In an attempt to crack down on substandard and ersatz ingredients entering the supply chain, the European Commission issued directive 2011/62/EU – originally published in June 2011 – to block the importation of active pharmaceutical ingredients (APIs) manufactured in countries outside the EU without written confirmation that the production facility meets appropriate standards from local regulators.
With just three weeks to go before the rules are to be implemented, Japan has joined Switzerland and Australia as so-called ‘third-countries’ - non-EU countries exempt from the import rule due to having a regulatory framework deemed equal to that of the EU for API manufacturing and inspection standards.
Countries can apply for exemption from having to provide written assurances of quality when shipping to the EU by supplying the Commission with a series of documentation and information before undergoing an EU equivalence assessment. Required information includes:
- National legislation relating to the manufacture of APIs and to the inspections of API manufacturers and information on how they may differ from internationally-agreed guidelines, such as those of the ICH Q7 or WHO
- The total number and list of registered API manufacturers in the country and those exporting APIs to the EU
- The total number of inspectors and the average number of API sites inspected annually per inspector
According to the amending Implementing Decision , dated June 4, Japan requested to be a ‘third-country’ in a letter from December 6 2012, and the equivalence assessment by the EC confirmed that the requirements were fulfilled.
Other countries who have applied for exemption to the approaching GMP import regulation, according to an EC public health notice , are Israel and Singapore who both have ongoing contact with the EC, and Brazil and the US who are in the middle of equivalence assessments.