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Regulatory Focus™ > News Articles > Japan Joins International API Manufacturing Inspection Program

Japan Joins International API Manufacturing Inspection Program

Posted 15 December 2016 | By Zachary Brennan 

Japan Joins International API Manufacturing Inspection Program

Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs).

“PMDA has decided to join this program from 24 November 2016,” the agency said in an announcement. “The participation in the program allows PMDA, under confidential arrangements, to share information related to GMP inspections such as inspection plans and inspection results. By utilizing such information, PMDA will be able to effectively and reasonably conduct GMP inspection with higher quality. PMDA will also provide the similar information to the regulators participating in the program.”

The reference GMP standard for the inspections is ICH Q7: Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, and for sterile active substances and APIs (not covered by ICH Q7), the involved authorities, which also includes Australia’s Therapeutic Goods Administration, will follow additional regional guidelines as appropriate.

Under the international program, which began as a pilot project in 2008 and was fully implemented in 2012, participating regulatory authorities may request another participant to expand the scope of a planned inspection to cover areas of interest to more than one participating authority, according to an EMA outline of the program.

In terms of information exchanged, the inspectors are expected to share at least the active substance and API name(s) made at the site, the site master file, product quality review data, manufacturing process descriptions (at least a flow-chart) and building/lines to be inspected.

The agreement follows further collaborations between the PMDA and the European Directorate for the Quality of Medicines and Healthcare announced in October to further share information on API inspections.

Both regulators began sharing such inspection data back in 2013, though mutual recognition agreements date back to 2003.

PMDA Statement

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