Under the falsified medicines directive, from next year active pharmaceutical ingredients (API) made outside the European Union (EU) must be manufactured to standards equivalent to the region’s good manufacturing practices (GMP) regulations.
The rules also state that a non-EU exporter’s compliance with appropriate standards must be confirmed in writing by local regulators, unless the country in question is granted exemption for the rules.
The new ruling means Switzerland is the first country granted such exemption and the first to be named on a list of ‘third countries’ that will be maintained by the EC.
The Commission said: “After a successful assessment, the European Commission concluded that the regulatory framework applicable to active substances exported to the Union from Switzerland, the respective controls and the enforcement activities are equivalent to those of the Union.”
New requests?
How many more exemption requests the EC is likely to receive is unclear, but any country that does want to achieve such status by the time the new import laws come into effect next July will need to move fast.
Switzerland originally made its request in April, nearly eight months ago. Israel, which asked for similar status just one month later, is still undergoing equivalence assessment.
Similar exemption requests submitted by authorities in Australia and Singapore in September and Brazil last month are also still being reviewed with no decision date announced.
Previous inspections
Beyond the extended review process, another factor that may put countries off making such requests is the EC’s decision to allow data from previous inspections of API plants to be used in written confirmations
In a Q&A document issued last month the Commission said that non-EU countries do not have inspect a facility specifically for the purpose of issuing the 'written confirmation' if it has already passed inspection by an EU regulatory authority of an equivalent group.
In such circumstances regulators in countries where API suppliers have passed inspections by – for example the US Food and Drug Administration (FDA) – may decide that seeking exemption from EU import laws is unnecessary.