regulatory requirements in emerging markets have a significant effect on matters such as product design,
commercialization, and market-entry strategies. The regulatory environment in Europe is evolving, with significant effort
to make regulations, including those governing pharmaceuticals and medical devices, more uniform across the region. Change
toward harmonization has come in waves and has been characterized by country assimilation into the European Union. Countries
can be grouped, therefore, by their status: the "original" (largely more western) member states, the "new" member states (including
Bulgaria, Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia), "candidate"
countries (Croatia, Macedonia, Montenegro, Serbia, and Turkey), and potential candidate countries (Albania, Bosnia and Herzegovina,
and Kosovo).
Jill E. Sackman
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While current country-specific trends may vary within and across Eastern Europe (given that each country is moving towards
harmonizing with the EU at a different rate), countries can be grouped based on where they are in their evolution. Regardless,
it can be expected that they're all moving towards a similar goal of harmonized regulations.
Key regulatory considerations
New member states. New member states must meet the same regulatory standards as the rest of the EU. In addition to the CE
stamp, regulatory submission to the competent authority of the appropriate member state(s) is required for all interventional
studies for pharmaceuticals, and all late-phase studies for medical devices. All countries have internal agencies that review
products (such as the Bulgarian Drug Agency, or the Hungarian Health Science Council). Medical devices must also get approval
from notified bodies, which are accredited organizations that are recognized by the EU to audit quality systems, test devices,
and make sure they meet applicable standards.
Once products are approved, they will have to meet EU standard GMPs. The EU does have an agreement in place with FDA to share
facility inspection data. EU regulatory standards, like FDA's, are based on those developed by the World Health Organization
(WHO), but are regularly revised by the European Medicines Agency (EMA) and the European Commission on Public Health. GMP
inspections are performed by each country's national regulatory agency, so while the guidelines may be standard across the
countries, there may be country-specific political, social, and cultural considerations to take into account as well. Regulations
are open to interpretation, so the way that even consistent regulations are interpreted within each country may be influenced
by the biases of each country's leaders. As a result, having the right regulatory contacts in each country will be crucial.
Candidate countries and potential member states. Candidate countries and potential candidate countries must aim to meet the
same requirements as those already a part of the EU. These countries all utilize a central body to approve products on a state
level, while their notification, registration, and ethics requirements vary by country. These states may still need to do
some work to harmonize with the other members of the EU in terms of regulatory processes, especially those that are earlier
in the process of joining the EU.
To that end, the European Commission has launched the Instrument for Pre-accession Assistance Programme to assist these countries
in the efforts to align with EMA requirements. The program includes a number of meetings and conferences to train the relevant
national authorities. Generally, these nations have begun to set in place requirements to better align with EMA, adhering
to similar exclusivity agreements and adjusting their inspection practices. Several nations have limited documentation of
their activities, which may prove that they are not as organized in practice as they are on paper.
