Polish Drugmakers Urge Reform of Drug Registration

Pharmaceutical firms present in Poland are urging changes to the country's drug registration process, claiming the system is approaching bureaucratic deadlock. Some companies note that registration can take "several years" in Poland, mainly as drugs are officially unregistered until pricing has been set.

The delays are given greater urgency as the so-called transitional period, during which Poland must harmonise regulations with the European Union (EU), is due to expire at the end of 2008. By this time, all drugs currently sold and registered under the old system must be re-registered.

Nevertheless, the government does appear to be making some progress on reform. A draft amendment to the Pharmaceutical Law will separate drug registration and reimbursement in Poland, taking away some of the Health Ministry's responsibilities and passing them to registration agency URPL.

Under the plans, the agency will also publish the list of registered products, monitor adverse drug reactions and manage the register of clinical trials. However, whether this modernising drive will actually improve URPL's backlog -- and include the necessary extra funding and staff -- remains to be seen.