Japan Meets GMP Standards for API Import

Starting July 2, 2013, the European Commission will require all Active Pharmaceutical Ingredient (API) manufacturers to meet EU current good manufacturing practice (CGMP) standards before importing products into the EU. The new regulations were passed in 2011, but countries from India to China are still struggling to put into place compliance systems before the deadline.

Japan, by contrast, received news on June 4, 2013 that it will be exempt from the main rule for CGMP compliance. That rule charges API importers to submit “written confirmation” of compliance from their country’s approved regulator.

Countries considered to have the same CGMP standards as the EU are exempt from the process. In addition to Japan, the list of exempt countries includes Australia, Switzerland and the US.