The QMN Weekly Bulletin

FDA, EMA to Collaborate on Inspections for Generic Applications

Dec. 27, 2013

The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications.

Regulators from the FDA, EMA and several EU member states will share information on inspections of these facilities, conduct joint inspections of the sites and work together to train inspectors.

As part of the initiative, the regulators hope to speed up the identification of manufacturing problems that raise questions about the reliability of data submitted in bioequivalence studies used to verify that generic drugs are substitutable for their brand counterparts.

The program builds upon the successful FDA/EMA joint good clinical practices inspection initiative launched in 2009.

Both programs were designed to help the regulators better “leverage inspection resources” to address the challenges of increased globalization in the pharmaceutical industry, according to CDER director Janet Woodcock.

An 18-month pilot phase of the generic drug application inspection initiative will launch Jan. 2.

The EU member states participating in the program are France, Germany, Italy, the Netherlands and the United Kingdom.

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