Russia may impose new GMP requirements for drug imports

The Russian government is considering introducing mandatory requirements of the compliance to Good Manufacturing Practices (GMP) standards of all the drug imports coming into Russia, according to local reports.

Currently, this requirement is only applied to domestic producers, which must transfer their production processes to GMP standards by 2014; all Russian drug makers should switch to international standards of quality, otherwise their license will cease to operate.

In the case of importers, according to state plans, all of them should have documents, confirming the use of GMP standards.  So far, Russian GMP standards have not yet been finally approved. The recently proposed standard is the adapted translation of the European Union GMP standards, said deputy director of Stada CIS Ivan Glushkov.