EU API law causing concern among API producers

Home/Policies & Legislation | Posted 22/03/2013 post-comment0 Post your comment

Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013, all imported APIs were required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP and as of 2 July 2013 this compliance must be confirmed in writing by the competent authority of the exporting country. Alternatively, the country may request listing (on the ‘white list’) if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.

API V13C22

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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Source: EC, EMA, FDA, HMA

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