Regulatory Focus™ > News Articles > Japan Joins Switzerland, Australia on List of Countries With API Quality Standards Equal to EU

Japan Joins Switzerland, Australia on List of Countries With API Quality Standards Equal to EU

Posted 06 June 2013 | By Alexander Gaffney, RAC

On 2 July 2013, new rules are set to go into effect in the European Union that radically change the process by which active pharmaceutical ingredients (APIs) manufactured outside the EU enter into the region. And while many countries are scrambling to get basic systems into place that will allow the manufacturers they regulate to meet the rules, Japan has now joined a small but elite group of nations that will be able to bypass many of the rules' most onerous provisions.


In an announcement on 4 June 2013 in the Official Journal of the European Union, the European Commission said it would add Japan to a list of non-EU countries with a regulatory framework equal to that of the EU's for active substances for medicinal products for human use (i.e. APIs).

Under the pending rule, known as Directive 2011/62/EU, all entities importing products into the EU will have to receive "written confirmation" from their respective country's approved regulator that the API is produced to the EU's current good manufacturing practice (CGMP) standards.

The one exception is if the EU decides that a country's CGMP standards match its own, thereby eliminating the need for the written confirmation. Those countries meeting this exception are to be added to the European Commission's list, but must request to be added first, which Japan did in December 2012.

On 4 June 2013, Japan's request was approved, and the country will be added to the list on 25 June 2013.

Other Countries Seek Same Ends

At present, Switzerland and Australia are the only other approved countries on the list, which notably excludes the US Food and Drug Administration and Health Canada, two established regulatory bodies that interface closely with the European Medicines Agency, the EU's principal regulator, in global regulatory matters and most notably on the International Conference on Harmonisation (ICH).

Israel's regulator has reportedly also asked for an exemption to the EU API import written confirmation process, but does not appear to have been approved at this time. Other countries, including Brazil, China and India (2), have recently announced the details of their written confirmation procedures.

European Commission: Japan Meets API Standards

Explanation of API Rule

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