The EMA has adopted a policy for handling GMP non-compliance information from other regulators or international organisations.
Adoption of the policy comes as the European Medicines Agency (EMA) and other regulators attempt to maintain oversight of an increasingly globalised supply chain. In the document the EMA outlines how staff should handle GMP (good manufacturing practice) information from third-countries.
“Notification of serious GMP non-compliance from a third country authority or an international organisation should be assessed to determine the impact with respect to medicinal products supplied to the Community”, the EMA wrote in a compilation of its regulatory procedures .
The EMA adopted the policy in May and it will come into force by the end of November. Before the policy was created the EMA had no written policy for handling GMP non-compliance information it received from other regulators.