Many competent authorities from countries exporting APIs to the EU are concerned that they may not be able to put the necessary systems in place by July 2013 to be able to issue written confirmation of GMP compliance.

The problem is that although the EU adopted Directive 2011/62/EU in July 2013, the European Commission (EC) only issued templates and detailed guidance on the implementation of the rules in July 2012.

While the US has asked for exemption, it is thought to be unlikely that China and India, which make up an estimated 15% of APIs imported into the EU, will be ready to meet the July 2013 deadline.

The other problem is that the EC is assessing countries that have submitted listing requests to determine which countries have equivalent rules for GMPs and may therefore be exempt from providing written confirmation. APIs are imported into the EU from approximately 1,560 sites in 43 different countries, however, it is estimated that 300 API sites may still require inspection. Given that the resources available at the EU level may only be able to carry out 25 such assessments, this will leave many API sites without certification.

The Heads of Medicines Agency (HMA) has therefore expressed its concern that the main API producing countries exporting to the EU will not be on the ‘white list’ nor will national manufacturers of APIs have a ‘written confirmation’ of compliance. HMA is concerned that this might lead to shortages of medicines within Europe and consequently become a serious public health risk.

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