The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

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

Jan. 6, 2017

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.

Information shared by the regulators includes the names of active substances and APIs manufactured at the site, the facility’s master file, product quality review data, manufacturing process descriptions, and a list of the buildings schedule for inspection.

Navigating EU pharmacovigilance requirements is a complex task that starts in the early stages of drug development and extends right through the drug's life. This report, Pharmacovigilance in the European Union, will help readers navigate the EU’s regulatory landscape.

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