FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Japan to Share GMP Inspection Findings on API Makers With EU, FDA, TGA

Dec. 22, 2016
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Japan’s Pharmaceutical and Medical Devices Agency is joining the ranks of the FDA, the EMA and a few other drug regulators by agreeing to participate in a program that allows the agencies to share GMP inspection plans and results for API manufacturing sites.

The drug regulators conduct their inspections in compliance with GMP standards laid out in the ICH guideline Q7 for the manufacturing practices of APIs, and provisions in the program allow the regulators to request that an agency expands the scope of their inspection to meet the needs of more than one agency in the program.

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