In an attempt to impose GMP standards throughout the world, the EU has introduced new rules for importing active pharmaceutical ingredients (APIs) for human use into Europe.

The move comes as part of efforts to stop the import of counterfeit or substandard APIs for human use medicines. Under the Falsified Medicines Directive the EU requires that as of 2 January 2013 all imported APIs must be manufactured in compliance with standards of GMP at least equivalent to those required in the EU. 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.

The listing means that Japan joins an exclusive group of only three countries so far that will be exempt from having to provide written confirmation of compliance for APIs exported from the country.

According to the commission’s decision of 4 June 2013 Japan requested to be listed by letter dated 6 December 2012 and subsequent assessment confirmed that Japan’s GMP requirements were equivalent to those of the EU. Switzerland made it to the list in November 2012 and Australia in April 2013. The US has also requested listing, and the EU Pharmaceutical Committee was planning to carry out on-site audit visits for the US in mid-May 2013, but there has been no decision as yet [1].

Israel and Singapore have also applied for listing, but have been refused listing ‘for the time being’. Brazil has also requested listing, but has apparently not yet sent the relevant documentation to the EU Pharmaceutical Committee. Brazil, Israel and Singapore will therefore have to provide written confirmation of compliance with EU GMP for the time being.

The progress of the Commission has been described as slow and there have been concerns raised that countries may face drug shortages due to drug companies not being able to import APIs into the EU after 2 July 2013. One major concern has been for India and China, which make up an estimated 15% of APIs imported into the EU. And, although India has now issued finalized guidelines for drugmakers to comply with the EU law and is optimistic that the country’s drug firms will be ready in time, it is feared some Chinese firms would not have the written confirmations necessary in order to import APIs into the EU.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. China and India still to comply with new EU API rules [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 21]. Available from: www.gabionline.net/Policies-Legislation/China-and-India-still-to-comply-with-new-EU-API-rules

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