The availability of medications in Eastern Europe has been affected by differences in the medicine registration process of the region, compared to the EU.
The EU uses a single marketing authorization from the European Medicines Agency (EMA), which is valid in all EU member states, streamlining the process for pharmaceutical companies to bring their products to market.
The process and requirements for medicine registration in Eastern Europe can also differ from those in the EU. As a result, some medications may be available later, or not at all, in Eastern Europe compared to the EU. This can impact access to innovative treatments for patients in the region - Romania, for example does not have 8,995 molecules that are registered MA’s in the EU27.
In recent years, some Eastern European countries have been working to align their regulatory systems with EU standards in order to reduce disparities in the availability of medications, and ultimately improving patient access (the Joint Baltic Drug Procurement Agreement between the Baltic states is an example of this). This effort to coordinate regulations across the region will help to support the development of an integrated market for pharmaceuticals in Eastern Europe.
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