European Drugmakers Propose Approach to Prevent Shortages

Saturday, February 7, 2015

Source: FDA News

Europe’s brand and generic drugmakers are proposing a coordinated approach for regulators and industry to quickly identify and respond to drug shortages caused by manufacturing and quality issues.

The centerpiece of the scheme is a uniform template drugmakers would use to report problems that could cause shortages. The form would ensure consistency in the information gathered and improve coordination by regulators in the affected countries. Supply interruptions would be color-coded: red for high risk, yellow for medium risk and green for low risk.

Drugmakers would be required to include details about themselves and the product, the causes of the potential shortage, expected duration, steps planned or taken to address the shortage, the affected countries, notification to other parties and the name of the person completing the form and the date.

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